Negotiating Hope and Acceptance

Transcription

Negotiating
Hope and
Acceptance
Emotional recovery
demands delicate
compromises
• What I Can Do
• A Young Mother’s Stroke
• Life Is Tough, People Are Tougher
• Diabetes and Stroke
• Thoughts and Feelings after Stroke
contents
nts
November/December 2006
24
Feature Story
Negotiating Hope and Acceptance 24
How survivors and caregivers can regain a sense
of control in the face of an uncertain future.
What I Can Do 18
Twenty-year-survivor Bill Janson attends seven braininjury support groups each month. That’s how he
spreads the word that there is life after stroke.
A Young Mother’s Stroke 21
“The hardest part was lying in bed after brain
surgery, pondering what my four-year-old son
Dawson would think when he saw me.”
Life Is Tough, People Are Tougher 30
We talked to an expert on emotional resilience.
He says you’re tougher than you think.
Diabetes and Stroke 34
21
38
What stroke families should know about the
cardiovascular consequences of diabetes.
Thoughts and Feelings after Stroke 38
Caregiver Marvel Peters shares how she has
negotiated the difficult passage between hope
and acceptance in her husband’s recovery.
Departments
Letters to the Editor 3
Stroke Notes 8
Readers Room 12
Life at the Curb 41
Everyday Survival 42
Stroke Connection Magazine is underwritten
in part by Bristol-Myers Squibb/Sanofi
Pharmaceuticals Partnership, makers of Plavix.
Produced and distributed in cooperation
with Vitality Communications
a division of
Staff and Consultants:
Jon Caswell, Lead Editor
Copyright 2006 American Heart Association ISSN 1047-014X
Dennis Milne, Vice President,
American Stroke Association
Mike Mills, Writer
Wendy Segrest, Director, American
Stroke Association Operations
Pierce Goetz, Art Director
Stroke Connection Magazine is published six times a year by the American
Stroke Association, a division of the American Heart Association. Material
may be reproduced only with appropriate acknowledgment of the source
and written permission from the American Heart Association. Please
address inquiries to the Editor-in-Chief.
The information contained in this publication is provided by the
American Stroke Association as a resource. The services or products
listed are not owned or provided by the American Stroke Association.
Additionally, the products or services have not been evaluated and their
listing should not be construed as a recommendation or endorsement of
these products or services.
Debi McGill, Editor-in-Chief
1-888-4STROKE (1-888-478-7653)
Jim Batts, Writer
Michelle Neighbors,
Advertising Sales
StrokeAssociation.org
YOU DON’T
WANT ANOTHER
HEART ATTACK
OR ANOTHER
STROKE
TO SNEAK UP
ON YOU.
WITHOUT PLAVIX
PLAVIX HELPS KEEP BLOOD PLATELETS
FROM STICKING TOGETHER AND FORMING
CLOTS, WHICH HELPS PROTECT YOU FROM
ANOTHER HEART ATTACK OR STROKE.
If you’ve had a heart attack or stroke, the last thing you
need is another one sneaking up on you. PLAVIX may
help. PLAVIX is a prescription medication for people
who have had a recent heart attack or recent stroke, or
who have poor circulation in the legs, causing pain
(peripheral artery disease).
PLAVIX OFFERS PROTECTION.
PLAVIX is proven to help keep blood platelets from
sticking together and forming clots, which helps keep
your blood flowing. This can help protect you from
another heart attack or stroke.
IMPORTANT INFORMATION: If you have a stomach
ulcer or other condition that causes bleeding, you
shouldn't use Plavix. When taking Plavix alone or with
some medicines including aspirin, the risk of bleeding
may increase.To minimize this risk, talk to your doctor
before taking aspirin or other medicines with Plavix.
Additional rare but serious side effects could occur.
WITH PLAVIX
TALK TO YOUR DOCTOR ABOUT PLAVIX.
For more information, visit www.plavix.com or call
1-800-609-7515
PROVEN TO HELP PROTECT FROM
ANOTHER HEART ATTACK OR STROKE
© 2006 Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership.
USA.CLO.06.03.80/March 2006
sanofi-aventis U.S. LLC
B1-K0237/03-06
PLAVIX®
Rx only
clopidogrel bisulfate tablets
INDICATIONS AND USAGE
PLAVIX (clopidogrel bisulfate) is indicated for the reduction of atherothrombotic events as
follows:
• Recent MI, Recent Stroke or Established Peripheral Arterial Disease
For patients with a history of recent myocardial infarction (MI), recent stroke, or established
peripheral arterial disease, PLAVIX has been shown to reduce the rate of a combined endpoint of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death.
• Acute Coronary Syndrome
For patients with acute coronary syndrome (unstable angina/non-Q-wave MI) including
patients who are to be managed medically and those who are to be managed with percutaneous coronary intervention (with or without stent) or CABG, PLAVIX has been shown to
decrease the rate of a combined endpoint of cardiovascular death, MI, or stroke as well as
the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia.
CONTRAINDICATIONS
The use of PLAVIX is contraindicated in the following conditions:
• Hypersensitivity to the drug substance or any component of the product.
• Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.
WARNINGS
Thrombotic thrombocytopenic purpura (TTP):
TTP has been reported rarely following use of PLAVIX, sometimes after a short exposure
(<2 weeks). TTP is a serious condition that can be fatal and requires urgent treatment
including plasmapheresis (plasma exchange). It is characterized by thrombocytopenia,
microangiopathic hemolytic anemia (schistocytes [fragmented RBCs] seen on peripheral
smear), neurological findings, renal dysfunction, and fever. (See ADVERSE REACTIONS.)
PRECAUTIONS
General
PLAVIX prolongs the bleeding time and therefore should be used with caution in patients who
may be at risk of increased bleeding from trauma, surgery, or other pathological conditions
(particularly gastrointestinal and intraocular). If a patient is to undergo elective surgery and
an antiplatelet effect is not desired, PLAVIX should be discontinued 5 days prior to surgery.
Due to the risk of bleeding and undesirable hematological effects, blood cell count determination and/or other appropriate testing should be promptly considered, whenever such suspected clinical symptoms arise during the course of treatment (see ADVERSE REACTIONS).
In patients with recent TIA or stroke who are at high risk for recurrent ischemic events, the
combination of aspirin and PLAVIX has not been shown to be more effective than
PLAVIX alone, but the combination has been shown to increase major bleeding.
GI Bleeding: In CAPRIE, PLAVIX was associated with a rate of gastrointestinal bleeding of
2.0%, vs. 2.7% on aspirin. In CURE, the incidence of major gastrointestinal bleeding was 1.3%
vs 0.7% (PLAVIX + aspirin vs. placebo + aspirin, respectively). PLAVIX should be used with
caution in patients who have lesions with a propensity to bleed (such as ulcers). Drugs that
might induce such lesions should be used with caution in patients taking PLAVIX.
Use in Hepatically Impaired Patients: Experience is limited in patients with severe hepatic
disease, who may have bleeding diatheses. PLAVIX should be used with caution in this
population.
Use in Renally-impaired Patients: Experience is limited in patients with severe renal
impairment. PLAVIX should be used with caution in this population.
Information for Patients
Patients should be told it may take them longer than usual to stop bleeding, that they may
bruise and/or bleed more easily when they take PLAVIX or PLAVIX combined with aspirin,
and that they should report any unusual bleeding to their physician. Patients should inform
physicians and dentists that they are taking PLAVIX and/or any other product known to
affect bleeding before any surgery is scheduled and before any new drug is taken.
Drug Interactions
Study of specific drug interactions yielded the following results:
Aspirin: Aspirin did not modify the clopidogrel-mediated inhibition of ADP-induced
platelet aggregation. Concomitant administration of 500 mg of aspirin twice a day for 1 day
did not significantly increase the prolongation of bleeding time induced by PLAVIX. PLAVIX
potentiated the effect of aspirin on collagen-induced platelet aggregation. PLAVIX and
aspirin have been administered together for up to one year.
Heparin: In a study in healthy volunteers, PLAVIX did not necessitate modification of the
heparin dose or alter the effect of heparin on coagulation. Coadministration of heparin had
no effect on inhibition of platelet aggregation induced by PLAVIX.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): In healthy volunteers receiving naproxen,
concomitant administration of PLAVIX was associated with increased occult gastrointestinal
blood loss. NSAIDs and PLAVIX should be coadministered with caution.
Warfarin: Because of the increased risk of bleeding, the concomitant administration of
warfarin with PLAVIX should be undertaken with caution. (See PRECAUTIONS– General.)
Other Concomitant Therapy: No clinically significant pharmacodynamic interactions were
observed when PLAVIX was coadministered with atenolol, nifedipine, or both atenolol and
nifedipine. The pharmacodynamic activity of PLAVIX was also not significantly influenced by
the coadministration of phenobarbital, cimetidine or estrogen.
The pharmacokinetics of digoxin or theophylline were not modified by the coadministration
of PLAVIX (clopidogrel bisulfate).
At high concentrations in vitro, clopidogrel inhibits P450 (2C9). Accordingly, PLAVIX may
interfere with the metabolism of phenytoin, tamoxifen, tolbutamide, warfarin,
torsemide, fluvastatin, and many non-steroidal anti-inflammatory agents, but there
are no data with which to predict the magnitude of these interactions. Caution should be
used when any of these drugs is coadministered with PLAVIX.
In addition to the above specific interaction studies, patients entered into clinical trials
with PLAVIX received a variety of concomitant medications including diuretics, beta-blocking
agents, angiotensin converting enzyme inhibitors, calcium antagonists, cholesterol
lowering agents, coronary vasodilators, antidiabetic agents (including insulin),
antiepileptic agents, hormone replacement therapy, heparins (unfractionated and
LMWH) and GPIIb/IIIa antagonists without evidence of clinically significant adverse interactions. The use of oral anticoagulants, non-study anti-platelet drug and chronic NSAIDs was
not allowed in CURE and there are no data on their concomitant use with clopidogrel.
Drug/Laboratory Test Interactions
None known.
Carcinogenesis, Mutagenesis, Impairment of Fertility
There was no evidence of tumorigenicity when clopidogrel was administered for 78 weeks
to mice and 104 weeks to rats at dosages up to 77 mg/kg per day, which afforded plasma
exposures >25 times that in humans at the recommended daily dose of 75 mg.
Clopidogrel was not genotoxic in four in vitro tests (Ames test, DNA-repair test in rat hepatocytes, gene mutation assay in Chinese hamster fibroblasts, and metaphase chromosome analysis of human lymphocytes) and in one in vivo test (micronucleus test by oral route in mice).
Clopidogrel was found to have no effect on fertility of male and female rats at oral doses
up to 400 mg/kg per day (52 times the recommended human dose on a mg/m2 basis).
Pregnancy
Pregnancy Category B. Reproduction studies performed in rats and rabbits at doses up to
500 and 300 mg/kg/day (respectively, 65 and 78 times the recommended daily human dose
on a mg/m2 basis), revealed no evidence of impaired fertility or fetotoxicity due to clopidogrel. There are, however, no adequate and well-controlled studies in pregnant women.
Because animal reproduction studies are not always predictive of a human response, PLAVIX
should be used during pregnancy only if clearly needed.
Nursing Mothers
Studies in rats have shown that clopidogrel and/or its metabolites are excreted in the milk.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted
in human milk and because of the potential for serious adverse reactions in nursing infants,
a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the nursing woman.
Pediatric Use
Safety and effectiveness in the pediatric population have not been established.
Geriatric Use
Of the total number of subjects in controlled clinical studies, approximately 50% of patients
treated with PLAVIX were 65 years of age and over. Approximately 16% of patients treated
with PLAVIX were 75 years of age and over.
The observed difference in risk of thrombotic events with clopidogrel plus aspirin versus
placebo plus aspirin by age category is provided in Figure 3 (see CLINICAL STUDIES). The
observed difference in risk of bleeding events with clopidogrel plus aspirin versus placebo
plus aspirin by age category is provided in Table 3 (see ADVERSE REACTIONS).
ADVERSE REACTIONS
PLAVIX has been evaluated for safety in more than 17,500 patients, including over 9,000
patients treated for 1 year or more. The overall tolerability of PLAVIX in CAPRIE was similar
to that of aspirin regardless of age, gender and race, with an approximately equal incidence
(13%) of patients withdrawing from treatment because of adverse reactions. The clinically
important adverse events observed in CAPRIE and CURE are discussed below.
Hemorrhagic: In CAPRIE patients receiving PLAVIX, gastrointestinal hemorrhage occurred
at a rate of 2.0%, and required hospitalization in 0.7%. In patients receiving aspirin, the corresponding rates were 2.7% and 1.1%, respectively. The incidence of intracranial hemorrhage was 0.4% for PLAVIX compared to 0.5% for aspirin.
In CURE, PLAVIX use with aspirin was associated with an increase in bleeding compared to
placebo with aspirin (see Table 3). There was an excess in major bleeding in patients receiving PLAVIX plus aspirin compared with placebo plus aspirin, primarily gastrointestinal and
at puncture sites. The incidence of intracranial hemorrhage (0.1%), and fatal bleeding
(0.2%), were the same in both groups.
The overall incidence of bleeding is described in Table 3 for patients receiving both PLAVIX
and aspirin in CURE,
Table 3: CURE Incidence of bleeding complications (% patients)
Event
PLAVIX
Placebo
P-value
(+ aspirin)*
(+ aspirin)*
(n=6259)
(n=6303)
Major bleeding †
3.7 ‡
2.7 §
0.001
Life-threatening bleeding
2.2
1.8
0.13
Fatal
0.2
0.2
5 g/dL hemoglobin drop
0.9
0.9
Requiring surgical intervention
0.7
0.7
Hemorrhagic strokes
0.1
0.1
Requiring inotropes
0.5
0.5
Requiring transfusion (≥4 units)
1.2
1.0
Other major bleeding
1.6
1.0
0.005
Significantly disabling
0.4
0.3
Intraocular bleeding with
significant loss of vision
0.05
0.03
Requiring 2-3 units of blood
1.3
0.9
Minor bleeding ¶
5.1
2.4
<0.001
* Other standard therapies were used as appropriate.
† Life threatening and other major bleeding.
‡ Major bleeding event rate for PLAVIX + aspirin was dose-dependent on aspirin:
<100 mg=2.6%; 100-200 mg= 3.5%; >200 mg=4.9%
Major bleeding event rates for PLAVIX + aspirin by age were: <65 years = 2.5%, ≥65 to
<75 years = 4.1%, ≥75 years 5.9%
§ Major bleeding event rate for placebo + aspirin was dose-dependent on aspirin:
<100 mg=2.0%; 100-200 mg= 2.3%; >200 mg=4.0%
Major bleeding event rates for placebo + aspirin by age were: <65 years = 2.1%, ≥65 to
<75 years = 3.1%, ≥75 years 3.6%
¶ Led to interruption of study medication.
Ninety-two percent (92%) of the patients in the CURE study received heparin/LMWH, and the
rate of bleeding in these patients was similar to the overall results.
There was no excess in major bleeds within seven days after coronary bypass graft surgery
in patients who stopped therapy more than five days prior to surgery (event rate 4.4%
PLAVIX + aspirin; 5.3% placebo + aspirin). In patients who remained on therapy within five
days of bypass graft surgery, the event rate was 9.6% for PLAVIX + aspirin, and 6.3% for
placebo + aspirin.
Neutropenia/agranulocytosis: Ticlopidine, a drug chemically similar to PLAVIX, is associated
with a 0.8% rate of severe neutropenia (less than 450 neutrophils/μL). In CAPRIE severe
neutropenia was observed in six patients, four on PLAVIX and two on aspirin. Two of the 9599
patients who received PLAVIX and none of the 9586 patients who received aspirin had neutrophil counts of zero. One of the four PLAVIX patients in CAPRIE was receiving cytotoxic
chemotherapy, and another recovered and returned to the trial after only temporarily interrupting treatment with PLAVIX (clopidogrel bisulfate). In CURE, the numbers of patients with thrombocytopenia (19 PLAVIX + aspirin vs. 24 placebo + aspirin) or neutropenia (3 vs. 3) were similar.
Although the risk of myelotoxicity with PLAVIX (clopidogrel bisulfate) thus appears to be
quite low, this possibility should be considered when a patient receiving PLAVIX demonstrates fever or other sign of infection.
Gastrointestinal: Overall, the incidence of gastrointestinal events (e.g. abdominal pain, dyspepsia, gastritis and constipation) in patients receiving PLAVIX (clopidogrel bisulfate) was
27.1%, compared to 29.8% in those receiving aspirin in the CAPRIE trial. In the CURE trial the
incidence of these gastrointestinal events for patients receiving PLAVIX + aspirin was 11.7%
compared to 12.5% for those receiving placebo + aspirin.
In the CAPRIE trial, the incidence of peptic, gastric or duodenal ulcers was 0.7% for PLAVIX
(clopidogrel bisulfate) and 1.2% for aspirin. In the CURE trial the incidence of peptic, gastric
or duodenal ulcers was 0.4% for PLAVIX + aspirin and 0.3% for placebo + aspirin.
Cases of diarrhea were reported in the CAPRIE trial in 4.5% of patients in the PLAVIX group
compared to 3.4% in the aspirin group. However, these were rarely severe (PLAVIX=0.2% and
aspirin=0.1%). In the CURE trial, the incidence of diarrhea for patients receiving PLAVIX +
aspirin was 2.1% compared to 2.2% for those receiving placebo + aspirin.
In the CAPRIE trial, the incidence of patients withdrawing from treatment because of gastrointestinal adverse reactions was 3.2% for PLAVIX and 4.0% for aspirin. In the CURE trial,
the incidence of patients withdrawing from treatment because of gastrointestinal adverse
reactions was 0.9% for PLAVIX + aspirin compared with 0.8% for placebo + aspirin.
Rash and Other Skin Disorders: In the CAPRIE trial, the incidence of skin and appendage
disorders in patients receiving PLAVIX was 15.8% (0.7% serious); the corresponding rate in
aspirin patients was 13.1% (0.5% serious). In the CURE trial the incidence of rash or other
skin disorders in patients receiving PLAVIX + aspirin was 4.0% compared to 3.5% for those
receiving placebo + aspirin.
In the CAPRIE trial, the overall incidence of patients withdrawing from treatment because of
skin and appendage disorders adverse reactions was 1.5% for PLAVIX and 0.8% for aspirin. In
the CURE trial, the incidence of patients withdrawing because of skin and appendage disorders
adverse reactions was 0.7% for PLAVIX + aspirin compared with 0.3% for placebo + aspirin.
Adverse events occurring in ≥2.5% of patients on PLAVIX in the CAPRIE controlled clinical
trial are shown below regardless of relationship to PLAVIX. The median duration of therapy
was 20 months, with a maximum of 3 years.
Table 4: Adverse Events Occurring in ≥2.5% of PLAVIX Patients in CAPRIE
% Incidence (% Discontinuation)
Body System
PLAVIX
Aspirin
Event
[n=9599]
[n=9586]
Body as a Whole – general disorders
Chest Pain
8.3 (0.2)
8.3 (0.3)
Accidental/Inflicted Injury
7.9 (0.1)
7.3 (0.1)
Influenza-like symptoms
7.5 (<0.1)
7.0 (<0.1)
Pain
6.4 (0.1)
6.3 (0.1)
Fatigue
3.3 (0.1)
3.4 (0.1)
Cardiovascular disorders, general
Edema
4.1 (<0.1)
4.5 (<0.1)
Hypertension
4.3 (<0.1)
5.1 (<0.1)
Central & peripheral nervous system disorders
Headache
7.6 (0.3)
7.2 (0.2)
Dizziness
6.2 (0.2)
6.7 (0.3)
Gastrointestinal system disorders
Abdominal pain
5.6 (0.7)
7.1 (1.0)
Dyspepsia
5.2 (0.6)
6.1 (0.7)
Diarrhea
4.5 (0.4)
3.4 (0.3)
Nausea
3.4 (0.5)
3.8 (0.4)
Metabolic & nutritional disorders
Hypercholesterolemia
4.0 (0)
4.4 (<0.1)
Musculo-skeletal system disorders
Arthralgia
6.3 (0.1)
6.2 (0.1)
Back Pain
5.8 (0.1)
5.3 (<0.1)
Platelet, bleeding, & clotting disorders
Purpura/Bruise
5.3 (0.3)
3.7 (0.1)
Epistaxis
2.9 (0.2)
2.5 (0.1)
Psychiatric disorders
Depression
3.6 (0.1)
3.9 (0.2)
Respiratory system disorders
Upper resp tract infection
8.7 (<0.1)
8.3 (<0.1)
Dyspnea
4.5 (0.1)
4.7 (0.1)
Rhinitis
4.2 (0.1)
4.2 (<0.1)
Bronchitis
3.7 (0.1)
3.7 (0)
Coughing
3.1 (<0.1)
2.7(<0.1)
Skin & appendage disorders
Rash
4.2 (0.5)
3.5 (0.2)
Pruritus
3.3 (0.3)
1.6 (0.1)
Urinary system disorders
Urinary tract infection
3.1 (0)
3.5 (0.1)
Incidence of discontinuation, regardless of relationship to therapy, is shown in parentheses.
Adverse events occurring in ≥2.0% of patients on PLAVIX in the CURE controlled clinical trial
are shown below regardless of relationship to PLAVIX.
Table 5: Adverse Events Occurring in ≥2.0% of PLAVIX Patients in CURE
PLAVIX
Placebo
(+ aspirin)*
(+ aspirin)*
Event
[n=6259]
[n=6303]
Body as a Whole– general disorders
Chest Pain
2.7 (<0.1)
2.8 (0.0)
Headache
3.1 (0.1)
3.2 (0.1)
Dizziness
2.4 (0.1)
2.0 (<0.1)
Abdominal pain
2.3 (0.3)
2.8 (0.3)
Dyspepsia
2.0 (0.1)
1.9 (<0.1)
Diarrhea
2.1 (0.1)
2.2 (0.1)
*Other standard therapies were used as appropriate.
Other adverse experiences of potential importance occurring in 1% to 2.5% of patients
receiving PLAVIX (clopidogrel bisulfate) in the CAPRIE or CURE controlled clinical trials are
listed below regardless of relationship to PLAVIX. In general, the incidence of these events
was similar to that in patients receiving aspirin (in CAPRIE) or placebo + aspirin (in CURE).
Autonomic Nervous System Disorders: Syncope, Palpitation. Body as a Whole-general disorders: Asthenia, Fever, Hernia. Cardiovascular disorders: Cardiac failure. Central and
peripheral nervous system disorders: Cramps legs, Hypoaesthesia, Neuralgia, Paraesthesia,
Vertigo. Gastrointestinal system disorders: Constipation, Vomiting. Heart rate and rhythm
disorders: Fibrillation atrial. Liver and biliary system disorders: Hepatic enzymes increased.
Metabolic and nutritional disorders: Gout, hyperuricemia, non-protein nitrogen (NPN)
increased. Musculo-skeletal system disorders: Arthritis, Arthrosis. Platelet, bleeding & clotting disorders: GI hemorrhage, hematoma, platelets decreased. Psychiatric disorders:
Anxiety, Insomnia. Red blood cell disorders: Anemia. Respiratory system disorders:
Pneumonia, Sinusitis. Skin and appendage disorders: Eczema, Skin ulceration. Urinary system disorders: Cystitis. Vision disorders: Cataract, Conjunctivitis.
Other potentially serious adverse events which may be of clinical interest but were rarely
reported (<1%) in patients who received PLAVIX in the CAPRIE or CURE controlled clinical
trials are listed below regardless of relationship to PLAVIX. In general, the incidence of these
events was similar to that in patients receiving aspirin (in CAPRIE) or placebo + aspirin
(in CURE).
Body as a whole: Allergic reaction, necrosis ischemic. Cardiovascular disorders: Edema generalized. Gastrointestinal system disorders: Gastric ulcer perforated, gastritis hemorrhagic,
upper GI ulcer hemorrhagic. Liver and Biliary system disorders: Bilirubinemia, hepatitis infectious, liver fatty. Platelet, bleeding and clotting disorders: hemarthrosis, hematuria, hemoptysis, hemorrhage intracranial, hemorrhage retroperitoneal, hemorrhage of operative wound,
ocular hemorrhage, pulmonary hemorrhage, purpura allergic, thrombocytopenia. Red blood
cell disorders: Anemia aplastic, anemia hypochromic. Reproductive disorders, female:
Menorrhagia. Respiratory system disorders: Hemothorax. Skin and appendage disorders:
Bullous eruption, rash erythematous, rash maculopapular, urticaria. Urinary system disorders: Abnormal renal function, acute renal failure. White cell and reticuloendothelial system
disorders: Agranulocytosis, granulocytopenia, leukemia, leukopenia, neutrophils decreased.
Postmarketing Experience
The following events have been reported spontaneously from worldwide postmarketing
experience:
• Body as a whole:
-hypersensitivity reactions, anaphylactoid reactions, serum sickness
• Central and Peripheral Nervous System disorders:
-confusion, hallucinations, taste disorders
• Hepato-biliary disorders:
-abnormal liver function test, hepatitis (non-infectious), acute liver failure
• Platelet, Bleeding and Clotting disorders:
-cases of bleeding with fatal outcome (especially intracranial, gastrointestinal and
retroperitoneal hemorrhage)
-thrombotic thrombocytopenic purpura (TTP) – some cases with fatal outcome(see WARNINGS).
-agranulocytosis, aplastic anemia/pancytopenia
-conjunctival, ocular and retinal bleeding
• Respiratory, thoracic and mediastinal disorders:
-bronchospasm, interstitial pneumonitis
• Skin and subcutaneous tissue disorders:
-angioedema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal
necrolysis, lichen planus
• Renal and urinary disorders:
- glomerulopathy, increased creatinine levels
• Vascular disorders:
- vasculitis, hypotension
• Gastrointestinal disorders:
- colitis (including ulcerative or lymphocytic colitis), pancreatitis, stomatitis
• Musculoskeletal, connective tissue and bone disorders:
- myalgia
OVERDOSAGE
Overdose following clopidogrel administration may lead to prolonged bleeding time and
subsequent bleeding complications. A single oral dose of clopidogrel at 1500 or 2000 mg/kg
was lethal to mice and to rats and at 3000 mg/kg to baboons. Symptoms of acute toxicity
were vomiting (in baboons), prostration, difficult breathing, and gastrointestinal hemorrhage in all species.
Recommendations About Specific Treatment:
Based on biological plausibility, platelet transfusion may be appropriate to reverse the
pharmacological effects of PLAVIX if quick reversal is required.
DOSAGE AND ADMINISTRATION
Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
The recommended daily dose of PLAVIX is 75 mg once daily.
Acute Coronary Syndrome
For patients with acute coronary syndrome (unstable angina/non-Q-wave MI), PLAVIX
should be initiated with a single 300 mg loading dose and then continued at 75 mg once
daily. Aspirin (75 mg-325 mg once daily) should be initiated and continued in combination
with PLAVIX. In CURE, most patients with Acute Coronary Syndrome also received heparin
acutely (see CLINICAL STUDIES).
PLAVIX can be administered with or without food.
No dosage adjustment is necessary for elderly patients or patients with renal disease. (See
Clinical Pharmacology: Special Populations.)
Body System
Distributed by:
Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership
New York, NY 10016
PLAVIX® is a registered trademark of Sanofi-Synthelabo.
Brief Summary of Prescribing Information Revised February 2006
PLA-FEB06-B-Aa
L E T T E R S
C o n n e c t i n g Yo u t o U s
Being able to read
the words of other
stroke survivors and caregivers is like visiting with
people who “get it.” Thank you.
As hard as this has been for all of us, it really is
a wonderful new world. People that help are really
amazing.
Just when I’d become cynical about human nature,
this happened and reminded me of the goodness in
people. I believe all people want to do good things.
Some have a harder time, and some step up and do
something about it. This magazine is an example of
people who stepped up. I now know many. What an
experience.
Lita Lappin, Survivor
Sacramento, California
My son, a nurse, explained things to me
this way after my stroke in October 2004: “Mom,
you’re living in a construction zone. There are so many
traffic jams bottling up your nerve pathways, the wrong
messages come through.” That explanation has helped
me endure the low periods and bad days, when they
come. A strong, positive determined attitude becomes
a great motivator. I have found that I had to progress
beyond blame of anyone or anything in order to recover.
As a whole, my recovery experience has been
remarkable because of the help and therapy I
received. Prayers helped a great deal. Friends and
family volunteered in countless ways to help my
husband and me adjust to this sudden change. I
am grateful that my function is steadily improving,
even though fine-tuning can seem less dramatic than
relearning to walk.
To those who are discouraged, I urge you to keep on
until you can’t, then keep on again. Listen to the cues
your body gives you; take excellent care of yourself.
Improvement continues at its own pace, in its own
rhythm. With determination and creative thinking,
a way will open up, as illustrated by Ruth Lycke’s
acupuncture story in the March/April 2006 issue.
I’d also like to thank Lorraine Fowler and Helen
Kanen for their inspiring letters in that issue.
Orian Woods, Survivor
Mitchellville, Iowa
I am caregiver to my husband, an 11-year
stroke survivor. I have the same problems concerning
public bathrooms as Robert Sawyer (Letters, July/
August 2006).
In response to his request for more ideas, I can
recommend two places with family restrooms. While
traveling, I have found that hospitals are great places
to solve the bathroom problem. You can stop at any
hospital or clinic and usually find a co-ed or family
restroom with handicap facilities. Also, a nurse or aide
is usually available to stand guard if you have to use
the regular restroom.
My second suggestion is to stop at any casino.
They usually have a family restroom available. If
they don’t have a family one, then use a handicap
bathroom and an attendant will stand outside the door.
I have found the casinos to be very understanding of
the problem and helpful in solving it. You don’t have
to gamble, but we do.
Barbara Howard, Caregiver
Kansas City, Kansas
I have just finished
reading your March/
April 2006 issue. I like the upbeat, positive style of your
publication. It’s a chance for us to say, “OK, I had a
stroke, but I’ve come through it.”
There is no sign of the “poor me, I’ve had a stroke”
syndrome. As General De Gaulle said when told
something was impossible, “It’s necessary to will the
means.”
Chris Goodall, Survivor
Caversham, Reading, Berks, England
We Wa n t To H e a r F r o m Yo u
mail:
c/o Editor-in-Chief
Stroke Connection Magazine
7272 Greenville Ave.
Dallas, TX 75231
fax: 214-706-5231
e-mail: [email protected]
Letters may be edited for length and scientific integrity. The opinions presented are those of the individual and do not reflect those of the American Stroke Association.
3
L E T T E R S
C o n n e c t i n g Yo u t o U s
My husband had a serious stroke
three years ago. His right side is paralyzed and he is
unable to speak. I wonder if others had this problem:
When the right side of his arm or hand is touched or
stroked, he pulls it away as if it’s a painful or unpleasant
feeling. I haven’t noticed this addressed in any letters to
the editor or articles.
Helen Boreski, Caregiver
San Jacinto, California
Editor’s Note: You may want to find out more about
thalamic pain (also known as Central Pain Syndrome).
We published an extensive article in the September/
October 2003 issue that is now available online, at
strokeassociation.org/scmagazine, or call 1-888-4STROKE (888-478-7653). You may also want to visit
centralpain.org for more information.
After her stroke in 2005,
my wife
needed to get up three and four times during the night
to use a commode or be helped into an adjoining
bathroom. For several months we paid sitters to help her
at night so I could get enough sleep. Then one day we
rearranged our bedroom so the bed became an island,
close to the wall on her side. We had a short grab-bar
put on that wall.
Since then she has been able to get her feet over
the side of the bed, pull herself up onto her “good”
foot and pivot onto the bedside commode. She can
reverse these motions to get back into bed. The
distance to the bathroom is much shorter on those
occasions when she needs my help. We eliminated the
cost of nighttime sitters, and the island arrangement
has also made it easier for both of us to move around
the room during the day.
John Baker, Caregiver
Canton, Ohio
Please send to:
American Stroke Association
Planned Giving Department
7272 Greenville Avenue
Dallas, TX 75231-4596
When the time comes for
c
Please send me the free booklet
When the Time Comes. (CCA)
c
Please have a representative contact me to
discuss how charitable estate planning can
benefit me. (CCD)
I am considering a gift to the American Stroke
Association through my estate plan. (CCC)
I have already included the American Stroke
Association in my will/estate plan. (CCB)
one of you to carry on.
c
Every thoughtful husband and wife knows the time
eventually will come when one of them will have to carry
on alone, and perhaps spend many years as a widow
or widower. The American Stroke Association has
prepared a practical, supportive brochure to help spouses
prepare for life without their marriage partner. It will help
you be ready “when the time comes” not only to handle
the details and decisions that follow a spouse’s death, but
also to deal with financial and practical matters – in short,
to resume life as effectively as possible.
For more information, please visit us at
strokeassociation.org/plannedgiving or e-mail us at
[email protected].
c
Name
Address
City
State
ZIP
Phone
Birthdate
07EPGBA
E-mail
IAD SC 11/06
LS-1091 ©2006, American Heart Association
4
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S T R O K E
C o n n e c t i n g Yo u t o t h e Wo r l d
Neurons Grown from Embryonic Stem
Cells Restore Function in Paralyzed Rats
F
or the first time, researchers have enticed
transplants of embryonic stem cellderived motor neurons in the spinal cord
to connect with muscles and partially
restore function in paralyzed animals.
The researchers used a combination
of transplanted motor neurons, chemicals
capable of overcoming signals that
inhibit axon growth, and a nerve growth factor to attract
axons to muscles. Axons are the fibers that carry impulses
away from nerve cells and to the synapse. The report was
published in the July 2006 issue of Annals of Neurology.
“This work is a remarkable advance that can help us
understand how stem cells might be used to treat injuries
and disease and begin to fulfill their great promise. The
successful demonstration of functional restoration is proof
of the principle and an important step forward. We must
remember, however, that we still have a great distance
to go,” said Elias A. Zerhouni, director of the National
Institutes of Health.
“This study provides a ‘recipe’ for using stem cells
to reconnect the nervous system,” said lead author
Dr. Douglas Kerr, M.D., Ph.D., of the Johns Hopkins
University School of Medicine. “It raises the notion that we
can eventually achieve this in humans, although we have a
long way to go.”
In the study, Dr. Kerr and his colleagues cultured
embryonic stem cells from mice with chemicals that
8
caused them to differentiate into motor neurons. Just before
transplantation, they added three nerve growth factors to
the culture medium.
The cells were transplanted into eight groups
of paralyzed rats. Each group received a different
combination of treatments using different drugs and
growth factors. Three months after the transplants, the
investigators examined the rats for signs that the stem
cell-derived neurons had survived and integrated with the
nervous system.
The rats that received the full cocktail of treatments had
several hundred transplant-derived axons extending into the
peripheral nervous system, more than in any other group.
The axons in these animals reached all the way to a muscle
in the lower leg and formed functional connections, called
synapses, with the muscle.
The rats showed an increase in the number of
functioning motor neurons and an approximately 50 percent
improvement in hind limb grip strength by four months
after transplantation. In contrast, none of the rats given other
combinations of treatments recovered lost function.
Previous studies have shown that stem cells can halt
spinal motor neuron degeneration and restore function
in animals with spinal cord injury or ALS. However, this
study is the first to show that transplanted neurons can
form functional connections with the adult mammalian
nervous system. They used both electrophysiological and
behavioral studies to verify that the recovery was due to
connections between the peripheral nervous system and
the transplanted neurons.
“We’ve previously shown that stem cells can protect
at-risk neurons, but in ongoing neurodegenerative diseases,
there is a very small window of time to do so. After
that, there is nothing left to protect,” said Dr. Kerr. “To
overcome the loss of function, we need to actually replace
lost neurons.”
While these results are promising, much work remains
before a similar strategy could be tried in humans. The
therapy must first be tested in larger animals to determine if
the nerves can reconnect over longer distances and to make
sure the treatments are safe. Researchers also need to test
human embryonic stem cells to learn if they will work in
the same way as the mouse cells. It has only recently
become possible to grow motor neurons from human
embryonic stem cells.
S T R O K E
C o n n e c t i n g Yo u t o t h e Wo r l d
Congress Urged to Pass STOP Stroke Act
T
he American Stroke Association and its You’re the Cure advocates
continue to encourage Congress to enact the Stroke Treatment and
Ongoing Prevention (STOP Stroke) Act. The STOP Stroke Act will
improve stroke care by helping ensure that stroke is more widely
recognized by the public and more effectively treated by healthcare providers.
This legislation was re-introduced in the 109th Congress by Sens. Thad Cochran
(R-Miss.) and Edward M. Kennedy (D-Mass.) and Reps. Chip Pickering
(R-Miss.) and Lois Capps (D-Calif.). The bill has more than 140 co-sponsors in
the House of Representatives and about 24 co-sponsors in the Senate.
Time is running short, but proponents remain hopeful that the 109th
Congress will act on the STOP Stroke Act before it adjourns this year. In the
Senate, the Committee on Health, Education, Labor, and Pensions, which has
jurisdiction over the bill, has been conducting meetings to discuss moving the
legislation forward. In the House, the bill awaits consideration by the Energy
and Commerce Committee.
For information about the STOP Stroke Act and its status, please visit
StrokeAssociation.org and type STOP Stroke Act in the Search box or go
directly to the information by typing the following URL into your browser:
http://www.americanheart.org/presenter.jhtml?identifier=3010937.
Mild Heart Impairment Linked to Stroke Risk
M
ild, often symptomless,
impaired heart function
may predispose a person
to ischemic stroke,
investigators report in Stroke: Journal
of the American Heart Association.
Having any degree of impaired
heart function, known as left ventricular
dysfunction (LVD), was almost five
times more common in stroke patients
than age-matched controls.
Although previous studies have
linked heart failure to increased stroke
risk, this is the first evidence that
even mildly impaired heart function
may be an independent risk factor
for ischemic stroke. The finding
raises the question of whether LVD
should be included in the evaluation
of a person’s stroke risk. Mild,
symptomless LVD is present in 3
percent to 6 percent of the general
population, according to this study.
In LVD, the heart fails to pump
blood as effectively as a normal-
10
functioning heart. Associations
between impaired heart function and
stroke have come primarily from
studies of patients who survived
heart attacks. The association
between LVD and stroke in the
general population had not been as
clearly evaluated in any large studies.
The analysis focused on 558
Northern Manhattan Study (NOMAS)
participants. There were 270 stroke
patients with first-time ischemic
stroke and 288 stroke-free participants
who were matched with the patients
according to age, gender and ethnicity
or race. Using echocardiography,
researchers documented LVD in 24.1
percent of stroke patients and 4.9
percent of the control group.
LVD of any degree increased the
odds of stroke more than three-fold in
men and patients under age 70, and
almost five-fold in women and patients
70 and older. The link was detected in
all ethnicities.
The study also poses a treatmentrelated dilemma: what to do after
diagnosing LVD. The authors
emphasized that further studies are
required to assess whether drug
treatment could lessen the chance of
stroke associated with LVD. How
LVD increases ischemic stroke risk is
unclear.
Relaxing the Unaffected
Brain May Help Recovery
S
lowing activity on the side
of the brain undamaged in
a stroke may safely restore
lasting motor function,
according to a small study in Stroke:
Journal of the American Heart
Association.
Researchers found that decreasing
neural activity on the unaffected brain
hemisphere with a session of repetitive
transcranial magnetic stimulation
(rTMS) significantly improved stroke
survivors’ motor function for a short
time. The mechanism of this brain
stimulation might work similarly to
that of constraint-induced therapy in
which a survivor’s healthy limb is
restrained to force the stroke-affected
limb to function.
Here, rTMS decreases neural
activity on the healthy hemisphere
of the brain, which forces the strokeaffected hemisphere to be more
active. Thus, this treatment might
be considered a kind of constraint-
induced therapy for the brain.
Of 15 stroke patients (11 men,
average age 56) who’d had a stroke at
least a year earlier, 10 were randomly
assigned to receive active rTMS
and five to receive inactive (sham)
rTMS. Stimulation to relax neural
activity was applied to the primary
motor cortex area in the hemisphere
unaffected by stroke.
Researchers evaluated movement
in patients’ affected and unaffected
arms with a series of simple
movement and reaction tests. They
found that the active rTMS improved
motor function only in the affected
hand. For instance, in a reaction-time
task, patients averaged 30 percent
faster than baseline after five days of
treatment, and that effect lasted for
two weeks.
Interestingly, the improvement
was cumulative: Patients were on
average 10 percent, 20 percent, 27
percent and 30 percent faster on days
two, three, four and five, respectively.
Researchers speculate that
this therapy may help overcome
“learned non-use” of the strokeaffected limb. The daily inhibition
of the unaffected, healthy brain
hemisphere for five consecutive days
may mimic the effects of prolonged
constraint-induced therapy and
induce similar changes in the brain.
They also suggest that combining
constraint-induced therapy and rTMS
stimulation may further enhance
motor function recovery.
To learn more about rTMS, read
“New Directions in Rehab” in the
July/August 2006 issue.
National Family Caregivers Month 2006
he National Caregivers
Association’s Caring Everyday
Campaign acknowledges the
one in five American adults who serve
as family caregivers. As stroke families
know, caregiving is an important and
time-consuming part of daily life.
Unfortunately the burdens and stress that
are a part of family caregiving can take
their toll. Family caregivers are known to
have much higher rates of depression
than the rest of the population.
There will be a special emphasis
this year on the need for all of us to
help family caregivers protect their
health so they can have a more
T
satisfying life and be better able to
provide their loved one with the best
care possible.
The NFCA Web site provides easy
access to information and ideas. They
have added a special Prescription
Assistance section to provide
information about the new Medicare
drug benefits with links to helpful
decision-making tools.
The campaign is sponsored by
Novartis, Eisai Inc., AstraZeneca,
To order a Family Caregiver
Forest Pharmaceuticals Inc.,
Kit and participate in National Family
Invacare, Adventist HealthCare,
Caregivers Month (November) 2006,
MetLife Foundation, Serono Inc.
call 1-800-896-3650 or visit
and GlaxoSmithKline Inc.
www.thefamilycaregiver.org.
11
READERS
C o n n e c t i n g Yo u t o O t h e r s
What Aphasia Has Taught Me
Chuck Hofvander on his tricycle
I
awoke in Milwaukee and thought, “I wonder
how I got here?” I was confused and not in
Milwaukee at all. It took several days to realize
that I had had a stroke.
When I regained my senses, I accepted that
I could not walk or use my right arm, but I was
confused because no one could understand
my speech. I had prided myself on my ability
to communicate, but now no one could
understand me.
Before the stroke at age 52 I had worked in senior-level
positions for many years. I had a wife, Liz, two sons ages
17 and 20, and a house in the suburbs. I rode my bike an
average of 2,500 miles per year. I was happy.
To paraphrase a line from The Wizard of Oz, “It’s not
how you love, but how much you are loved by others.” That
fits me to a tee, but it took the stroke for me to realize it.
I received hundreds of letters, cards and e-mails. They are
still coming, and it’s been almost two years.
I learned that “aphasia” had no known cure. I just
had to learn to live with it. That was devastating news
because it meant I was locked inside this big body and
unable to communicate.
Through hard work and perseverance, I have improved a
great deal. However, I’m not nearly back to the way I was
and that is frustrating. I can “think it” but cannot “say it” or
“read it” or “write it.” My mind has a will of its own.
Aphasia does not affect intellect, and that can lead to
a very frustrating misperception. Because people with
12
aphasia speak haltingly or not at all, others often assume
they are mentally ill or challenged. It is a heartbreaking and
devastating disability. I know this because of the difficulty I
have communicating with my sons.
But my aphasia also has a bright side. For instance,
I have made several friends that I would not have made
otherwise: Len, Mary Lou, Barry, Dick, Janet, Mike
and others too numerous to mention. I truly value their
friendship.
My relationship with these new friends is substantially
different from the friends I made before I had aphasia.
My new friends understand what it’s like to have this
disability. I am somewhat uncomfortable with someone
who has not had aphasia because they do not know
what it’s like to struggle with every word you speak.
With those who share the same disorder, I feel there is a
common bond between us.
As I mentioned earlier, I was into bicycle riding in a big
way. A couple of years ago, my cycling buddies bought
me a high performance
tricycle. Last summer,
I rode over 1,000 miles
and plan to do more this
coming year. When I’m
riding, I feel free, like I
never had a stroke at all.
I’m learning to
live with my aphasia,
but it frustrates me,
nonetheless. I’m learning
to accept that I will never
get back to the way I
was, but I can’t give
up or let my disability
get me down. In many
ways, the stroke was a blessing: I’ve made new friends,
reaffirmed some old ones, gotten closer to my wife and
children, and gotten more introspective.
All this has taught me several things:
1. I don’t worry about the little things. Before the stroke,
nothing was too small for me to worry about, but not
anymore.
2. I don’t fear death. Now that I’ve been near death, it
doesn’t scare me at all.
3. I enjoy life. It is precious.
Chuck Hofvander • Prospect Heights, Illinois
READERS
C o n n e c t i n g Yo u t o O t h e r s
‘Please Hand Me My Arm’
David and Charlotte Layton
C
harlotte, my bride of 38 years, has been my
sunshine and strength through this stroke
experience. She was not with me when
my stroke paralyzed my left side six years
ago, but she has been right by my side ever
since. Neither of us had a clue as to what was involved in
coping with the losses from stroke, so it has been a learnas-we-go experience.
We are both retired now, but retirement because of
stroke is not exactly how either of us had planned spending
our senior years. Stroke is certainly no laughing matter, but
keeping our sense of humor has made our journey much
easier. We are both grateful for my abilities rather than
saddened by my disabilities.
I have had to accept that there are things that I cannot
do alone and that occasionally I need assistance. This has
been especially difficult for me because I have always been
very independent and able to do whatever I tried. Asking
for help can be very humbling and especially difficult for
someone as independent as I have been most of my life.
Charlotte has pointed out that “obnoxiously independent” is
a better description. As I said, keeping a sense of humor has
helped us through the journey.
I realized I needed assistance in keeping my affected
arm in close proximity to my body when turning over in
bed at night. As I turned onto my right side after lying on
my back, my left arm would remain on the bed as my body
turned away from it. If I roll back over to retrieve my left
arm with my right arm, I roll over top of the left. Hence,
it has become a common request in our bedroom at night,
“Charlotte, please hand me my arm.”
She graciously complies and puts that big, heavy,
left arm on top my left side where I can control it with
14
my right. This is just a physical example of why it is so
important to me that she has stayed close by my side.
Much more important than the physical assistance is
the cheerful attitude she has kept on our journey sailing
through this storm called stroke. I consider myself a very
lucky man to have been married to such a caring, wonderful
wife over the past 38 years.
Without adequate sunshine, especially in the winter
months, our bodies have chemical changes that cause
depression and despair. My bride has been my sunshine,
giving me the strength and courage to do battle with this
stroke. Because of her love and encouragement, we have
turned disabilities into accomplishments. With God as our
Captain, and Charlotte as my crew, I know we will sail
safely through this storm. As long as I have my sunshine,
I will survive. Thank you, Lord, for sending her my way.
David Layton, Survivor
Greensboro, North Carolina
A Prayer for Caregivers
Please send help God, won’t you hurry,
To comfort those who are filled with worry.
Their long days are spent caring for others —
Husbands, wives, sons, daughters or mothers.
Loved ones with stroke, helplessly stricken,
Or other illness that has made them a victim.
Give them some free time; refresh them anew.
Bless and send strength for all that they do.
For each loving person
we thank you so much,
For care-giving “angels”
with life-giving touch.
Audrey Collins, Survivor
Hutchinson, Kansas
Audrey Collins
TWO WHO WON’T GIVE UP
George and Rose Carpenter
experienced a hemorrhagic stroke in October 2001 at age 80. It left my entire
left side paralyzed. After a month in the hospital, I was told I might never walk
again and left there in a wheelchair. My lovely wife Rose is my caregiver, and she
refused to accept that prognosis.
For three years, she encouraged me to participate in physical therapy
three times a week. She also signed me up for water therapy. There she is
in the water with me. She also does exercises with me at home.
Because of all this work, I am able to walk without a cane, with Rose
at my side. Also I can shower, shave and dress without assistance,
although she has to apply deodorant to my right arm pit. I never regained
the full use of my left arm: I can raise the shoulder and upper arm, but I’m
unable to use my hand at this time.
Still refusing to give up, Rose encouraged me to find a mall that had
a walking program. We joined and go every day except Sunday. With her by my side, I use a
cane and walk the entire mall, plus climbing up and down stairs. On the lower level, she helps
by holding my belt loops, walking sideways and backwards. This past year I have been able
to walk beside the upper railing without a cane or Rose holding on.
The people in the mall stop and encourage us and tell us we are an inspiration to all that
have had strokes. It’s been almost five years, and I am still improving my lifestyle because my
wife refuses to give up, even though she had her gall bladder removed and has had some
heart problems during this time.
I hope our story gives others the will to keep trying, never give up!
George Carpenter, Survivor • Vancouver, Washington
Lady and Me
F
or several days I heard the dog barking on
the path of a rabbit. They were huge barks,
as if it were a big dog, but when I asked,
my grandson Billy Ray said, “On no, she’s a
puppy, a little dog that my father-in-law had
before she was hit by a car and crippled up. The vet did
the best he could for her, but she is really crippled, so he
let me keep her, but she is bad crippled.”
They named her Lady.
I couldn’t believe her chasing rabbits all day. And that
bark — so big and resounding! Just like a huge dog.
But when I went walking she came up to me and I saw
how little she was, just half grown up. So small, and so
crippled, with her back caved in and her right leg dragging.
I thought, “Lord, she can’t make it through the winter.” But
she did, hunting every day. By spring, she was strong and
fat, but still crippled. How could she do that?
Then I remembered me, how I had tried to walk after
my stroke five years ago when I was 72. I remembered
learning to walk again. I remembered how I took
everything everybody said and made them liars. Oh yes,
I remember!
Grace Henry and Lady
Now five years hence, I can do everything I want
to do. I can drive, I can talk (a little), I can take care
of myself, and I can “bark and chase rabbits all day,”
just like the puppy. We are alike, Lady and me. We are
survivors, that little crippled puppy and me. Yes, we are
survivors, with God’s help, we are survivors, and we’re
doing very well.
Grace Henry, Survivor
Greenville, Kentucky
15
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DOCTOR’S APPT.
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NAIL APPT.
Spring Summ
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Date:
SWIM
Date:
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Weight
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DATE NIGHT
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* To calculate your
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7ITHTHE,INGRAPHICA%XPRESS
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visit www.Am
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Know...
THE WARNING SIGNS
OF STROKE:
• Sudden numbness or weakness
of the face, arm or leg, especially
on one side of the body
• Sudden confusion, trouble
speaking or understanding
• Sudden trouble seeing in one
or both eyes
• Sudden trouble walking,
dizziness, loss of balance or
coordination
• Sudden, severe headache with
no known cause
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If so, you may be eligible to participate in this interesting
clinical research trial! Researchers at the Mayo Clinic are
looking for additional families to participate in the Siblings
With Ischemic Stroke Study (SWISS). SWISS is a National
Institutes of Health funded clinical study to discover inherited
risk factors for stroke. There are nearly 50 centers enrolling participants across North America. To learn more about
SWISS or to find a center near you to participate...
Please contact Alexa Richie
[email protected]
More information is also
available on the NIH site
XXXDMJOJDBMUSJBMTHPW
keywords ‘Sibling and Stroke’.
16
Do sudden, unpredictable emotional
outbursts disrupt your life?
You are not alone.
You may be one of more than a million Americans suffering from
involuntary emotional expression disorder (IEED).
Involuntary emotional expression disorder can
happen when disease or injury damages the area
of the brain that controls how you express your
emotions. The result: sudden, unpredictable crying,
laughing, or other emotional episodes that can be
disruptive and embarrassing.
But you are not alone. More than a million people
diagnosed with neurologic disease or injury also
have IEED—impacting their lives, and the lives of
those close to them.
If you or someone you care for experiences these
episodes and has been diagnosed with a condition
such as multiple sclerosis (MS), Lou Gehrig’s
disease (ALS), Parkinson’s disease, Alzheimer’s
disease, stroke, or traumatic brain injury, it may be
due to “short circuits” in brain signaling. It may not
be depression. And you can begin to take control.
To learn more about IEED, visit us at www.IEED.org
or call 1-866-932-3411.
Ask your doctor about
To learn more, visit us at www.IEED.org or call 1-866-932-3411
©2006 Avanir Pharmaceuticals.
All rights reserved.
NX0036ADV0607
What
I can
Do
by William Janson, Survivor
Willingboro, New Jersey
O
ur story begins on
April 2, 1986. My wife
Charlotte and I are in
the 22nd month of our
honeymoon. We are
still in love. We are both working
every day. I am a union construction
electrician; Charlotte is an insurance
William Janson at home in New Jersey
underwriter working in downtown
Philadelphia. Charlotte takes the bus to work. It is cheaper and more convenient due to
the limited and expensive parking in the city. I drive to work because I need to carry
many tools. Besides, I can deduct the cost of transportation from my taxes. I am 41.
Charlotte jokes about me cooking dinner and having it ready when she gets home.
She is a vegetarian. I like meat and potatoes. I tell her “cooking is woman’s work,” and
she agrees. She cooks for me every night when she gets home.
This night we are having spaghetti. Charlotte isn’t really good at measuring spaghetti
and cooks too much. Not to waste any, she piles it on my plate till it is filled to
overflowing. She says, “Just eat what you want.” I like spaghetti and work hard at eating
most of it. I have a beer with dinner — another wonderful evening in our little love nest.
My sister has been coming over to our apartment in Lumberton, N.J., to discuss the
Bible with us. This night she brings her daughter. We discuss the Bible for about an
hour. I walk them down the steps from our second-floor apartment and watch as they
drive away.
That’s the last thing I remember about that evening and most of the next 46 days.
Charlotte has to explain it to me.
We straighten up the apartment and prepare for bed. We are two lovebirds, so we go to
bed and make passionate love. I use the bathroom, and on my return to the bedroom I am
holding the back of my neck and complaining of a headache. I have always been extremely
pain-tolerant, but I tell her that the pain is getting really bad and she should call someone.
18
I lie on the bed, and Charlotte goes to
get things ready for the next day. When she
comes back, I am still lying down, and she
thinks I’ve fallen asleep. Suddenly I sit bolt
upright and start vomiting uncontrollably.
This is before 9-1-1 came to our area, and
Charlotte can’t remember the name of the
nearby hospital. She calls my sister to get the
name and then calls information to get the
phone number. Finally, she calls the hospital,
and they dispatch an ambulance to our
apartment. In the short time it takes to put
underwear on me, they are knocking at the
door. The police arrive along with the EMTs.
I am still vomiting and can’t be
transported until I stop. Charlotte has to
answer a lot of questions like “does he do
drugs?” and “did he hurt his head?”
could only be reached by going into my ventricle, the
part of the brain that is like a cavern. I was released
from the hospital nine days later. I lost the upper-left
quadrant of the vision in both eyes. My balance was
really bad. I had seizures. My cognition was (and still
is) less than stellar.
My seizures were controllable. My vision loss didn’t
present any real problems other than maybe bumping
my head more than usual. I had a short course of
rehabilitation and returned to work seven months, one
week and two days after the hemorrhage. I finished out
my career as a construction electrician, and because of
colon cancer and a workplace accident, I retired on July
1, 2001, at the age of 56. That gave me more time to
devote to brain injury ventures.
I joined a support group for AVM survivors as well
as another group for people who have had brain injuries.
Then I joined a second support group for brain-injured
“That’s the last thing I remember about
that evening and most of the next 46 days.
Charlotte has to explain it to me.”
The squad is working on me even
though I am still vomiting. They are getting
covered. The spaghetti becomes clogged
in my airway. Fortunately, the paramedic
has forceps. They break the rules and use
the forceps to dislodge the spaghetti in my throat. I stop
vomiting, but not before I fill my lungs. I can now be
transported to the hospital.
How did this happen? Apparently, I had a congenital
defect in my brain called an arteriovenous malformation
(AVM). When my blood pressure increased, it
hemorrhaged, filling my head with blood. By the time I
arrived at the hospital, the blood was coming out of my
mouth, nose and ears and puddling in my eye sockets.
I wasn’t responding to any stimuli. I was convulsing
and went into a coma. I even stopped breathing and for
almost a week I had to be put on a respirator.
The initial diagnosis was a ruptured berry aneurysm,
and I wasn’t expected to live through the night. The
diagnosis was changed to a hemorrhage of the AVM. I
needed surgery. Due to the large volume of blood in my
skull, the surgery had to be postponed until the blood
reabsorbed. That took 37 days.
A craniotomy was performed and the AVM removed.
It was deep into the white structures of my brain and
people. It doesn’t matter how you sustain a brain injury,
whether a stroke or traumatic brain injury or a tumor,
you get the same kinds of deficits. My hemorrhage is
considered a stroke, so I joined a stroke support group.
Then I joined another stroke support group. I regularly
attend seven brain-related support group meetings every
month. I have learned a lot about brain injury.
Charlotte asked
me why I go to all of
these meetings, and I
said, “Because I
can.” Here’s what I
can do at these
meetings: I can
encourage, I can
validate, I can give
hope, I can inspire,
I can teach, I can
learn. I have already
learned a lot, but I
can still learn more.
I go to one meeting
and learn something, then I take it to the next meeting
and the next and the next. I improve my situation while
helping others. What can be better than that?
19
20
A Young
Mother’s
Stroke
by Kelly Mauk, Survivor
Chanute, Kansas
life changed drastically in the
early morning of Nov. 10, 2000.
I was just 35 years old, the
mother of a 4½-year-old son and
a week-old daughter. I had been teaching for 11 years
and was on maternity leave from school, but I had a
project that I needed to work on for my superintendent.
That afternoon, I went to school to get the materials to
complete the project at home.
I was experiencing the worst headache I had ever had.
The pain in my lower neck was excruciating. I assumed it
was the aftermath of the spinal I’d had during childbirth. I
remembered a casual conversation I’d once had with a lady
who mentioned that when she was given a spinal before
giving birth, it was accompanied with a bad headache
afterward. I knew it was a long period of time for a residual
headache to occur, but I just excused it with that cause.
The headache persisted all through the evening. I
couldn’t explain it. My husband David said he would
make me an appointment with the chiropractor the next
morning, thinking maybe I had a strained muscle in my
neck. I talked to my mother on the phone before I went
to bed. She told me to go to the hospital if it got too
bad. I passed that off as the advice of an overprotective
mother. I got the kids in bed, and then I went to bed
myself, feeling very weary.
I awoke around one o’clock, shaking and trembling
immensely. I was also crying (or what I perceived to
be crying) uncontrollably. Meantime, David woke up
and asked what was wrong. I couldn’t say anything. I
wanted desperately to tell him that I didn’t know, but that
something was terribly, terribly wrong. However, words
would not come.
I had to get away from the mental torture that was
happening to me when I could not verbalize my feelings.
But when I got up to move to the couch, I got another
shock — my leg was numb! Paralyzed, literally, with my
right leg and arm, and paralyzed, figuratively, with fear, I
somehow managed to reach the couch. I lay on the sofa
and sobbed, wishing it was all a hellish nightmare. David
came in and, I’m sure, in a state of bewilderment, gave me
the inquisition of my life.
“What’s wrong?”
“Do you want a couple of aspirin?”
“Is it your head?”
“Are you all right?”
“Do you want to go to the hospital?”
“Yes, yes, yes,” I thought. In my mind, I was figuring
out what was going on – I was having a stroke. The loss of
speech was the dead giveaway. I wanted to shout, “Please
take me to the hospital. Hurry!” Anyway, after what
seemed to me like hours, in reality probably a few minutes,
David called his mom and she came to watch the kids
while we went to the hospital.
After examination, the doctor diagnosed a stroke. I
had hemorrhaged in the brain, and it was in an operable
position. I was life-flighted to Wichita, to a larger hospital
with neurologists on staff. The doctors there prepped me
for surgery, and we waited and waited… and waited. We
were waiting for my family, my mother and father, to drive
there and see me before the doctor would operate, but it
was a two-hour drive! It seemed an eternity.
I overheard a nurse say they were coming to say
their goodbyes. I later learned I had only a 20 percent
chance of living.
(continued)
21
I survived surgery and was met with a very warm
and much-needed reception of family members. I still
couldn’t speak, my eyesight was blurred, my head
was half-shaved, and I was paralyzed on the whole
right side of my body, but I WAS ALIVE!
I never once doubted the power of God in this
miracle. I do not know why, but I had an inner
peace throughout this entire ordeal. It was as if God
had taken hold of my soul and wrapped me in his
arms. There was a sense of serenity in my being. I
knew with all my heart that He was with me. It was
unquestionable: He was there!
The hardest part was lying in that bed after
surgery and pondering what Dawson, my son,
would be thinking. His entire world had come
crashing in on him. I know kids are resilient, but
he was my life. I had hardly been away from him
in all his four years. We were inseparable. We
were kindred spirits. I needed to see him. I needed
to know that he was all right. How could he ever
understand what was happening to him when I
couldn’t speak to him?
Dawson had often used my long hair
as his security blanket at night ... but on
that night I don’t think he ever really
believed that I was his mommy.
My dad brought him to the hospital after a couple
of days. He had been told only that mommy had a bad
headache and was in the hospital. I will never forget
his reaction of fear and shock when they held him near
my bed to have a reunion with his mommy. “That’s not
Mommy!” he said, as he shied away from the stranger
that lay in the hospital bed.
I can only imagine his shock to find a shell of a woman
with a half-shaved head and a face that sagged on one side
when he was expecting to find his mother. Dawson had
often used my long hair as his security blanket at night
when he would go to sleep. Everyone tried to do a lot of
convincing, but on that night I don’t think he ever really
believed that I was his mommy. With a lot of help from
God, he finally accepted me as his mom and in the months
ahead we rebuilt our cherished relationship.
Morgan, my infant daughter, also concerned me, but I
knew she would be all right. I had only been her mother
for seven days prior to the stroke. She was in good hands
22
and would know no
difference.
I had physical and
speech therapy in the
week I remained in
the Wichita hospital.
Then I transferred
to the Kansas
Rehabilitation Center
in Kansas City, where
I stayed for about six
weeks. This is where
much emotional
upheaval took place.
The realization of all
the things I couldn’t
do was overwhelming!
All those precious
movements I had taken for granted now lay dormant.
I wouldn’t give up. There was too much at stake,
namely reclaiming life with my kids. They needed me. I
needed them.
With God holding my hand through it all, we fought a
mighty battle. There was a lot of hard work, perseverance
and praying, plus a number of skilled and compassionate
therapists, and the steadfast love of my family members,
especially my husband and my mother. David was my
rock. He stayed with me at rehab and encouraged me
through therapy.
It wasn’t easy, but I have recaptured my life and my
bodily movements. I am teaching again. My only deficit is
the fine motor coordination in my right hand. Sometimes
it’s a nuisance, but I think of it as my connection with God,
my little reminder of what was … and what now is.
It is a secret between the Almighty and me. It seems to
whisper, “Call upon me for strength. I will never fail you.”
I can always find
solace in Psalms 23:
“Yea, though I walk
through the valley
of the shadow of
death, I will fear no
evil, for thou art
with me.”
Photos, clockwise
from left: Kelly Mauk;
Morgan Mauk;
Dawson Mauk; David
and Kelly Mauk
at home with their
children.
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23
F E AT U R E
24
egotiating
Hope
p and
cceptance
by Jon Caswell
ust as no two strokes are alike, no two
stroke families are the same. How families
handle strokes can range from complete
denial to meticulous micromanagement
of every medical, financial and emotional
detail. And how families respond to longterm, possibly disabling illness can affect
the survivor’s outcome because it can affect
how they see themselves.
“People cope best when they have a sense of control over
their lives,” says psychologist Barry J. Jacobs, Psy.D., author
of The Emotional Survival Guide for Caregivers. Their ideas
about this control often define how patients and family members
react to a stroke. “Some individuals believe knowledge is power,
a way to control their future health. These individuals scour
the Internet, join chat rooms, compare opinions and uncover
alternative remedies.
“Other people find knowledge disempowering,” says Dr.
Jacobs, who is the director of behavioral sciences for the
Crozer-Keystone Family Medicine Residency Program in
Springfield, Penn. “They feel stripped of control of the outcome
when they receive definitive medical pronouncements. When
they try to shield themselves from ‘bad news’ or simply reject it,
we call it ‘denial.’”
Minimization is another strategy often witnessed in people who
don’t think knowledge is power: “I know I’ve had a stroke, but it’s not
that serious. These drugs, this rehab, that doctor will do the trick.”
(continued)
25
F E AT U R E
Information and
Partnership
In a condition as serious as stroke, the flow of medical
information plays a large role in the sense of control and
well-being of both patients and family members. “Because
of this, doctors are often treated like potential adversaries
— either squeezed for information or kept at arm’s length
to deflect what they say,” Dr. Jacobs says. “Doctors
commonly complain that they are often treated as part
of the health problem. In addition, different doctors feel
differently about whether to share everything or just give
the Cliff Notes version. Some have qualms about sharing
information with relatives.”
Though this has changed over
the years, the ideal physicianpatient relationship described in
modern textbooks is defined as
partnership. “This partnership
can become strained if there are
mismatches in communication
styles or information-sharing
preferences between patients
and physicians,” says Dr. Jacobs.
“For instance, a frightened
patient and a close-to-the-vest
physician may not mix well, nor
would a mistrustful patient and
Dr. Barry Jacobs
a bold neurologist be a good
match.” When the personalities of specific family members
are factored in — say, a relative who readily shares
uninformed and unsolicited opinions — the partnership can
become even more strained.
“When the partnership breaks down, the patient’s
prognosis is often one of the main areas of disagreement,”
says Dr. Jacobs. “The stakes are high because few things
affect our sense of control more than our health and the
illness that compromises it.” Healthcare professionals,
with broader scientific knowledge and clinical experience,
often take a more circumspect view of possible outcomes
than patients and families. The doctors would call their
perspective realistic, while a family might feel it was
too pessimistic, not giving enough weight to intangible,
metaphysical aspects of healing. Family members are more
likely to view things in terms of will to live, the hand of
God, and the healing power of family and prayer.
“It’s difficult to tell which attitudes reflect reasonable
hope and which are sheer fantasy, well-intended but
pie-in-the-sky wishfulness,” says Dr. Jacobs. “And this
is important because hope is essential for keeping up a
patient’s morale.
26
“Not only do professionals, patients and family
members disagree on what to expect, among patients and
their relatives there are often sharp disagreements about
whose vision of the future should hold sway. For instance,
if one family member seems overly pessimistic, the
others may debate him vociferously. Or if someone is too
optimistic, then others may make comments to bring him
down to earth. As the illness drags on, the tension between
hope and fantasy often increases and becomes a major
stressor for everyone involved.”
It is common for patients and relatives to have different
perspectives on the patient’s situation. Some survivors may
accept their deficits as the price of moving on with their
lives, while family members may judge such acceptance
as resignation. Voicing that opinion may cause the patient
to feel that he or she isn’t doing enough. How can stroke
families navigate that passage between hope and wishful
thinking, acceptance and resignation?
The Power of
Positive Thinking
“‘The power of positive thinking’ is a commonly held
belief in our culture,” says Dr. Jacobs. “We talk about silver
linings, the dark before the dawn. The entire American
ethos of pushing into new frontiers is based on the idea that
we have within us the determination to face all challenges
and succeed.”
It turns out that there are benefits to that mindset,
which social psychologists Shelley Taylor and Jonathon
Brown call “positive illusions.” For two decades they
researched the impact of positive attitudes and beliefs.
“They concluded that when people believe in themselves
and their capabilities for dealing with difficult events,
regardless of their actual ability to handle them, they
cope much better overall,” says Dr. Jacobs. “In other
words, overrating yourself frequently helps. And
the opposite is also true, if you regard yourself less
positively and more ‘realistically,’ you may be less able
to cope and more prone to depression.
“Dr. Brown theorized that if you believe you’re
hot stuff, then you’re more likely to judge negative
circumstances as challenging rather than crushing. If
you believe you’ve got what it takes, you’ll take actions
with confidence rather than remain passive in fear. If you
confidently take action, you’ll feel greater control over
adverse situations and have less emotional distress.”
The past 20 years have seen the rise of a “positive
psychology” movement that has investigated the effect of
these positive attitudes and beliefs on how people react to
catastrophic events. One of the movement’s core findings is
that when people are raised to be optimistic — that is,
they hold on to positive beliefs about the future even during
difficult periods — they contend better with life’s disasters
without becoming depressed. On the other hand, those who
develop pessimistic outlooks and self-blame stumble into
despair when the going gets tough.
Says Dr. Jacobs, “Applying the theories of positive
illusions and positive psychology, we can surmise that
believing that you’re going to get better has advantages
over being consumed with anxiety about your fate.
Optimistic patients and families see complications as
bumps in the road, not the end of the line. If you’re a
caregiver, your faith that you’re fighting a winnable battle
may be a balm to your fatigue and self-sacrifice.”
Life-altering illness is a tough circumstance in which
to hold onto hope and optimism. While that attitude may
shield you from demoralizing news or give you faith that
the family will get through this, unmitigated optimism
can also be a blindfold. Optimism is not a panacea,
especially when it spills into denial. “No amount of
hope can negate reality,” says Dr. Jacobs. “Refusing to
accept the consequences of an illness is not a positive
achievement. In fact, that strategy often does more harm
than good in long-term psychological adjustment.”
Half-Full Is Better
How should stroke survivors and their families
weigh hope and acceptance, fantasy and reality? In The
Emotional Survival Guide for Caregivers, Dr. Jacobs uses
the metaphor of the glass of water — is it half-full or halfempty? — to investigate this question. Perceiving the glass
as three-quarters empty when it is actually half-full is a
distortion of reality commonly associated with depression.
“This belief will make an illness’s consequences feel more
painful and increase suffering,” says Dr. Jacobs.
Perceiving the glass as three-quarters full when it is
actually half-full is a distortion of reality often associated
with a Pollyanna attitude. “This attitude substitutes
naive belief for preparedness and makes any negative
developments or outcomes more shocking and hard to
adjust to. Both types of distortions should be guarded
against.”
Still, distortions aside, is optimism helpful or should
families and patients stick strictly to the clinical facts
presented by the medical professionals? “On this question
the research is clear: Half-full works better,” says Dr.
Jacobs. “Even stretching reality slightly, say to two-thirds
(continued)
27
F E AT U R E
full, is okay. Reasonably optimistic patients and caregivers
strive harder to find the best treatments, and they follow
them with more rigor once they’ve found them. Hope
carries them through rough patches. Staying positive
allows them to try new solutions when the old ones stop
producing results.”
But staying positive shouldn’t preclude feelings of
worry, anger or sadness. “Squelching those feelings
because they’re too ‘negative’ can be damaging in itself.
But those feelings shouldn’t undermine a basic belief
that things will work out in the end, that the illness will
be managed, and the family will endure. Patients and
caregivers and professionals should all be united to fight
the good fight. They should fight it believing they’ll
ultimately prevail. There’s nothing fancy or innovative
about this — most of us commonly refer to it as being
cautiously optimistic, with an emphasis on the cautious.”
Is it possible to find the balance called cautious
optimism? In his book, Dr. Jacobs identifies three areas for
caregivers to evaluate.
• Evaluate the medical situation as realistically as
possible; be aware of all that you know about the
stroke and the patient. Don’t emphasize or discount
either one.
28
• Endeavor to avoid the roller coaster of emotional
reactions to every new development in your loved
one’s condition. When they have a good day in
therapy, don’t conclude the end’s in sight. On the
other hand, if today’s prognosis is bad, don’t count the
survivor out.
• Take a longer, more dispassionate view. “Let time
pass, events unfold and emotions settle,” says Dr.
Jacobs. “You’ll be better positioned to assume
a stance that’s sensibly optimistic without being
willfully foolish.”
Hope and acceptance
— every survivor and every
caregiver negotiates this
passage in recovery of a life
after stroke. Perhaps, the
goal is to gain peace of mind,
but that rarely happens right
away. Fear and stubbornness
may play a big part in the
negotiations. For reasons
of her own, a caregiver
may choose not to accept
a prognosis and, thereby,
ignores serious warning signs.
Because he disagrees with a
doctor’s evaluation, a survivor
may refuse to comply with a
treatment regimen that will
reduce his risk of another
stroke. Denial of what’s
happening is not the same as
peace of mind about what is
to come.
“The families that I’ve
seen cope the best with
stroke over time,” says Dr.
Jacobs, “are those who view
the medical crisis as the beginning of the process of
recovery and not just the end of life as they’ve known it.
By pitching together, gathering information and nurturing
realistic hope, these family members retain some sense of
control in the midst of uncertainty. Sometimes, that’s all it
takes to help the patient feel supported and keep up his
morale. Often, it what’s necessary for the family as a
whole to draw upon its innate courage and resilience. That
makes a crucial difference to how caregivers and their ill
loved ones fare emotionally, regardless of the eventual
medical outcome.”
For more information on Dr. Jacob’s book, The Emotional
Survival Guide for Caregivers, turn to p. 42.
One Family’s Journey from Hope to Acceptance
Charlene Nassaney had a stroke at age 52, leaving
paralysis and global aphasia.
her with right-side paralysi
Ten years later, despite the paralysis and aphasia,
she has an active life filled
ed with family, church and
shopping. Today she is an accomplished seamstress,
doll maker, gourmet cook and licensed hairstylist.
David, her husband of 31 years, has created a Web
site chronicling her remarkable accomplishments:
www.charlenestrokesurvivor.com. We talked to him
about how they got their lives back.
“We went through a three
three-year grieving process.
In the beginning she had physical and speech
therapy,
hoped and felt that she would get
herapy, and we hop
better quickly. As the days ran into weeks, then
months, now years, I’m glad no one told me that
10 years later we would still be affected by this. We
probably would have quit.
“I am a counselor at our church in Santa Clarita,
California, so going through the grieving process was
on-the-job training for me. The first stage was shock
and denial. She thought she was normal, and yet we
couldn’t understand her, which only made her angry.
She thought there was something wrong with us.
“The second stage was anger, which she took out
on everyone who loved her. It was not pretty. She truly
hurt the ones she loved. I came very close to the end
of my rope, but God kept giving me a daily dose of
grace to tolerate another day until it got better.
“The third stage was bargaining. I suspected she
was trying to bargain with God that if she did such
and such a thing, He would heal her. But she finally
came to a point that she realized God is sovereign,
and He allowed the stroke to happen for a reason.
Her faith was challenged. It is easy to have faith
when all is well, but you really see how much faith
you have when tragedy strikes.
“Fourth, guilt. She wondered if she caused the
stroke by lifestyle and behavior, but none of the risk
factors applied. The doctors never pinpointed a cause.
The Nassaney family (David, standing, wearing dark jacket; Charlotte,
seated, holding a grandchild)
“The fifth stage was depression. Losing the
quality of life you once had can cause you to
wonder if life is really worth living anymore. Charlene
wanted to die, but her faith led her to realize that if
God wanted her dead, He would have taken her, so
she must still have a purpose for being here.
“Sixth, loneliness. Loneliness is hard to overcome
when you lose friends, your independence and the
ability to communicate deeply. Her faith in God and
hope in her future helped her break through.
“The seventh stage is acceptance, which came
when the seeds of faith sprouted in her heart, and
God allowed her to see the glass half-full, instead
of half-empty. She took control of her life, redefined
who she is, and re-established her self-worth.
“God has given us faith that she will speak again.
We met a man who was like her for 10 years, then all
of a sudden his brain ‘got it’ and he started speaking.
He told Charlene, ‘Never give up!’ That renewed our
hope. We will never stop believing there is hope.
“We believe in miracles. God has done so many
for us already. Plus she has ministered to so many in
her present condition, more than if she were normal.
Our lives are in God’s hands.”
29
have talked to many stroke survivors over the years, and I can’t think of
one who said, “I was really looking forward to having this stroke.” By the
same token, however, many of those survivors made satisfying lives despite
their setback. To some extent, their response was determined by the age of
the patient and the severity of the injury. And to some degree, a person’s
emotional resilience determines whether their life improves despite difficulties
or declines because of them.
“Emotional resilience is the ability to bounce back from adversity,”
said Dr. Peter Ubel, author of You’re Stronger than You Think — Tapping
into the Secrets of Emotionally Resilient People. In the book, Dr. Ubel
relates the stories of five people who have wrestled with serious illness
or disability, weaving their stories in with discussions of the scientific
understanding of emotional resilience. He shows that people systematically
underestimate their ability to bounce back: “People who encounter
adversity often discover, to their own surprise, that they are as happy, or
almost as happy, as they were before encountering the adversity. People
imagine that happiness is a matter of circumstance, when instead happiness
is what people make of their circumstances.”
30
Bouncing Back
Whether we see something as a challenge or an obstacle,
Dr. Ubel thinks human beings are hard-wired to deal
with adversity. “If you want to know what an emotionally
resilient person is like, you can probably start by looking in
the mirror,” he said. “In the face of adversity, most people
are able to find happiness again.”
Dr. Ubel, who is a professor of medicine at the University
of Michigan, spent five years studying the nature of human
resilience through experiences of thousands of people who
faced extreme medical setbacks. These cases ranged over
such circumstances as patients with terminal illnesses,
chronic disorders, remissions and life-altering circumstances.
What Ubel and his team of researchers found is that patients
remained strong in the face of adversity by drawing upon
their underlying emotional resources, focusing their lives on
meaningful goals and finding ways to contribute to others.
Flexibility is a key ingredient of resilience, in part because
it leads to adaptation. “When people confront adversity, those
who are able to shift their life goals, in response to their
circumstances, are usually happier than those who do not
shift their goals,” Dr. Ubel said. “Being flexible in the face of
adversity is part of emotional resilience.”
What Works
There are genetic and psychological ways of staying
strong in the face of challenging circumstances.
• Negative emotions demand attention — Our cognitive
functions go on red alert to find some way to cope
with pain and negative feelings. “Negative emotions
tend to focus people more than positive emotions,”
Dr. Ubel said. “When people feel bad about
something, they look for ways to get rid of the bad
feelings. That is why animals have emotions in the
first place — to motivate behavior. It’s nature’s way
of dealing with the difficult stuff.”
• Silver-lining thinking — Researchers have found that
people find creative ways to minimize emotional pain
by looking for silver linings in the darkest clouds.
I have heard from innumerable survivors how their
strokes taught them invaluable lessons, forming their
characters in unique and satisfying ways. Finding the
good in what is going on right now reflects spiritual
maturity and allows a survivor to move forward.
• Comparison thinking — Studies indicate that people
usually make the best of their circumstances by
comparing themselves to those who are worse off.
People seem to intuitively know how to lessen pain.
• Knowing is less stressful than not knowing — People
are not set up for uncertainty. In a study of people
undergoing HIV testing in the 1980s, a time when an
HIV diagnosis amounted to a death sentence, people
were happier after they received their test results than
they were while waiting for them, no matter what their
results were. “Uncertainty about the future causes the
body to suffer under high stress levels,” Dr. Ubel said.
• Social interaction reduces stress — Anyone who’s
been to a good stroke support group knows that
sharing with others makes life better. And it’s not just
receiving support that helps people adapt to their new
circumstances. Dr. Ubel contends that people benefit
more by being able to give support to people they love
or to causes they care about. “I tell patients I work
with who are struggling with difficult circumstances
to look for ways that they can contribute to other
people, something that will make them feel good about
themselves. I also remind caregivers that as important
and wonderful as it is that they are helping their loved
ones, they also need to look for a way to help their
loved ones give something back to them. Social support
is a two-way street!”
Nurture or Nature?
“The best evidence suggests that 50 percent of the
difference in happiness between one person and another
person is based on genetics,” Dr. Ubel said. “If you want
to be happy, and if you want to be resilient, then it helps
if you have chosen your parents wisely! Because genetics
influences our personalities, and our personalities shape how
we respond to adversity.”
If there is such a thing as a
r e s i l i e n t p e r s o n a l i t y, D r . U b e l
p i c k s o p t i m i s t s o v e r p e s s i m i s t s.
If there is such a thing as a resilient personality, Dr. Ubel
picks optimists over pessimists and extraverts over introverts.
“Social relationships help people respond to adversity. The
long-term survival of heart patients depends, in part, on their
social situations, with married people surviving longer than
those who live alone. Social engagement promotes health.
There’s no doubt about that.”
Nor is it just your longevity that improves. “There
was another finding established by these studies: People
in support groups are happier than others. When people
become sick, they feel better if they can talk about their
illness with other patients.”
(continued)
31
“ I n t i m e s o f a d v e r s i t y, i t i s i m p o r t a n t
to l o o k i n w a r d a n d d i s c o v e r w h a t i s
m o s t i m p o r t a n t i n yo u r l i f e , w h e t h e r
i t b e yo u r s p o u s e , yo u r G o d o r yo u r
d e s i r e to c h a n g e t h e w o r l d .”
Religion’s Role
Religious belief also plays a part in meeting challenges.
The effect religion or spirituality has is complex. For
starters, those who participate in religious communities
gain the benefit of social support when unfortunate
circumstances arise. Religious belief also boosts emotional
resilience because it can give meaning and purpose to
suffering. In addition, religion also provides prayer, and
with prayer, people in difficult circumstances can find peace
of mind. People who have a spiritual focus are better able
to avoid depression that accompanies disability and lifealtering illness.
“I believe that religious experiences make it easier for
people to find happiness and help people to summon their
emotional resilience,” Dr. Ubel said. “Religious people are
more likely to believe the world is just, and such beliefs
make it easier for people to overcome adversity. In times of
adversity, it is important to look inward and discover what is
most important in your life, whether it be your spouse, your
God or your desire to change the world.”
Bringing the Mind into It
Happiness often is a matter of interpretation, and so
often interpretation is a matter of perspective. “Before and
after” thinking is a good example of this. Dr. Ubel contends
that people facing challenges are better off if they can
avoid the trap of “everything was OK before the stroke” or
“everything has been awful since.”
“If people reminisce about all the good things in their
lives before they faced a stroke, they are likely to become
unhappy. They’ll be more bitter about what they have lost
and not be able to appreciate any good fortune.”
The way out of this is for people to embrace the positive
events from earlier in their lives, rather than bemoan those
events as part of their previous lives.
“Positive thinking leads to greater happiness if we
connect it to our emotions,” Dr. Ubel said. “Analytic
thinking typically dampens people’s moods. For instance,
spend a little time analyzing why you love someone and you
32
won’t soon swoon. But spend
some time thinking about how
your partner makes you feel,
and you will probably feel
much better.”
Most important of all, Dr.
Ubel recommends sharing your
feelings about good experiences
with your friends. “Sharing
good events increases the
strength and duration of your
positive feelings. Positive events
take on more meaning when
shared with people we love.
That’s why we have birthday
parties and wedding celebrations and graduation events.
“Positive moods can feed on themselves, and we can
harness that phenomenon to our advantage. When we
experience happy events in our lives, we should take time
to savor them and celebrate them with friends. Doing that
assures that they will bring us even greater happiness.
“I have changed the way I practice medicine since
writing this book. I now focus on helping my patients find
a number of ways to improve their lives, not just through
medicine.
“People can bolster their resilience, regardless of
their personalities,” Dr. Ubel said. “If I had to give one
suggestion, I would urge people to take 10 minutes out of
every day to think — meditate, pray, write down thoughts
— about what goals they want to pursue in their lives.
What do they want to accomplish in the next day, week, six
months or six years? Then take time to think about how to
accomplish those goals. If the goals are out of reach, think
of intermediate steps you can take to move in that direction.
Life is too precious for us to let it slip by without spending
time pursuing those things that matter the most to us.”
Goals take our focus from the adversity of the present
and fix it somewhere in a future that is yet unformed. Our
ancestors faced challenges and obstacles, and they gave us
the tools to meet the challenge. All human beings are wired
for this, but stroke survivors have been specially selected by
fate to demonstrate this capacity.
Dr. Peter Ubel is a
professor of medicine
at the University of
Michigan School of
Medicine.
33
diabetes
and stroke
by Jim Batts
you have diabetes mellitus, you are among the many
who have one of the primary risk factors for stroke.
Sometimes diabetes can be prevented. Usually it can be
managed, with you and your doctor working as a team.
Diabetes is a progressive disease in which your body
doesn’t make enough of the insulin hormone and doesn’t
respond properly to insulin. Scientifically speaking,
diabetes is defined as a fasting blood glucose level of
126 milligrams per deciliter, or more, measured on two
occasions. The only way to find out if you have diabetes
is to be tested through a healthcare provider.
34
the types of diabetes
There are two types of diabetes.
Type 2 diabetes, the most common form, appears most often in middle-aged
adults, but recently is being seen more often in both children and young adults.
In type 2, your pancreas doesn’t produce enough insulin or the cells ignore the
insulin. Type 1 diabetes usually appears at younger ages. In type 1, your pancreas
makes little or no insulin. Your body uses insulin to convert sugar, starches and
other foods into energy. Without injections of insulin, people with type 1 diabetes
won’t survive.
Diabetes increases the likelihood that arteries may develop a condition
called atherosclerosis and the formation of a sticky buildup called plaque.
Plaque can rupture, causing a blood clot, or a piece can break off and travel to
another part of the body and block a vessel. If a blockage occurs in your brain,
you can have a stroke.
With healthy arteries, when the stroke cuts off oxygen to part of your brain,
other arteries may take over and still deliver some oxygenated blood. But if you
have diabetes, many of your potential bypass arteries may also have been damaged
by atherosclerosis, making natural bypass less likely. The affected part of your
brain is more likely to be starved for oxygen and more severely damaged.
Researchers haven’t pinpointed how diabetes influences development of
atherosclerosis, or why it occurs prematurely in people with diabetes, but obesity,
high blood pressure and high cholesterol levels are high on the suspect list.
Diabetes also tends to lower “good” cholesterol and to raise “bad” cholesterol
and triglycerides levels, raising the risk of stroke and heart disease.
Diabetes delivers bad news in other ways, too. People with diabetes tend to
have more severe heart disease. They also have a higher risk of congestive heart
failure and other complications.
Diabetes causes nerve damage that makes painless heart attacks more likely and
harder to diagnose. Heart attacks are more likely to be fatal in people with diabetes.
And . . . besides being a risk factor for stroke and heart disease, diabetes can
cause or lead to blindness, kidney disease, nerve disease and can lead to the need
to amputate limbs.
You can help delay the onset of type 2 diabetes by eating a healthy diet and
becoming more physically active on a regular basis. Prevention includes visiting
your doctor and being tested to see if you have diabetes.
Diabetes is one of six major modifiable risk factors for cardiovascular disease
— including stroke. The other five are smoking, high blood cholesterol, high
blood pressure, physical inactivity and obesity or overweight.
The American Diabetes Association (ADA) warns that “diabetes often goes
undiagnosed because many of its symptoms seem so harmless.” Some diabetes
symptoms include:
• Frequent urination
• Excessive thirst
• Extreme hunger
• Unusual weight loss
• Increased fatigue
• Irritability
• Blurry vision
The ADA points to recent studies indicating that the early detection of
diabetes symptoms, and early treatment, can decrease the chance of developing
complications of diabetes. One or more of these symptoms calls for a quick visit
with your doctor. You can also visit the ADA’s Web site — www.diabetes.org/
home.jsp — and take its online diabetes risk test to get an idea of where you stand.
how big is the
diabetes problem?
Diabetes affects more people in
the United States than you might
expect.
• The most recent statistics report
annual deaths with diabetes as
an underlying or contributing
cause came to 224,100.
• About 14.1 million people
in the United States have
physician-diagnosed diabetes,
and an estimated 6 million are
undiagnosed. The prevalence of
those diagnosed has increased
61 percent since 1990.
• Each year, over 13,000 children
in the United States are
diagnosed with type 1 diabetes,
and healthcare providers are
finding more and more children
and teens with type 2 diabetes.
• The risk for stroke among people
with diabetes is two to four
times higher than the rest of the
population, and an estimated
49 to 69 million adults in the
United States may have insulin
resistance, another term for prediabetes.
(continued)
35
getting to the heart of diabetes
The American Heart Association’s The Heart Of Diabetes: Understanding
Insulin Resistance is a free 12-month program that educates people about the
association between cardiovascular disease, diabetes and insulin resistance.
If you have type 2 diabetes, you should help control your heart disease risk
through regular physical activity, nutrition and cholesterol management. To register
for the program, call 1-800-AHA-USA1 or visit americanheart.org/diabetes.
‘pre-diabetes’ — the need for
informed self-defense
the metabolic syndrome —
piling on the risks
According to the American Diabetes Association,
people almost always have “pre-diabetes” before they
develop type 2 diabetes. Their blood glucose (sugar)
levels are higher than normal, but not high enough to be
diagnosed as diabetes.
Don’t let the “pre”
part of the name lull
you into taking the
symptoms lightly. The
truth is, most people
with pre-diabetes
develop diabetes within
10 years. If you have
pre-diabetes, accept the
condition as a serious
wake-up call.
The temptation is to
look at the risk factors
and think, “I’ll take
care of those later.”
But “later” can become
“someday” and “someday” can become “too late.”
Self-defense starts with knowledge. You should be tested
for pre-diabetes if you are age 45 or older and overweight,
or if you are under 45 and have even one of these:
Imagine young boys playing in a park. One falls down. A
second jumps on him. Then a third, and so on until five are
pressing him down. The boy had some risk of injury when
the first playmate jumped on him. By the time all five have
piled on, the boy is at much greater overall risk.
That’s the way it is with the metabolic syndrome,
which is the simultaneous presence of at least three of five
metabolic abnormalities in one person. These abnormalities
include abdominal obesity, high fasting levels of blood
sugar, high levels of triglycerides, low levels of HDL
(“good” cholesterol), and high blood pressure.
Aspects of all of these abnormalities are present in the
standard risk factors for cardiovascular diseases, including
stroke, but the “piling on” effect makes the metabolic
syndrome more serious.
Metabolic syndrome may almost double your risk
of stroke, researchers reported at the American Stroke
Association’s 29th International Stroke Conference. The
findings suggest that treating the risk-factor components of
metabolic syndrome might reduce stroke risk factors before
the onset of type 2 diabetes, said the study’s lead author,
Robert M. Najarian, a third-year medical student at Boston
University School of Medicine.
The study found that compared to people without
metabolic syndrome, men with the condition have a 78
percent greater risk of stroke, and affected women have more
than double the stroke risk of women who don’t have the
syndrome. The overall stroke risk associated with metabolic
syndrome remained below that of people with diabetes.
Patients with diabetes had a significantly higher 10-year
risk of stroke.
The latest estimate is that 47 million U.S. residents have
metabolic syndrome (often referred to as MetS).
“Metabolic syndrome looks like the precursor for a
number of health problems,” Najarian said. “Because the
prevalence of the syndrome is so high, we need to start
thinking about how to prevent the condition, particularly
since it appears to be a factor in the continuum that leads to
outright diabetes and cardiovascular disease.”
• high blood pressure
• low HDL cholesterol and high triglycerides
• a family history of diabetes
• a history of gestational diabetes
(diabetes during pregnancy)
• have given birth to a baby weighing
more than 9 pounds
• are African American or Hispanic/Latino
Pre-diabetes or diabetes won’t just go away, so you need
to assess your situation immediately if you suspect diabetes,
and eliminate or reduce the cardiovascular risk factors you
can do something about. And see your doctor.
36
the receipt that saved a life
Robert Hawkes finished his meal at a
favorite seafood restaurant in Houston,
paid his bill, slipped the receipt into his
billfold and headed for home. It was a
little after 8 p.m.
As he was driving, his right arm
suddenly weakened and wouldn’t
respond. Then “it became normal again,”
Robert said, “but when I stopped at a red
light about a mile from home, I felt really
sick at my stomach and just felt funny. I
never felt anything like that before.”
Robert somehow drove into his
garage, but it took him three to four
minutes to figure out how to turn off
the car.
He walked to pick up his mail and
fell in his yard. “I think I’m having a
stroke,” he remembers thinking. “I have
to get to the doctor in a hurry.” He even
considered rolling himself into the garage,
“but I managed to get up and walk.”
He called a daughter, Sharlene,
though he had trouble focusing to touch
the right numbers. She immediately
asked, “Daddy, are you all right?”
“I said ‘no,’ but it came out as
gibberish.” Sharlene called 9-1-1 from
her house and sped to him. Emergency
personnel rushed him to a hospital.
Robert, who was 74, was experiencing a
left-hemisphere ischemic stroke. The left
carotid artery in his neck was about 70
percent blocked.
At the hospital, Sharlene told doctors
that her dad should receive the clotbuster
shortly after 9 p.m., and it now was about
9:30 p.m. He was within the three-hour
window.
“They got on it really fast and gave me
the tPA,” Robert said.
Over the next seven days he began
to speak in one-syllable words, “a
little better every day. But my vision
wasn’t right. I could see the left side of
someone’s face, but not the right. They
said I had ‘right-vision cut.’ It would come
and go.” It eventually went away.
About a month after the stroke,
doctors operated and cleared the
obstruction in Robert’s left carotid artery.
But his difficulties weren’t over.
Just after Christmas 2005, he had a
“silent” painless heart attack, an event
experienced by about 175,000 people a
year. “My doc said many diabetics don’t
feel heart attacks,” Robert said. He was
rushed to the hospital short of breath
and with his lungs filling with fluid. The
cardiologist said that 37 percent of his heart
had been “hibernating,” not functioning.
He was treated successfully and went
through 90 days of cardiac rehab. He is
doing well now under doctors’ care.
Robert has recovered from the stroke
and heart attack well enough to drive his car
again — “to church and everywhere. I can
do everything I want to do.
“I can’t speak really well [you couldn’t
prove it from a recent telephone interview
— ed] and my reading is slow.”
He walks about two miles a day on a
Top: Robert Hawkes, survivor
Above: Robert and daughter Sharlene
These are four of the five abnormalities
that add up to the metabolic syndrome.
The other is abdominal obesity. If you
have just three of the five, you are
said to have the metabolic syndrome,
which puts you at compounded risk for
cardiovascular disease and stroke.
The question remains:
Did Robert’s diabetes
play a role in his stroke?
He doesn’t know. “The
doctors never mentioned
it,” he said, “and I don’t recall ever being
told that diabetes was a stroke risk.”
He does know to do all he can
to lower his risk for stroke and heart
disease. This includes seeing his doctors
when scheduled, taking all medicines as
directed, eating right and exercising. His
LDL “bad” cholesterol is now at 80, and
he’s trying to lower it to 70. Robert is a
retired auditor with the U.S. Department of
Defense. “That was my job then,” he said.
“Taking care of myself is my job now.”
did robert hawkes’ diabetes play a role in his stroke?
drug tPA, which must be given within
three hours of the first stroke symptoms.
The doctor said the family had to prove
Robert was still within the three hours.
“I called Dad at the restaurant
tonight,” Sharlene told the doctor. “It was
around 7:20. He was okay.” The doctor
wanted better evidence, so Sharlene said,
“Let me see Dad’s billfold.” She found
the restaurant receipt, which included the
exact time of the transaction: 7:30 p.m.
Robert had arrived at the hospital
treadmill, lifts weights, does calisthenics
and stays busy. He has pleasure trips
scheduled this year to Virginia’s Outer
Banks and to British Columbia.
Robert has a history of cardiovascular
disease. He had heart bypass surgery in
1991, and was diagnosed with diabetes
in 1992. He is under treatment for high
blood pressure, high fasting levels of
blood sugar, high levels of triglycerides
and low levels of HDL, the “good”
cholesterol.
37
&
Thoughts
ts
Feelings
My husband Lyle Peters is a retired Lutheran
pastor. He had a severe stroke in the parking lot of a golf
course in October 2001. He was 68 years old.
He went through the usual physical, occupational and
speech therapy. However, his stroke was so severe that
it left him with aphasia and without the use of his right
arm. I was able to take care of him at home until March
2005, when he entered a healthcare facility here in Des
Moines. He walks with the aid of a quad cane and the
help of two people.
This poem and essay reflect my thoughts and feelings
on how the stroke has affected us. Perhaps other survivors
and caregivers have similar feelings about having their
lives changed so dramatically from a stroke. I know you
publish “success” stories, but not all stroke families have
success stories. Some of us live a painful life following
the stroke.
Stroke
after
by Marvel Peters, Caregiver
Des Moines, Iowa
38
THE THIEF
T
he thief came midday that October day. Why did
you come to take away the things I love? The eyes
now can only tell of his love, but once in a while
the words come out “I love you.”
The smile is there and the feelings too, but
you took away the strength of the arms that held
so tenderly. You took away the strength of the legs that jogged,
swam and danced so well. But the smile is there, and the eyes
tell the pain of feeling the loss of holding me, our children and
grandchildren. Oh, how he would love to pick up and play with
that great-grandchild when she comes to see us. But the smile
is there, and the eyes tell of his love.
How can he endure the pain of being trapped inside
himself, wanting to express himself, his feelings, his likes and
dislikes? Why must he accept what I do, where we go, what he
has to eat, my choice not his!
Who is the thief who did this to him? Who and why, that’s
all I ask. So unfair to someone who gave himself to serve
God and his fellow man, so trusting and compassionate,
understanding others’ feelings but now can’t express his own.
The eyes tell the story. Why, oh why, thief, did you do this to
him? I don’t understand! How long must he endure this?
The days are long, the nights sometimes long, sometimes
short. Another day of sitting and looking and thinking.
Thinking about what? He can’t tell anyone. What does he think
about all day? Does he sing to himself? Does he pray? Does he
talk to himself? What does he wonder about all to himself?
Thank goodness for TV. He watches and seems to
comprehend the news — good or bad. Sports, he’s interested
in all sports. Then he sees golf on TV. What does he think
about golf — the golf course — that’s where the thief came.
“People have…” — to everything he says those words. Why
those words? People, yes, he thinks and cares about people.
His work was helping people. He has a genuine concern for all
people. He always helped people — now people have to help
him, in everything he does. How humiliating it must be, not
being able to take care of your personal needs. Why, thief, did
you take so much of him away?
I don’t understand, but I must accept his pain and loss
— not only my pain and loss, but he’s trapped inside a body
that doesn’t want to move easily. It’s hard to watch, and I
need patience. How long can we continue like this? How long
must we continue?
(continued)
Who is the
thief who did
this to him?
Who and why,
that’s all I ask.
Photos, clockwise from left: Marvel and Lyle Peters with
their grandchildren, Skyla and Reese; the Peters family
celebrate Lyle & Marvel’s 50th wedding anniversary;
Lyle with his friend and nursing assistant Lisa.
39
MY BEST FRIEND
My best friend and I had so much to talk about.
Now he can only get a few words out, no matter
how hard he tries.
Getting older, health not what it once was.
Taking care of oneself wasn’t enough to stop
the thief from taking so much of my best friend.
The eyes speak to me of his wants and desires.
What are they really saying? Am I listening to
what he really is saying with the eyes?
Decisions had to be made. Not an easy choice
for one to make on behalf of another. My best
friend and I now live apart, it’s not easy
for either of us.
Alone, can’t speak, can’t walk alone, can’t read,
can’t write ... trapped within a body that once
was so active, so alert, so vibrant.
My best friend for so much of my youth. First
date, first kiss, first love. We married, raised a
family together, my best friend and me.
Now life has changed for both of us. We each
are alone, but not really alone. We still have
each other but in a different way.
What made the change? Not by choice, fate had
a part in this change. No one would choose to
make such a dramatic change.
Days spent in his room. Trying to make
conversation, to encourage, to keep his mind
alert and aware. Choices to make — lifelong
choices, changes for better or worse.
My best friend and I hold each other at the end
of the day. Once again, a good-bye kiss and
hug. Saying good night, see you tomorrow. My
best friend smiles and I walk away.
—July 29, 2005, midnight
O\f`>\m`jatjpmn`ga
>c\mh
N``fc`gkamjhjoc`mn
<Gdoog`
Bj`n\GjibR\t
H\dio\dia\^ònjatjpmjrigda`
@skm`nn_d^pgo`hjodjin
Mè`ôh\idkpg\odji
M`^`dq`\nr`gg\nj`m\`ôdji
<kkg\p_tjpm^jpm\b`\n\^\m`bdq`m
CAREGIVER AD
Kmjo`ôtjpmdi_dqd_p\gdot
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=`^jhdib\^\m`bdq`majmnjh`ji`m`lpdm`n\
gjib(o`mh^jhhdohìojaodh`\i_ì`mbt)
=pok`mc\kn`qìhjm`dhkjmo\iogt'o\fdib
^\m`jatjpmn`gardgg]`^mdod^\gojnp^^`nn)
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amjhoc`>\m`bdq`mn=dggjaMdbcon)
40
@q`mtkpm^c\n`rdggnpkkjmo`_p^\odji\i_
^jhhpidotkmjbm\hn)>jind_`mdo\idiq`nohìo
ditjpmjriapopm`'\nr`gg\noc`c`\goc\i_
r`gg(]`dibjatjpma\hdgt\i_amdì_n)
QdndoNomjf`<nnj^d\odji)jmb*^\m`bdq`m
ojjm_`mtjpm>\m`bdq`m=m\^`gòoj_\t
Up, Up and Away
The perfect outfit for airport security is a hospital gown. This
occurred to me while I was trying to collect my coat, backpack, keys, belt and
shoes from all those little plastic boxes on the X-ray machine conveyor belt. I
was grateful I still had my shirt and pants on.
Because I couldn’t retrieve my stuff fast
enough with one hand, my little plastic boxes
were being pushed by the little plastic boxes that
contained the coat, keys, belt and shoes of the guy behind me
followed by his family’s little plastic boxes. I managed to create a traffic
jam of little plastic boxes like the bumper car ride at an amusement park.
In many ways an airport is like an amusement park, only the food is worse.
It’s a daunting place anyway, but after a stroke it’s an obstacle course with
booby traps, like escalators, elevators, tiny electric cars and even conveyor
belts for moving people. Our plane was at gate B47 on the upper concourse.
We tried to take the elevator, but there were hundreds of black SUV-size rolling
suitcases lined up in front of the door like dominoes with a person standing
next to each one.
The escalator was free and clear. Oh great, moving stairs. I must have fallen
into a trance watching each step coming out of the floor trying to get that first
one timed perfectly. I didn’t notice the line forming behind me.
Finally a kind, elderly gentleman broke my spell when he yelled, “Hey buddy,
on or off. I got a frickin’ plane to catch over here!”
This traffic jam thing was becoming a trend with me. My wife, Marylin,
already on the upper concourse, was encouraging me on like a parent teaching
her kid to ride a two-wheeler. I closed my eyes, took a step, and whew, I was
on, leaving all those people behind me only to encounter more on the upper
concourse.
There was a large crowd trying to get on the down escalator, and they
overflowed in front of the up escalator. OK, now I had to get off. When I get
excited or anxious my affected left elbow raises up involuntarily. I look like
a motorcycle with a sidecar, but like a linebacker it came in handy pushing
through that sea of people.
Marilyn was already on her way to the gate where Delta flight 1050A had
two seats with our names on them. All we had was
a carry-on, but it pays to board early to ensure an
In many ways an airport is like
overhead compartment. We had just discovered that
an amusement park, only the
people with disabilities board first.
food is worse. It’s a daunting
As I approached the gate I could see Marilyn
talking
to the ticket collector and pointing to me. I
place anyway, but after a
don’t use a cane so I tried to look as bad as I could,
stroke it’s an obstacle course. bumping into walls and tripping over suitcases. If I
wore sunglasses and held a cup, people would have
given me their spare change. While this was going on I almost got run over by
one of those tiny luggage-carrying electric cars moving at the speed of light.
The ticket collector let us board early, not because of my disability, but
because he thought everyone in the airport would be safer with me sitting in
the plane!
Life
at the
curb
Comedian and stroke
survivor John Kawie’s
unique perspective
on stroke survival
Editor’s Note: Read John’s personal stroke story, “Life is at the Curb,” from the September/
October 2003 issue of Stroke Connection at strokeassociation.org/strokeconnection,
or book his one-man show about stroke recovery, “Brain Freeze,” by contacting him at
[email protected].
41
E V E RY D AY
C o n n e c t i n g Yo u t o H e l p f u l I d e a s
Books About Stroke
The Emotional Survival Guide for
Caregivers: Looking after Yourself
and Your Family while Helping an
Aging Parent
By Barry J. Jacobs, Psy.D.
The Guilford Press
ISBN-10 1-57230-729-3
Life after Stroke: The Guide to
Recovering Your Health and
Preventing Another Stroke
By Joel Stein, M.D.; Julie Silver, M.D.;
Elizabeth Pegg Frates, M.D.
The Johns Hopkins
University Press
ISBN 0-8018-8364-4
Caring for an aging parent
or ill spouse is both deeply
rewarding and costly to the
caregiver physically and
psychologically. Whether
you’re tired of clashes
with siblings, frustrated
that your parent no longer
seems to appreciate your
help, or confused by
mixed feelings, you’re not
alone. Dr. Jacobs has long
experience addressing these issues. This book can help
you make sense of the turmoil and teach you how to
cope with competing loyalties, role reversals and trials
of illness.
In this compassionate
guide, three physicians
who treat people with
stroke describe how
to navigate the path to
recovery. They explain
how stroke occurs and
what happens when
different parts of the
brain are injured. They
discuss diagnostic tools
such as CT scans and MRIs as well as medications
used to prevent and treat stroke, and they explain how
survivors can heal optimally. They also include the
Stroke Savvy Exercise and Diet Plans.
Stranger in the Mirror: A True Story
of Stroke Survival and Transformation
Growing Old Is Not for Sissies:
A Senior’s Story of Love and Devotion
Told from a Dual Perspective
By Michael Edward Little
By Gerald and Pauline McClosky
AuthorHouse
ISBN 1-4259-0726-1
ISBN 1-4196-1158-5
This book is the story of
Michael Little’s recovery
from a hemorrhagic stroke
that left him unable to walk,
talk, see or think clearly.
But Mike refused to be
defined by his disability,
and his story demonstrates
that our limitations are selfimposed. Facing tragedy
with humor, grit and grace,
he found redemption. He
passionately advocates that people take ownership of
their recovery as survivors, not as victims.
While the title suggests
this is a book about aging,
the story grew out of
the authors’ experience
with a stroke. It is a story
about life after stroke
and the caregiver’s role.
It is also a story of how
an unexpected trauma is
met with love, courage,
determination and hope.
Their story is a great
example of how we are not
defined by what happens to us but by how we
respond to it.
These book summaries are provided as a resource to our readers. These books have not been reviewed or endorsed by the American Stroke Association.
42
Web Site Helps
Caregivers Help
Themselves
new American Heart
Association/American
Stroke Association Web site
— strokeassociation.org/
caregiver — is addressing
the emotional needs of the
approximately 50 million people in the United
States caring for a family member or friend who
has a chronic medical condition.
Many of these people are helping survivors
of heart disease or stroke, the nation’s No.
1 and No. 3 killers and the cause of many
disabilities survivors can’t manage alone. The
need for more caregivers is expected to grow rapidly as
the population ages.
“This new Web site provides practical resources for
caregivers who don’t have any training and suddenly find
themselves in this situation,” said Barry Jacobs, Psy.D.,
A
“This new Web site provides
practical resources for
caregivers who don’t have
any training and suddenly find
themselves in this situation.”
a clinical psychologist, family therapist and author of the
book The Emotional Survival Guide for Caregivers. “The
demands put on family members in a caregiving role are
increasing, and we need to offer the resources to help
them cope.”
A recent online survey of caregivers who use the
primary American Heart Association and American Stroke
Association Web sites and other resources confirmed that
family caregivers who give so much to their loved ones
need more and better help to care for themselves.
Most caregivers surveyed reported having personal
risk factors for heart disease, stroke and many other
diseases. Risks mentioned frequently included high
blood pressure, high cholesterol, diabetes and obesity.
Caregivers also reported that feelings of stress,
depression and anxiety were common, and said they
need help to manage their feelings.
The AHA and ASA have responded with a suite
of materials to support caregivers, including the new
Web site. With sections titled “Rejuvenate,” “Refresh,”
“Reach Out” and “Replenish,” the site gives caregivers
practical, proven ways to take charge of their own
health and emotional well-being. Modules include tips
for communicating with family and friends about their
situation, a guide to healthy eating and food preparation,
as well as Heart of Caregiving, a downloadable journal
to help them prioritize how best to take care of their
personal needs.
“I frequently see patients who are not only burdened by
the emotional strain of caregiving, but are also letting their
physical health decline as a result of the entire focus being
on the family member,” Jacobs said. “This Web site is a
great reminder that the emotional and physical health of
the caregiver is just as important as the health of the
person for whom they are caring.”
43
E V E RY D AY
C o n n e c t i n g Yo u t o H e l p f u l I d e a s
Resources
National Family
Caregivers Alliance
he National Family Caregivers Association (NFCA)
supports, empowers, educates and speaks up for
the more than 50 million Americans who care for a
chronically ill, aged or disabled loved one. NFCA reaches
across the boundaries of different diagnoses, different
relationships and different life stages to address the
common needs and concerns of all family caregivers.
NFCA follows four core principles:
T
• Choose to take charge of your life.
• Love, honor and value yourself.
• Seek, accept and at times demand help.
• Stand up and be counted.
Their TAKE CARE! newsletter is a great resource, and
their story project allows caregivers to tell their stories.
It is full of heartbreaking and heartwarming stories. In
addition there’s a Q&A with Dr. Barry Jacobs in every
issue. NFCA membership is free to family caregivers.
APS Foundation
of America, Inc.
ntiphospholipid Antibody Syndrome (APS) is
an autoimmune disorder in which the body
recognizes certain normal components of
blood and/or cell membranes as foreign substances
and produces antibodies against them. Patients with
these antibodies may experience blood clots, and have
associated events including heart attacks, strokes,
miscarriages and arterial and venous thrombosis.
APS may occur in people with systemic lupus,
other autoimmune diseases, or in otherwise healthy
individuals. APS is also a blood-clotting disorder,
thus affecting many different areas of the body.
Although there is no cure for APS, it is treatable with
anticoagulants.
A
APS Foundation of America, Inc.
PO Box 801
La Crosse, WI 54602-0801
608-782-2626
www.apsfa.org
44
National Family Caregivers Association
10400 Connecticut Avenue, Suite 500
Kensington, MD 20895-3944
1-800-896-3650
www.thefamilycaregiver.org
PLAVIX®
Rx only
clopidogrel bisulfate tablets
INDICATIONS AND USAGE
PLAVIX (clopidogrel bisulfate) is indicated for the reduction of atherothrombotic events as
follows:
• Recent MI, Recent Stroke or Established Peripheral Arterial Disease
For patients with a history of recent myocardial infarction (MI), recent stroke, or established
peripheral arterial disease, PLAVIX has been shown to reduce the rate of a combined endpoint of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death.
• Acute Coronary Syndrome
For patients with acute coronary syndrome (unstable angina/non-Q-wave MI) including
patients who are to be managed medically and those who are to be managed with percutaneous coronary intervention (with or without stent) or CABG, PLAVIX has been shown to
decrease the rate of a combined endpoint of cardiovascular death, MI, or stroke as well as
the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia.
CONTRAINDICATIONS
The use of PLAVIX is contraindicated in the following conditions:
• Hypersensitivity to the drug substance or any component of the product.
• Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.
WARNINGS
Thrombotic thrombocytopenic purpura (TTP):
TTP has been reported rarely following use of PLAVIX, sometimes after a short exposure
(<2 weeks). TTP is a serious condition that can be fatal and requires urgent treatment
including plasmapheresis (plasma exchange). It is characterized by thrombocytopenia,
microangiopathic hemolytic anemia (schistocytes [fragmented RBCs] seen on peripheral
smear), neurological findings, renal dysfunction, and fever. (See ADVERSE REACTIONS.)
PRECAUTIONS
General
PLAVIX prolongs the bleeding time and therefore should be used with caution in patients who
may be at risk of increased bleeding from trauma, surgery, or other pathological conditions
(particularly gastrointestinal and intraocular). If a patient is to undergo elective surgery and
an antiplatelet effect is not desired, PLAVIX should be discontinued 5 days prior to surgery.
Due to the risk of bleeding and undesirable hematological effects, blood cell count determination and/or other appropriate testing should be promptly considered, whenever such suspected clinical symptoms arise during the course of treatment (see ADVERSE REACTIONS).
In patients with recent TIA or stroke who are at high risk for recurrent ischemic events, the
combination of aspirin and PLAVIX has not been shown to be more effective than
PLAVIX alone, but the combination has been shown to increase major bleeding.
GI Bleeding: In CAPRIE, PLAVIX was associated with a rate of gastrointestinal bleeding of
2.0%, vs. 2.7% on aspirin. In CURE, the incidence of major gastrointestinal bleeding was 1.3%
vs 0.7% (PLAVIX + aspirin vs. placebo + aspirin, respectively). PLAVIX should be used with
caution in patients who have lesions with a propensity to bleed (such as ulcers). Drugs that
might induce such lesions should be used with caution in patients taking PLAVIX.
Use in Hepatically Impaired Patients: Experience is limited in patients with severe hepatic
disease, who may have bleeding diatheses. PLAVIX should be used with caution in this
population.
Use in Renally-impaired Patients: Experience is limited in patients with severe renal
impairment. PLAVIX should be used with caution in this population.
Information for Patients
Patients should be told it may take them longer than usual to stop bleeding, that they may
bruise and/or bleed more easily when they take PLAVIX or PLAVIX combined with aspirin,
and that they should report any unusual bleeding to their physician. Patients should inform
physicians and dentists that they are taking PLAVIX and/or any other product known to
affect bleeding before any surgery is scheduled and before any new drug is taken.
Drug Interactions
Study of specific drug interactions yielded the following results:
Aspirin: Aspirin did not modify the clopidogrel-mediated inhibition of ADP-induced
platelet aggregation. Concomitant administration of 500 mg of aspirin twice a day for 1 day
did not significantly increase the prolongation of bleeding time induced by PLAVIX. PLAVIX
potentiated the effect of aspirin on collagen-induced platelet aggregation. PLAVIX and
aspirin have been administered together for up to one year.
Heparin: In a study in healthy volunteers, PLAVIX did not necessitate modification of the
heparin dose or alter the effect of heparin on coagulation. Coadministration of heparin had
no effect on inhibition of platelet aggregation induced by PLAVIX.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): In healthy volunteers receiving naproxen,
concomitant administration of PLAVIX was associated with increased occult gastrointestinal
blood loss. NSAIDs and PLAVIX should be coadministered with caution.
Warfarin: Because of the increased risk of bleeding, the concomitant administration of
warfarin with PLAVIX should be undertaken with caution. (See PRECAUTIONS– General.)
Other Concomitant Therapy: No clinically significant pharmacodynamic interactions were
observed when PLAVIX was coadministered with atenolol, nifedipine, or both atenolol and
nifedipine. The pharmacodynamic activity of PLAVIX was also not significantly influenced by
the coadministration of phenobarbital, cimetidine or estrogen.
The pharmacokinetics of digoxin or theophylline were not modified by the coadministration
of PLAVIX (clopidogrel bisulfate).
At high concentrations in vitro, clopidogrel inhibits P450 (2C9). Accordingly, PLAVIX may
interfere with the metabolism of phenytoin, tamoxifen, tolbutamide, warfarin,
torsemide, fluvastatin, and many non-steroidal anti-inflammatory agents, but there
are no data with which to predict the magnitude of these interactions. Caution should be
used when any of these drugs is coadministered with PLAVIX.
In addition to the above specific interaction studies, patients entered into clinical trials
with PLAVIX received a variety of concomitant medications including diuretics, beta-blocking
agents, angiotensin converting enzyme inhibitors, calcium antagonists, cholesterol
lowering agents, coronary vasodilators, antidiabetic agents (including insulin),
antiepileptic agents, hormone replacement therapy, heparins (unfractionated and
LMWH) and GPIIb/IIIa antagonists without evidence of clinically significant adverse interactions. The use of oral anticoagulants, non-study anti-platelet drug and chronic NSAIDs was
not allowed in CURE and there are no data on their concomitant use with clopidogrel.
Drug/Laboratory Test Interactions
None known.
Carcinogenesis, Mutagenesis, Impairment of Fertility
There was no evidence of tumorigenicity when clopidogrel was administered for 78 weeks
to mice and 104 weeks to rats at dosages up to 77 mg/kg per day, which afforded plasma
exposures >25 times that in humans at the recommended daily dose of 75 mg.
Clopidogrel was not genotoxic in four in vitro tests (Ames test, DNA-repair test in rat hepatocytes, gene mutation assay in Chinese hamster fibroblasts, and metaphase chromosome analysis of human lymphocytes) and in one in vivo test (micronucleus test by oral route in mice).
Clopidogrel was found to have no effect on fertility of male and female rats at oral doses
up to 400 mg/kg per day (52 times the recommended human dose on a mg/m2 basis).
Pregnancy
Pregnancy Category B. Reproduction studies performed in rats and rabbits at doses up to
500 and 300 mg/kg/day (respectively, 65 and 78 times the recommended daily human dose
on a mg/m2 basis), revealed no evidence of impaired fertility or fetotoxicity due to clopidogrel. There are, however, no adequate and well-controlled studies in pregnant women.
Because animal reproduction studies are not always predictive of a human response, PLAVIX
should be used during pregnancy only if clearly needed.
Nursing Mothers
Studies in rats have shown that clopidogrel and/or its metabolites are excreted in the milk.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted
in human milk and because of the potential for serious adverse reactions in nursing infants,
a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the nursing woman.
Pediatric Use
Safety and effectiveness in the pediatric population have not been established.
Geriatric Use
Of the total number of subjects in controlled clinical studies, approximately 50% of patients
treated with PLAVIX were 65 years of age and over. Approximately 16% of patients treated
with PLAVIX were 75 years of age and over.
The observed difference in risk of thrombotic events with clopidogrel plus aspirin versus
placebo plus aspirin by age category is provided in Figure 3 (see CLINICAL STUDIES). The
observed difference in risk of bleeding events with clopidogrel plus aspirin versus placebo
plus aspirin by age category is provided in Table 3 (see ADVERSE REACTIONS).
ADVERSE REACTIONS
PLAVIX has been evaluated for safety in more than 17,500 patients, including over 9,000
patients treated for 1 year or more. The overall tolerability of PLAVIX in CAPRIE was similar
to that of aspirin regardless of age, gender and race, with an approximately equal incidence
(13%) of patients withdrawing from treatment because of adverse reactions. The clinically
important adverse events observed in CAPRIE and CURE are discussed below.
Hemorrhagic: In CAPRIE patients receiving PLAVIX, gastrointestinal hemorrhage occurred
at a rate of 2.0%, and required hospitalization in 0.7%. In patients receiving aspirin, the corresponding rates were 2.7% and 1.1%, respectively. The incidence of intracranial hemorrhage was 0.4% for PLAVIX compared to 0.5% for aspirin.
In CURE, PLAVIX use with aspirin was associated with an increase in bleeding compared to
placebo with aspirin (see Table 3). There was an excess in major bleeding in patients receiving PLAVIX plus aspirin compared with placebo plus aspirin, primarily gastrointestinal and
at puncture sites. The incidence of intracranial hemorrhage (0.1%), and fatal bleeding
(0.2%), were the same in both groups.
The overall incidence of bleeding is described in Table 3 for patients receiving both PLAVIX
and aspirin in CURE,
Table 3: CURE Incidence of bleeding complications (% patients)
Event
PLAVIX
Placebo
P-value
(+ aspirin)*
(+ aspirin)*
(n=6259)
(n=6303)
Major bleeding †
3.7 ‡
2.7 §
0.001
Life-threatening bleeding
2.2
1.8
0.13
Fatal
0.2
0.2
5 g/dL hemoglobin drop
0.9
0.9
Requiring surgical intervention
0.7
0.7
Hemorrhagic strokes
0.1
0.1
Requiring inotropes
0.5
0.5
Requiring transfusion (≥4 units)
1.2
1.0
Other major bleeding
1.6
1.0
0.005
Significantly disabling
0.4
0.3
Intraocular bleeding with
significant loss of vision
0.05
0.03
Requiring 2-3 units of blood
1.3
0.9
Minor bleeding ¶
5.1
2.4
<0.001
* Other standard therapies were used as appropriate.
† Life threatening and other major bleeding.
‡ Major bleeding event rate for PLAVIX + aspirin was dose-dependent on aspirin:
<100 mg=2.6%; 100-200 mg= 3.5%; >200 mg=4.9%
Major bleeding event rates for PLAVIX + aspirin by age were: <65 years = 2.5%, ≥65 to
<75 years = 4.1%, ≥75 years 5.9%
§ Major bleeding event rate for placebo + aspirin was dose-dependent on aspirin:
<100 mg=2.0%; 100-200 mg= 2.3%; >200 mg=4.0%
Major bleeding event rates for placebo + aspirin by age were: <65 years = 2.1%, ≥65 to
<75 years = 3.1%, ≥75 years 3.6%
¶ Led to interruption of study medication.
Ninety-two percent (92%) of the patients in the CURE study received heparin/LMWH, and the
rate of bleeding in these patients was similar to the overall results.
There was no excess in major bleeds within seven days after coronary bypass graft surgery
in patients who stopped therapy more than five days prior to surgery (event rate 4.4%
PLAVIX + aspirin; 5.3% placebo + aspirin). In patients who remained on therapy within five
days of bypass graft surgery, the event rate was 9.6% for PLAVIX + aspirin, and 6.3% for
placebo + aspirin.
Neutropenia/agranulocytosis: Ticlopidine, a drug chemically similar to PLAVIX, is associated
with a 0.8% rate of severe neutropenia (less than 450 neutrophils/μL). In CAPRIE severe
neutropenia was observed in six patients, four on PLAVIX and two on aspirin. Two of the 9599
patients who received PLAVIX and none of the 9586 patients who received aspirin had neutrophil counts of zero. One of the four PLAVIX patients in CAPRIE was receiving cytotoxic
chemotherapy, and another recovered and returned to the trial after only temporarily interrupting treatment with PLAVIX (clopidogrel bisulfate). In CURE, the numbers of patients with thrombocytopenia (19 PLAVIX + aspirin vs. 24 placebo + aspirin) or neutropenia (3 vs. 3) were similar.
Although the risk of myelotoxicity with PLAVIX (clopidogrel bisulfate) thus appears to be
quite low, this possibility should be considered when a patient receiving PLAVIX demonstrates fever or other sign of infection.
Gastrointestinal: Overall, the incidence of gastrointestinal events (e.g. abdominal pain, dyspepsia, gastritis and constipation) in patients receiving PLAVIX (clopidogrel bisulfate) was
27.1%, compared to 29.8% in those receiving aspirin in the CAPRIE trial. In the CURE trial the
incidence of these gastrointestinal events for patients receiving PLAVIX + aspirin was 11.7%
compared to 12.5% for those receiving placebo + aspirin.
In the CAPRIE trial, the incidence of peptic, gastric or duodenal ulcers was 0.7% for PLAVIX
(clopidogrel bisulfate) and 1.2% for aspirin. In the CURE trial the incidence of peptic, gastric
or duodenal ulcers was 0.4% for PLAVIX + aspirin and 0.3% for placebo + aspirin.
Cases of diarrhea were reported in the CAPRIE trial in 4.5% of patients in the PLAVIX group
compared to 3.4% in the aspirin group. However, these were rarely severe (PLAVIX=0.2% and
aspirin=0.1%). In the CURE trial, the incidence of diarrhea for patients receiving PLAVIX +
aspirin was 2.1% compared to 2.2% for those receiving placebo + aspirin.
In the CAPRIE trial, the incidence of patients withdrawing from treatment because of gastrointestinal adverse reactions was 3.2% for PLAVIX and 4.0% for aspirin. In the CURE trial,
the incidence of patients withdrawing from treatment because of gastrointestinal adverse
reactions was 0.9% for PLAVIX + aspirin compared with 0.8% for placebo + aspirin.
Rash and Other Skin Disorders: In the CAPRIE trial, the incidence of skin and appendage
disorders in patients receiving PLAVIX was 15.8% (0.7% serious); the corresponding rate in
aspirin patients was 13.1% (0.5% serious). In the CURE trial the incidence of rash or other
skin disorders in patients receiving PLAVIX + aspirin was 4.0% compared to 3.5% for those
receiving placebo + aspirin.
In the CAPRIE trial, the overall incidence of patients withdrawing from treatment because of
skin and appendage disorders adverse reactions was 1.5% for PLAVIX and 0.8% for aspirin. In
the CURE trial, the incidence of patients withdrawing because of skin and appendage disorders
adverse reactions was 0.7% for PLAVIX + aspirin compared with 0.3% for placebo + aspirin.
Adverse events occurring in ≥2.5% of patients on PLAVIX in the CAPRIE controlled clinical
trial are shown below regardless of relationship to PLAVIX. The median duration of therapy
was 20 months, with a maximum of 3 years.
Table 4: Adverse Events Occurring in ≥2.5% of PLAVIX Patients in CAPRIE
Body System
PLAVIX
Aspirin
Event
[n=9599]
[n=9586]
Body as a Whole – general disorders
Chest Pain
8.3 (0.2)
8.3 (0.3)
Accidental/Inflicted Injury
7.9 (0.1)
7.3 (0.1)
Influenza-like symptoms
7.5 (<0.1)
7.0 (<0.1)
Pain
6.4 (0.1)
6.3 (0.1)
Fatigue
3.3 (0.1)
3.4 (0.1)
Cardiovascular disorders, general
Edema
4.1 (<0.1)
4.5 (<0.1)
Hypertension
4.3 (<0.1)
5.1 (<0.1)
Headache
7.6 (0.3)
7.2 (0.2)
Dizziness
6.2 (0.2)
6.7 (0.3)
Abdominal pain
5.6 (0.7)
7.1 (1.0)
Dyspepsia
5.2 (0.6)
6.1 (0.7)
Diarrhea
4.5 (0.4)
3.4 (0.3)
Nausea
3.4 (0.5)
3.8 (0.4)
Metabolic & nutritional disorders
Hypercholesterolemia
4.0 (0)
4.4 (<0.1)
Musculo-skeletal system disorders
Arthralgia
6.3 (0.1)
6.2 (0.1)
Back Pain
5.8 (0.1)
5.3 (<0.1)
Platelet, bleeding, & clotting disorders
Purpura/Bruise
5.3 (0.3)
3.7 (0.1)
Epistaxis
2.9 (0.2)
2.5 (0.1)
Psychiatric disorders
Depression
3.6 (0.1)
3.9 (0.2)
Respiratory system disorders
Upper resp tract infection
8.7 (<0.1)
8.3 (<0.1)
Dyspnea
4.5 (0.1)
4.7 (0.1)
Rhinitis
4.2 (0.1)
4.2 (<0.1)
Bronchitis
3.7 (0.1)
3.7 (0)
Coughing
3.1 (<0.1)
2.7(<0.1)
Skin & appendage disorders
Rash
4.2 (0.5)
3.5 (0.2)
Pruritus
3.3 (0.3)
1.6 (0.1)
Urinary system disorders
Urinary tract infection
3.1 (0)
3.5 (0.1)
Incidence of discontinuation, regardless of relationship to therapy, is shown in parentheses.
Adverse events occurring in ≥2.0% of patients on PLAVIX in the CURE controlled clinical trial
are shown below regardless of relationship to PLAVIX.
Table 5: Adverse Events Occurring in ≥2.0% of PLAVIX Patients in CURE
Body System
PLAVIX
Placebo
(+ aspirin)*
(+ aspirin)*
Event
[n=6259]
[n=6303]
Body as a Whole– general disorders
Chest Pain
2.7 (<0.1)
2.8 (0.0)
Headache
3.1 (0.1)
3.2 (0.1)
Dizziness
2.4 (0.1)
2.0 (<0.1)
Abdominal pain
2.3 (0.3)
2.8 (0.3)
Dyspepsia
2.0 (0.1)
1.9 (<0.1)
Diarrhea
2.1 (0.1)
2.2 (0.1)
*Other standard therapies were used as appropriate.
Other adverse experiences of potential importance occurring in 1% to 2.5% of patients
receiving PLAVIX (clopidogrel bisulfate) in the CAPRIE or CURE controlled clinical trials are
listed below regardless of relationship to PLAVIX. In general, the incidence of these events
was similar to that in patients receiving aspirin (in CAPRIE) or placebo + aspirin (in CURE).
Autonomic Nervous System Disorders: Syncope, Palpitation. Body as a Whole-general disorders: Asthenia, Fever, Hernia. Cardiovascular disorders: Cardiac failure. Central and
peripheral nervous system disorders: Cramps legs, Hypoaesthesia, Neuralgia, Paraesthesia,
Vertigo. Gastrointestinal system disorders: Constipation, Vomiting. Heart rate and rhythm
disorders: Fibrillation atrial. Liver and biliary system disorders: Hepatic enzymes increased.
Metabolic and nutritional disorders: Gout, hyperuricemia, non-protein nitrogen (NPN)
increased. Musculo-skeletal system disorders: Arthritis, Arthrosis. Platelet, bleeding & clotting disorders: GI hemorrhage, hematoma, platelets decreased. Psychiatric disorders:
Anxiety, Insomnia. Red blood cell disorders: Anemia. Respiratory system disorders:
Pneumonia, Sinusitis. Skin and appendage disorders: Eczema, Skin ulceration. Urinary system disorders: Cystitis. Vision disorders: Cataract, Conjunctivitis.
Other potentially serious adverse events which may be of clinical interest but were rarely
reported (<1%) in patients who received PLAVIX in the CAPRIE or CURE controlled clinical
trials are listed below regardless of relationship to PLAVIX. In general, the incidence of these
events was similar to that in patients receiving aspirin (in CAPRIE) or placebo + aspirin
(in CURE).
Body as a whole: Allergic reaction, necrosis ischemic. Cardiovascular disorders: Edema generalized. Gastrointestinal system disorders: Gastric ulcer perforated, gastritis hemorrhagic,
upper GI ulcer hemorrhagic. Liver and Biliary system disorders: Bilirubinemia, hepatitis infectious, liver fatty. Platelet, bleeding and clotting disorders: hemarthrosis, hematuria, hemoptysis, hemorrhage intracranial, hemorrhage retroperitoneal, hemorrhage of operative wound,
ocular hemorrhage, pulmonary hemorrhage, purpura allergic, thrombocytopenia. Red blood
cell disorders: Anemia aplastic, anemia hypochromic. Reproductive disorders, female:
Menorrhagia. Respiratory system disorders: Hemothorax. Skin and appendage disorders:
Bullous eruption, rash erythematous, rash maculopapular, urticaria. Urinary system disorders: Abnormal renal function, acute renal failure. White cell and reticuloendothelial system
disorders: Agranulocytosis, granulocytopenia, leukemia, leukopenia, neutrophils decreased.
Postmarketing Experience
The following events have been reported spontaneously from worldwide postmarketing
experience:
• Body as a whole:
-hypersensitivity reactions, anaphylactoid reactions, serum sickness
• Central and Peripheral Nervous System disorders:
-confusion, hallucinations, taste disorders
• Hepato-biliary disorders:
-abnormal liver function test, hepatitis (non-infectious), acute liver failure
• Platelet, Bleeding and Clotting disorders:
-cases of bleeding with fatal outcome (especially intracranial, gastrointestinal and
retroperitoneal hemorrhage)
-thrombotic thrombocytopenic purpura (TTP) – some cases with fatal outcome(see WARNINGS).
-agranulocytosis, aplastic anemia/pancytopenia
-conjunctival, ocular and retinal bleeding
• Respiratory, thoracic and mediastinal disorders:
-bronchospasm, interstitial pneumonitis
• Skin and subcutaneous tissue disorders:
-angioedema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal
necrolysis, lichen planus
• Renal and urinary disorders:
- glomerulopathy, increased creatinine levels
• Vascular disorders:
- vasculitis, hypotension
• Gastrointestinal disorders:
- colitis (including ulcerative or lymphocytic colitis), pancreatitis, stomatitis
• Musculoskeletal, connective tissue and bone disorders:
- myalgia
OVERDOSAGE
Overdose following clopidogrel administration may lead to prolonged bleeding time and
subsequent bleeding complications. A single oral dose of clopidogrel at 1500 or 2000 mg/kg
was lethal to mice and to rats and at 3000 mg/kg to baboons. Symptoms of acute toxicity
were vomiting (in baboons), prostration, difficult breathing, and gastrointestinal hemorrhage in all species.
Recommendations About Specific Treatment:
Based on biological plausibility, platelet transfusion may be appropriate to reverse the
pharmacological effects of PLAVIX if quick reversal is required.
DOSAGE AND ADMINISTRATION
Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
The recommended daily dose of PLAVIX is 75 mg once daily.
Acute Coronary Syndrome
For patients with acute coronary syndrome (unstable angina/non-Q-wave MI), PLAVIX
should be initiated with a single 300 mg loading dose and then continued at 75 mg once
daily. Aspirin (75 mg-325 mg once daily) should be initiated and continued in combination
with PLAVIX. In CURE, most patients with Acute Coronary Syndrome also received heparin
acutely (see CLINICAL STUDIES).
PLAVIX can be administered with or without food.
No dosage adjustment is necessary for elderly patients or patients with renal disease. (See
Clinical Pharmacology: Special Populations.)
Distributed by:
Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership
New York, NY 10016
PLAVIX® is a registered trademark of Sanofi-Synthelabo.
Brief Summary of Prescribing Information Revised February 2006
PLA-FEB06-B-Aa
YOU DON’T
WANT ANOTHER
HEART ATTACK
OR ANOTHER
STROKE
TO SNEAK UP
ON YOU.
WITHOUT PLAVIX
PLAVIX HELPS KEEP BLOOD PLATELETS
FROM STICKING TOGETHER AND FORMING
CLOTS, WHICH HELPS PROTECT YOU FROM
ANOTHER HEART ATTACK OR STROKE.
If you’ve had a heart attack or stroke, the last thing you
need is another one sneaking up on you. PLAVIX may
help. PLAVIX is a prescription medication for people who
have had a recent heart attack or recent stroke, or who
have poor circulation in the legs, causing pain
(peripheral artery disease).
PLAVIX OFFERS PROTECTION.
PLAVIX is proven to help keep blood platelets from
sticking together and forming clots, which helps keep
your blood flowing. This can help protect you from
another heart attack or stroke.
IMPORTANT INFORMATION: If you have a stomach
ulcer or other condition that causes bleeding, you
shouldn't use Plavix. When taking Plavix alone or with
some medicines including aspirin, the risk of bleeding
may increase.To minimize this risk, talk to your doctor
before taking aspirin or other medicines with Plavix.
Additional rare but serious side effects could occur.
WITH PLAVIX
TALK TO YOUR DOCTOR ABOUT PLAVIX.
For more information, visit www.plavix.com or call
1-800-609-7515
PROVEN TO HELP PROTECT FROM
ANOTHER HEART ATTACK OR STROKE
© 2006 Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership.
USA.CLO.06.03.81/March 2006
B1-K0238/03-06
sanofi-aventis U.S. LLC
NON-PROFIT ORG.
U.S. POSTAGE PAID
PERMIT NO. 4
LONG PRAIRIE, MN
National Center
7272 Greenville Avenue
Dallas, TX 75231-4596

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