After - American Stroke Association

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contents
September/October 2005
“Infinity 102”
Feature Story
The Art of Recovery 18
Painting is a gift in the lives of these survivors.
Articles
When the Eyes Don’t Have It 14
Vision problems after stroke
Boomers’ Health — Boom or Bust? 24
Everyday Choices can reduce many risks.
18
From Singing to Speaking 26
An innovative program for speech recovery
Solomon’s Birthday 28
Party plans are ruined but a
backup plan works wonders.
Departments
3
Stroke Notes 4
Readers Room 8
Everyday Survival 30
Letters to the Editor
14
28
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 2005 American Heart Association ISSN 1047-014X
Ellen Magnis, 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 or advertising 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)
Sam Gaines, 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.
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.
WITH PLAVIX
TALK TO YOUR DOCTOR ABOUT PLAVIX.
For more information, visit www.plavix.com or call
1-877-700-0701.
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
PROVEN TO HELP PROTECT FROM
some medicines including aspirin, the risk of bleeding
ANOTHER HEART ATTACK OR STROKE
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.
Please see important product information on the following page.
© 2005 Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership.
USA.CLO.05.04.41/May 2005
B1-K0180/05-05
Sanofi-Synthelabo Inc., a member of the sanofi-aventis Group
PLAVIX®
clopidogrel bisulfate tablets
Rx only
Brief Summary of Prescribing Information Rev. November 2004
INDICATIONS AND USAGE
PLAVIX (clopidogrel bisulfate) is indicated for the reduction of thrombotic 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 and requires urgent referral to a hematologist for prompt treatment. It is
characterized by thrombocytopenia, microangiopathic hemolytic anemia (schistocytes
[fragmented RBCs] seen on peripheral smear), neurological findings, renal dysfunction, and fever. TTP was not seen during clopidogrel's clinical trials, which included
over 17,500 clopidogrel-treated patients. In world-wide postmarketing experience,
however, TTP has been reported at a rate of about four cases per million patients
exposed, or about 11 cases per million patient-years. The background rate is thought
to be about four cases per million person-years. (See ADVERSE REACTIONS.)
PRECAUTIONS
General
As with other antiplatelet agents, 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).
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 that they may bleed more easily and it may take them longer than
usual to stop bleeding 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 bleeding events with clopidogrel plus aspirin versus
placebo plus aspirin by age category is provided in the following table (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 below). 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 the table below for patients receiving both PLAVIX and aspirin in CURE,
CURE Incidence of bleeding complications (% patients)
P-value
Event
PLAVIX
Placebo
(+ 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 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 (clopidogrel bisulfate) 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
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.
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)
Adverse Events Occurring in �2.5% of PLAVIX Patients in CAPRIE (continued)
Body System
PLAVIX
Aspirin
Event
[n=9599]
[n=9586]
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.
Adverse Events Occurring in �2.0% of PLAVIX Patients in CURE
Body System
PLAVIX
Placebo
(+ aspirin)*
(+ aspirin)*
Event
[n=6259]
[n=6303]
Chest Pain
2.7 (<0.1)
2.8 (0.0)
Central & peripheral nervous system disorders
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 Wholegeneral 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
• Central and Peripheral Nervous System disorders:
- confusion, hallucinations, taste disorders
• Hepato-biliary disorders:
- abnormal liver function test, hepatitis (non-infectious)
• Platelet, Bleeding and Clotting disorders:
- cases of bleeding with fatal outcome (especially intracranial, gastrointestinal
and retroperitoneal hemorrhage)
- agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic
purpura (TTP) - some cases with fatal outcome – (see WARNINGS).
- conjunctival, ocular and retinal bleeding
• Respiratory, thoracic and mediastinal disorders:
- bronchospasm
• Skin and subcutaneous tissue disorders:
- angioedema, erythema multiforme, Stevens-Johnson syndrome, lichen planus
• Renal and urinary disorders:
- glomerulopathy, increased creatinine levels
• Vascular disorders:
- vasculitis, hypotension
• Gastrointestinal disorders:
- colitis (including ulcerative or lymphocytic colitis), pancreatitis
• Musculoskeletal, connective tissue and bone disorders:
- myalgia
OVERDOSAGE
Overdose following clopidogrel administration may lead to prolonged bleeding time
and subsequent bleeding complications. Appropriate therapy should be considered if
bleeding is observed. 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.
L E T T E R S
editor
to the
Con n e c t i n g Yo u t o Us
I picked up the March/April 2005 issue at
the neurologist’s office and was very impressed by Mary
Morgan’s article, “The View from in Here.” It was well
written and insightful. I plan to buy her book.
I am 41 and have developed “essential tremor,” which
has compromised many of my interests and talents. Her
remarks about bidding a former self good-bye hit home
strongly. I have also had to do this. Even though I have not
had a stroke, her words helped me greatly.
Your March/April 2005 issue is (as
usual) full of terrific articles. I especially enjoyed “The View
from in Here” and “20 Things my Stroke Taught Me.” This
issue is surpassed only by the January/February 2004 issue.
Okay, so I’m a little biased!
Santino “Mags” Magnano, Survivor
Middletown, Connecticut
Editor’s Note: “A Common Bond” in our January/February 2004 issue
featured Santino and his son-in-law Greg.
Kathy Wong
Waterford, Michigan
The remnant of my stroke is left-side
“The View from in Here”
in the March/April 2005 issue struck a note with me.
I had a stroke in April 2003, and my physical recovery
has been good. Psychologically I still have a way to
go. People, even close friends, rarely assess or inquire
beyond the physical. I find that people primarily relate to
my physical recovery and have little understanding that
the “stroke had also damaged and shattered my mind,” as
Ms. Morgan said. My current reality is also like hers, “a
lonely, dark, empty place.” I, too, often ask, “Is this what
losing your mind feels like?”
So thank you, Mary, for putting your thoughts on
paper and letting me know that I am not “unique to this
craziness.” I will continue to try to stay as upbeat as my
condition will allow. I relish the company of others, but I
have learned to appreciate my solitary life and “the view
from in here.”
Ron Williams, Survivor
Dana Point, California
I totally relate to E.E. Hawks in the May/
June 2005 issue. Caregiving is the hardest and loneliest
job I have ever had. There were times that the only help I
had was reading Stroke Connection. Your magazine helped
me see a light at the end of the tunnel.
Support groups are great in theory, but in reality, the
rare time you have to yourself is spent taking care of your
personal business or catching up on sleep. Thank you so
much for printing that letter. Once again, your magazine
has assured me that I am not alone.
Anne Dimiceli, Caregiver
Finksburg, Maryland
paralysis. I can accept that restriction and have learned to
function quite handily with my right side. Still, it’s a nuisance
I’d like to eliminate.
My stubbornness and persistence were actually assets in
my recovery. However, one thing sticks in my craw, and that
is the recovery possibilities revealed to me after my medical
coverage had expired.
During a community re-entry program I learned from
fellow survivors of cutting-edge treatments that made the
care I received through my veteran’s benefits seem positively
stone age. Although I received quality care, it was merely
maintenance-oriented that did not address the possibility
of marked improvement. I have researched therapies and
treatments that could offer significant improvement.
My problem is limited resources. When I contacted
my doctor’s office about the cost of such therapy, they
suggested I approach my church. I rejected this because
they had already helped my family and I cannot impose
on them anymore. I have begun researching ways to get
this treatment without impacting my family financially, but
have yet to find anything. Consequently I am peering at a
row of barricades in my path to recovery.
J. LeRoy Ziemer, Survivor • Via e-mail
Editor’s Note: We welcome any suggestions from readers for financing
treatments not covered by insurance.
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
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Con n e c t i n g Yo u t o t h e Wo r l d
More Developments
in ‘Bionic’ Implants
A
46-year-old stroke survivor has become the first
person to have multiple “bionic” implants fitted
to help restore movement in her hand and arm.
Fran Read of Poole in Dorset, England, underwent
the pioneering procedure recently at Southampton
General Hospital. Read, a hairdresser, hopes she will
be able to return to playing volleyball.
Five tiny electrical micro-stimulators (called
BIONs for BIOnic Neurons) were implanted into
Read’s upper arm and forearm close to nerves and
muscles that she has not been able to use since her
strokes. Two weeks after the surgery, she was fitted
with a radio frequency cuff that relays signals from
a computer and to the micro-stimulator. The microstimulators receive instructions that will mimic
messages the brain usually sends to the muscles.
Similar devices have been implanted in the arms
and shoulders of patients in the United States, Canada
and Japan, but they included only a single stimulator.
(For more, see “Rehab Advances” on p. 13 in our
July/August 2005 issue.)
“Everything seems to have gone well, and the latest
procedure is a success,” said Dr. Jane Burridge, leader
of the project at Southampton General. She said she
hoped the limb would rebuild its muscles and relearn
how to move.
DEEP BRAIN STIMULATION EASES CHRONIC PAIN
D
eep brain stimulation (DBS) may help people with chronic pain
who haven’t responded to other forms of treatment, according
to an Australian study presented to the American Association of
Neurological Surgeons at its annual meeting in New Orleans in April 2005.
DBS, used for more than 50 years to treat chronic pain, involves placing
electrodes into the brain to deliver a continuous electrical pulse to areas
that process pain signals.
The Australian researchers found that the rate of long-term pain
relief was highest – 87 percent – in patients receiving DBS in the brain’s
periventricular gray region and the sensory thalamus. Patients who had
permanent DBS implantation for uncontrolled low back pain and failed back
surgery received long-term relief in more than 80 percent of the cases.
Permanent DBS implantation relieved pain in 58 percent of stroke patients.
“We conclude from this analysis, as well as our own experience, that
DBS has an important role to play in the treatment of selected patients
with chronic pain syndromes that have not responded to other forms of
treatment,” said Dr. Richard G. Bittar of the Australasian Movement Disorder
and Pain Surgery Clinic in Melbourne, Australia.
4
5
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Con n e c t i n g Yo u t o t h e Wo r l d
Vibrating
Bubbles
Eliminate
Blood Clots
N
ew clinical trials are testing the effectiveness of treating
acute ischemic stroke with nanotechnology. Nanotechnology
is an emerging field based on the manipulation of tiny
structures. It can have various useful applications, including the
treatment of diseases. ImaRx Therapeutics, Inc., of Tucson, Ariz.,
is using its own treatment method, SonoLysis, which combines
ultrasound and the company’s nanobubbles to clear blood clots
quickly without surgery or clot-busting drugs such as t-PA.
ImaRx’s nanobubbles are injected intravenously to accumulate
at the site of a blood clot. When ultrasound is applied, the bubbles
are designed to pulsate and break apart, destroying the clot.
Aside from aspirin, the FDA has approved only two treatments
for stroke: the MERCI Retriever and t-PA. The MERCI Retriever,
a corkscrew-like device, is inserted into the artery to extract blood
clots from brain arteries in patients suffering an acute ischemic
stroke. The drug t-PA breaks down clots and can be used only
within the first three hours following a stroke.
The trial results will build on an earlier study at the University
of Texas Health Science Center at Houston that set out to
determine whether ultrasound could safely enhance the clotdissolving ability of t-PA.
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7
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Con n e c t i n g Yo u t o O t h e r s
One for Grandfather,
One for Me
L
ast year during track season my grandfather,
Charles Bostic, was always there to support me.
No matter how I did, he was always proud of
me. Even if I got dead last he would tell me I did
great, even though we both knew I did horrible.
He always tried hard to get to my meets, and if he couldn’t, he
would have me call him on a cell phone after every race and tell
him how it went. Time was never an issue, he always had time
to support me.
Then my grandfather had a stroke while sleeping. No one,
including him, knew until the next morning. In the morning, his
mouth was drawn to one side, he didn’t know where he was,
and he felt very clammy. His memory was foggy, too. So my
grandmother took him to the doctor. The doctor ran some tests
and told my grandmother that he had had one large stroke and
at least two small ones. This news upset my whole family.
The doctor said my grandfather would probably never be
able to do anything a normal person could. This was horrible
because it meant he would not be able to coach me or come to
any of my track meets. I began concentrating more on helping
him with his physical therapy and less on track. But he didn’t
want me to stop focusing on track, so I promised to focus on it
as long as he would focus on getting better.
As track season drew to an end, my grandfather was slowly
improving. Visiting him, I promised I would make it to the state
championship meet and that I would dedicate the meet to him.
I advanced to the state meet in the relays. I immediately
called my grandfather and was like: “I made it! I really made
it!” My grandfather was able to come to the meet, and my relay
team took fourth place overall. Amongst the crowd that roared
when we stood on the podium to receive our medals was my
grandfather, who was so proud of me. But he was not as proud
as I was of him because of the amazing comeback he made
from his strokes.
He told me he got better because of me. I felt the same way
about going to state. Making it to that meet was all for my
grandfather. To this day, he is still here for me, and I am still
here for him. I guess we were just what each other needed. He
will always be my hero.
Crystal Wade, 15-year-old granddaughter
Gallipolis, Ohio
8
Top: Crystal and her grandfather Charles Bostic;
bottom: Charles, physical therapist Lia Bartee and
Crystal at the rehab center
9
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Grandmother’s
Wisdom
S
troke became my
reality in April 2003
at the age of 46.
After two weeks
without a diagnosis, I
was informed that I had, indeed,
had a stroke and needed surgery.
Today I have two implants to
close a flap on my heart, which
probably caused my stroke, in
addition to taking hormones.
Three months later, I
decided to attend college as a
full-time student and achieve
my life-long dream of earning a
degree and becoming a teacher.
At the beginning of every day
I am thankful for being alive.
As a child I learned this lesson
from my grandmother’s blessed
words, “Only for the grace of
God, go I”– and they became
my driving force through
recovery.
In January 2005, my
husband Mark and I supported
our daughter Sarah as she
ran a half-marathon for
Philadelphia’s Train To End
Stroke (TTES) team. It was
Top: Susan Catalano; bottom: daughter (and marathoner) Sarah Catalano
an awesome experience. Her
the race, runners read the words out loud and shared
determination to raise money for stroke awareness
in their inspiration. I was touched to find that she had
became extremely important after my stroke. We
also written “For My Stroke Hero: My Mom” just
did a lot of research and found that it is common for
above those words.
women like me to be misdiagnosed simply because
She has filled me with pride, as well as honored
of our age and good physical condition. We want to
and
inspired me and others through her dedication as
educate women of every age about the warning signs
she trained.
of stroke.
Before the race, Sarah printed my grandmother’s
Susan Catalano, Survivor
wisdom on her TTES shirt: “Only for the grace of
Lodi, New Jersey
God — go I.” Afterwards she told us that throughout
10
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Spunky Attitude
L
ast July I fell and broke four ribs. They were healed by
September, and believe me, I pick up my feet when I walk now.
After the fall, I began walking in the house. I have a route
laid out. I walk it and then rest a minute, then walk again, thus
keeping my pulse rate up. It takes one hour to walk the house nine times.
Sometimes I become discouraged and question just how far I can go
toward recovery at age 84. Then I kick and get up to walk and exercise,
knowing I won’t get better sitting in my chair!
The stroke in 2001 slowed me down a whole heap! I still call friends
to meet for coffee once a month. And I set up a breakfast meeting once a
month with other friends.
My husband Wayne and I play bridge with friends once a week. We
go out to eat many days. I am so lucky to have a husband that takes me
out. I couldn’t do it on my own because of partial loss of my eyesight.
Lorraine Essig, Survivor • Loveland, Colorado
Lorraine and Wayne Essig
BEFORE IT’S ABSOLUTELY NECESSARY
J
ust what is it about the need to use
a mobility device that throws so
many otherwise intelligent people
into a tizzy when it becomes apparent
that they need one to get around?
It’s been 10 years since a massive
hemorrhagic stroke almost killed me. I
was told that I would never walk, talk or
work again. Six months after those words
were spoken, I returned to work. It was
really tough, however, to get from point A
to point B. Walking was a real chore, and I
frequently had to sit down, so I asked my
doctor about mobility assistance.
Being able to move quickly from car
to office was the only consideration I had.
I could care less what others think of me,
I just need to be able to move around
without falling down or blacking out.
Today, when people ask me why I
am in a wheelchair – actually I use a
power chair – I tell them because I have
FDGB Syndrome: Fall Down Go BOOM!
They get a good laugh and so do I. I
have never had anyone make fun of me
or look down on me because I chose
mobility assistance instead of becoming
a “cripple” or a burden on others. Yes, I
have had some people try to ignore my
presence, but once they see me smiling at
12
them, they just smile back and say hello.
I drive my own automobile, and in
the past few years I’ve driven to Las
Vegas, New Orleans, Indianapolis and
other far-flung cities. I take commonsense precautions, like making sure my
vehicle is roadworthy before leaving. I love
driving. When I arrive at my destination, I
have my Jazzy in the back of the van and
can do pretty much whatever I please.
It upsets me to see people refuse
mobility assistance because of this
attitude: “I won’t use it until it becomes
absolutely necessary.” Their obstinacy
is jeopardizing their health and their
family’s welfare because once it’s
“absolutely necessary,” they’ve lost
the ability to walk and have become
a burden to their caregivers. What a
senseless, selfish waste!
Because I chose to use mobility
assistance, I have extended my ability
to walk indefinitely. I use my power chair
when I am out in public – shopping,
working or just having fun. That has
allowed me to preserve my strength for
walking around my home. But when I’m
weak, I have no second thoughts about
getting my Quickie Revolution or asking
a family member to get it for me. I’m not
stupid, I refuse to hurt myself and frighten
my family because I’m too proud to use
my “round legs.”
With the variety of new and used
mobility devices available to disabled
people, and the accessibility that is
currently available (not that more couldn’t
be done, but that’s another story), there
should be no excuse (except financial)
for people not being as mobile and
independent as they can. You should
do this as soon as it becomes obvious
that even part-time assistance would
enhance your ability to function more
independently.
For any survivor who is employed
at the time of the stroke, I advise you
to purchase a device at once if you can
because you don’t know when you will
have to quit work and lose your insurance
coverage. I worked for nearly 18 months
after my stroke and then had to retire
because of a drug-related impairment. By
then, however, I already had my chair.
Beverly Kurtin, Ph.D., Survivor
Hurst, Texas
Editor’s Note: For more on mobility devices, see
Everyday Survival, p. 28.
An Angel Makes Her Rounds
N
ovember 12, 1999, I woke up feeling as good as ever and went out to
the kitchen to make coffee. I got out my medication and went to the
back porch. As I stepped onto the porch, I fell flat on my back and broke
my right leg and arm.
My husband has a hearing problem, and besides, he was asleep in the back of
the house, so I couldn’t get him to hear me. So I asked God to wake him, and he
came to the door in about two minutes. Ten minutes later I was being put into the
ambulance and taken to the hospital. The last thing I knew was my son and his wife
were by my bed.
My doctors told my family that I could not live more than four days, and if I
lived I would be a vegetable and not know anything. Later a lady came into the
room where my family was, and she asked where I was. My son took her down
the hall and showed her into my room. He said she prayed a prayer like he had
never heard, and then she went her way and he went his. Nobody knew her, but I
began to get better.
I have served God about 50 years, so He didn’t forget me: He sent an angel to me.
Lera Hagadorn, Survivor • Birmingham, Alabama
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BY JON CASWELL
any survivors have vision problems after stroke, ranging from dry eyes
to double vision to loss of visual field. The problems vary depending on
where the brain injury occurred.
Frequently these problems are hidden and neglected, which lengthens
or compromises rehabilitation.
Vision is much more than eyesight, which is called visual acuity. Vision is the process of
deriving meaning from what is seen. This is a complex process, and many of its components
are learned and develop over time. Some experts estimate that our vision is involved in up to 85
percent of our perception, learning and the mental acquisition of knowledge (cognition). The
ultimate purpose of the visual process is to arrive at an appropriate motor or cognitive response.
Below are some of the most common visual problems associated with stroke.
LOSS OF VISUAL FIELD (HOMONYMOUS HEMIANOPSIA)
There are many types of visual field loss after stroke, but the most common form is the loss
of half of the field of vision in each eye. Damage to the back of the brain on one side results
in loss of the visual field on the opposite side in both eyes. Patients often mistakenly believe
that the loss is only in one eye. This two-eyed problem is commonly called a “cut” because the
visual field appears to be cut in half.
Visual field loss is both disconcerting and dangerous. Survivors with a field cut can easily
bump into or trip over objects within the field loss. Crowds sometimes prove challenging
14
because people suddenly appear from their blind side.
Some survivors fear leaving home, while others have
difficulty reading.
Visual field loss is treated with special visual field
awareness prism lenses. As the patient scans into the
prism the optics shift to increase the perceptual field by
about 15 to 20 degrees. Since double vision occurs when
scanning into the prism, the patient can only look through
it briefly.
These prism lenses are used only as spotting devices
to determine if there is an object in the periphery that
deserves further visual attention. When such an object
is spotted, the patient turns his or her head to view it
in detail with their intact central vision. Scanning, or
learning to look from side to side, is another technique
used to cope with visual field cuts.
VISUAL NEGLECT
Damage to certain areas of the brain may result in
failure to appreciate space to one side, generally to the
left. This is called visual neglect, visual imperception
or hemispatial agnosia. Unlike field cuts, which are
caused by physical loss of sensation, neglect is a passive,
unconscious, decreased awareness of part of the field of
view or other stimuli to one side of the body.
For instance, a man with left-side neglect may not
shave that side of his face. Neglect caused by an injury to
the right side of the brain is usually more severe than that
resulting from a left-brain injury. Field cuts and neglect
may occur together, but those with neglect have more
difficulties than those with field cuts only. Those with a
field cut only are more likely to compensate.
Treatment options for visual neglect are limited. It
begins with teaching the survivor to be aware of the
neglected side, often through occupational therapy. If the
person also has a visual field defect, the lens mentioned
earlier may help, especially when used with intense
occupational therapy.
Like neglect, other problems, such as difficulty
navigating or misjudging the straight-ahead position
or confusing right and left, are also considered spatial
disorders and may occur after stroke.
VERTIGO, DIZZINESS AND
IMPAIRED EYE MOVEMENTS
In order to read, track objects and compensate for body
movements, the eyes must move smoothly and accurately.
However, after a brain injury, eye movements may
become jerky. This is called nystagmus and may cause the
survivor to feel like the world is moving, or experience
other vertigo-like sensations. This happens because the
brain does not register that it is the eyes that are shaking.
Rather, the brain interprets that it is the world and objects
15
even eye-muscle surgery. However, surgery may not be
considered initially because some patients recover function
over time, using the other methods. When double vision
causes significant discomfort, and does not respond to
other therapies, occlusion may be used. This used to mean
black “pirate” patches over one eye, but new methods
of occlusion are now available. They include prisms and
semi-opaque occlusions as well as small-spot occlusions
that may block only a centimeter of vision but prevent the
problem. The use of mirror occlusion eyewear allows a
patch to be hidden
DRY EYES
in it that are moving. This is called oscillopsia and will
frequently cause dizziness and balance problems.
Treatment is first aimed at correcting the underlying
cause of the jerky eye movements or tracking problems.
Neuro-optometric rehabilitation may also help. For
instance, head position and direction of gaze may help
compensate for the sensation of moving by finding a null
point where the jerky movements are decreased. In some
instances tape is used to block part of the glasses lens.
This tape can either improve or block peripheral
stimulation, depending on where the tape is placed.
DOUBLE VISION
Double vision is among the most disorienting and
devastating vision disorders. Survivors with double vision
often go to great lengths to alleviate the double image
because it is so bothersome. Some will actually cover an
eye and eliminate the vision from one eye just to get rid
of double vision. It may be constant or intermittent, or
the survivor may have single vision when looking straight
ahead but double vision to the side.
The cause of double vision is the failure of both eyes
to focus on precisely the same point. One eye actually
turns out, in, up or down compared to the other eye. The
overall term for this is strabismus. It disrupts reading,
walking and other common activities. The disorientation
from double vision will frequently trigger dizziness and
balance problems.
Treatment is varied and may include any combination
of lenses, prisms, therapy, partial selective occlusion and
16
Eyelids work much like the windshield wipers on a
car. The lids clean the cornea by wiping it and constantly
restoring a new film of tears. If the cornea is not kept
moist, a dry eye develops. It is much like chapped lips and
leads to dry, burning, gritty eyes.
After stroke, the rate of blinking may slow, and the
completeness of the blinks may decline. The survivor
may be making only occasional, partial blinks. This
causes the lower portion of the cornea to dry out and
become uncomfortable.
The simple addition of artificial tears, along with
reminders to the patient to blink fully, frequently can
manage this problem. In severe cases, silicone tear duct
plugs may be inserted to reduce the loss of tears down the
normal draining tubes, like putting a stopper in a bathtub.
The result is more tears in the eye.
LIGHT SENSITIVITY
Increased light sensitivity and general inability to
tolerate normal glare sometimes accompanies stroke.
The brain loses its ability to adjust to various levels of
brightness, similar to a radio without volume control to
alter loudness. At this time, tinted eyewear, particularly
amber lenses, is the most effective treatment.
Stroke can affect vision in a variety of ways, from
the loss of sensation to jerky eye movements and double
vision to compromising the capacity to derive meaning
from the written word. Diagnosis is tricky and should
be performed by a doctor skilled in both low vision
and brain injury. Rehabilitation may seem slow, but
any recovery of normal vision pays happy dividends in
independence.
FOR MORE INFORMATION...
on any of these vision problems,
visit the Web site of the NeuroOptometric Rehabilitation
Association at www.nora.cc.
Please send to:
Planned Giving Department
7272 Greenville Avenue
Dallas, TX 75231-4596
send me the free booklet When the Time
Comes. (CCA)
�� 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)
�� Please
When the time comes for
one of you to carry on.
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].
Name
Address
City
State
ZIP
Phone
Birthdate
E-mail
IAD SC 09/05
06CPGDA
LS-0620
A350 Planned Giving 1
8/8/05 12:39:03 PM
17
F E A T U R E
The Art of Recovery by Jon Caswell
The Answer
to ‘Why Me?’
“I discovered there is an answer to the
question ‘Why me?’ — but it lies deep within
yourself, and you have to search it out.”
18
Before
he became a painter,
Monty Shulberg made
his living with his ears.
As a hearing aid audiologist, he had made a happy career
treating children and adults all over the world for hearing
disorders. He was 68, at the top of his profession, and
looking forward to going to work every morning.
Then, in 1997, he was diagnosed with a brain tumor
that required surgery. Though the tumor was removed,
there were significant post-operative consequences:
facial palsy, balance problems, difficulty eating, loss of
manual dexterity and lack of spatial awareness. “Life as I
knew it was finished,” he said.
For the next four years, Monty battled to recover.
He estimates that he got back 90 percent of what had
been lost. Then in March 2001, he felt an odd tingling
in his right hand and foot, and when he stood up, he
collapsed.
It was a stroke, and it changed everything. “I was
shattered,” he said. “I just couldn’t believe that after
nearly four years of slow recovery, I was back where
I started.” The stroke had affected his right side and
brought back the balance problems and facial palsy as
well as problems in closing his right eye. He also became
deeply depressed.
“I felt helpless, hopeless and frustrated because there
was so much more I still wanted to do with my life, but
how on earth was I going to do it? ‘Why me?’ became
the question of the hour.”
In the midst of this moping, “my wife Victoria
challenged me: ‘Do something, anything, take up
drawing, but don’t just sit there!’ And that’s how my
new life began.”
He visited a library and checked out as many books
on art techniques as he could find. He went home and
traced pictures out of them, then he started drawing on
his own, and eventually painting with watercolors. He
could see himself growing in the work, which was the
beginning of self-motivation.
“One day I was trying to think of a subject to paint, when anger
and frustration welled up in me, and I wanted to strike out violently
on a canvas. I slashed vivid colors across it and caught myself
saying again and again, ‘Why me? Why me?’
“Of course, no one else can tell you why. I realized that life isn’t
fair,” he said. “There’s no one to complain to. A better question
would have been,‘Why not me?’ After all, I’m no different than
anyone else.”
Calming down as he painted, he found himself asking if there
were something to learn from the stroke. “I started searching my
mind as I painted – as I had never painted before – and I realized
that painting was a ‘gift’ that had been given to me to help release
the feelings that were pent up inside. The stroke and my recovery
showed me that life goes on, albeit differently, with limitations, but
you can do things you never dreamed possible.”
During this internal conversation, Monty continued to paint.
His frenetic brush strokes calmed, and he began to see signs of a
painting. He slowly finished the work, which he titled “The Burning
Forest.” “At the end, I was exhausted and emotionally drained, but
I was also at peace with myself. I realized that while I would never
be the same person as before, it was possible that I could now
reveal another facet of my personality, and be a person again.”
Since “The Burning Forest,” Monty has discovered an artist
living inside the audiologist. He is a full-time artist now, mainly
using a computer screen as a canvas, a mouse as a brush and
software as his paints. He is exhibiting in galleries, and dozens
of his digital paintings are available at his Web site. One of his
fantasy images called “Orchidii Monti” was selected for the cover
of a review of contemporary poetry introduced by England’s poet
laureate. A poem Monty wrote about his stroke was also included.
“This has been an exciting time for me,” he said, “going
from the depths of despair to joyful elation, despite the fact that
echoes of the stroke live on. I recently had to have yet another
eye surgery.
“Eventually I discovered there is an answer to the question
‘Why me,’ but it lies deep within yourself, and you have to search
it out. You can stay as you are, accepting what has happened to
you, or you can fight to live another day. After all, you have only
got yourself to battle. Go ahead, give it a go!”
Opposite page: “Abstract.”
This page, clockwise from top: “The Burning Forest,”
“Magenta Oh My Magenta,” “Infinity 103.”
To see more of Monty’s art, visit his online gallery
at www.montysart.co.uk.
19
Painting
through
Self-Doubt
Two
“I know that self-doubt is part of
painting and that if I keep painting,
I’ll find my way through the doubt.”
20
brain stem strokes in 24 hours
can derail a dream-come-true,
but for Alison Bonds Shapiro the
strokes created a life-enriching detour.
At age 55, she was finally fulfilling an ambition to
illustrate a children’s book. She had worked hard to
learn to draw, paint and plan. She had completed
three paintings on a 17-illustration assignment for
Just for Today, a 32-page illustrated children’s picture
book, when the strokes struck.
She tried drawing while still in the hospital. “It
looked like the work of a 3 year-old,” she said. “I
cried. I didn’t know how I would ever be able to fulfill
my dream.”
Unfortunately, not drawing was the least of her
worries. The strokes had left her with limited control
of her left arm and hand. Her eyes wouldn’t focus,
and she was very weak and wheelchair-bound in a
house on a mountain.
Enter Suzanne White, a smart, dedicated therapist
who lived within walking distance. “Suzanne came
twice a week and began getting me out on the
mountain as soon as she could,” Alison said. “She
took me on ‘hikes’ when I was still wearing a brace.
She and I constantly devised ways to challenge the
habituation of the disability.
“The house became a gym; we worked with
whatever we found there. I worked with putty and
clay and rubber bands to strengthen my hands. I
typed because typing forced my fingers to work
independently of one another. I did ‘opposite
sequences,’ closing my left hand as my right hand
opened. I wrote. I drew.
“I also had a lot of acupuncture, massage,
chiropractic and a mind/body integrative technique
called Rubenfeld Synergy. My hands were very
important to me, and I was determined to keep working
them until they could do what I wanted them to.”
She had long been a meditator and continued.
“Through meditation you can build a trust in the
process of life and touch something vaster than your
ego. And the mindfulness that meditation produces is
invaluable when you are learning to walk again.”
Nine months after the strokes, she started
painting. She returned to the fourth illustration and
drew and painted for two months before completing
it. “My heart was in my mouth as I showed it to the
publisher and author. They said it was good enough
to keep trying, but no one really knew if I could do 13
more or how long it would take.”
Three years after the strokes, Just for Today
was finally published by HJ Kramer. Though a
reader would never notice anything, Alison can
see differences between the pre- and post-stroke
illustrations. “The post-stroke paintings are richer.
They have more meaning and symbolism.
“I have been painting since the book and working
on my drawing skills. I can tell I am less judgmental,
more open to ‘mistakes,’ more willing to take risks,
freer. I’m not satisfied unless the work has some
real emotional content. I am more patient. I know
that self-doubt is part of painting and that if I keep
painting, I’ll find my way through the doubt.
“I have learned not to give up. The disability
becomes a habit if you don’t challenge it. You have
to find a reason to keep going and keep challenging
yourself. You have to emphasize your strengths
and have compassion for and patience with your
weaknesses. It takes time and effort, but you’re
worth it.”
Both pages: Several samples of Alison’s illustrations
from Just for Today. The book is available at your local
bookstore or online at Amazon.com.
21
Therapy that
Makes You
Laugh
Elizabeth Cockey uses art to rehabilitate
people’s minds and limbs.
“The most remarkable
thing is touching the
human spirit. When we
let that come out in a
safe place, everybody
gets better.”
For more than a decade she has worked with Alzheimer’s patients and
people living with stroke dementia. She has seen many of these people improve,
and even those who don’t get better long-term had fun in the group art lesson.
Elizabeth is the author of Gertrude’s Cupboard: Recapturing Minds Stolen by
Disease. It’s about using art to treat Alzheimer’s patients.
According to the American Art Therapy Association, art therapy is based
on the belief that the creative process in making art is both healing and lifeenhancing. Through creating and discussing art, and the process of making art
with an art therapist, a person can increase awareness of self.
People involved in art therapy can better cope with illness, disabilities, stress
and traumatic experiences. They can enhance cognitive abilities as well, and
enjoy the life-affirming pleasures of artistic creativity.
Art therapy always involves the making of art, typically painting or drawing,
but sometimes working in clay. “I always work with groups in nursing homes
and retirement communities,” Elizabeth said. “They’ll have me for an hour once
a week, and I see definite progress after as little as 20 hours. It’s a lot more
interesting than squeezing a nerf ball. We paint with non-toxic tempera paint. I
have large classes, 10-15 people, and besides painting, there’s a lot of laughing.”
Elizabeth has worked with a number of people with stroke dementia, which
can occur after a stroke, and said they often improve the most.
In addition to cognitive recovery, Elizabeth has seen patients recover the
use of limbs. “When someone restores the use of an arm, it makes it possible
for them to do their activities of daily living, which makes a big difference to
their caregiver.”
Success in art therapy requires the same motivation that success in other
forms of therapy requires. “It doesn’t happen overnight. It takes a lot of
repetition to create a new neurological pathway,” Elizabeth said. One of the
therapist’s main jobs is to keep people focused, which can be challenging with
dementia patients.
“The most remarkable thing is touching the human spirit. When we let that
come out in a safe place, everybody gets better. Sometimes on the way home,
I’m grateful because I got to spend time with these beautiful souls and help
bring them out.”
For more information on art therapy, visit the Web site of the American Art Therapy Association
at www.arttherapy.org, or e-mail at [email protected]. You can find Elizabeth’s book online at
Amazon.com.
22
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
23
BOOMERS’
HEALTH:
Boom or Bust?
by Mike Mills
he oldest baby boomers will
turn 59 this year. In just six more
years, the leading edge of this
tidal wave will begin to swell the
nation’s over-65 population.
Baby boomers are those born in the
United States from 1946 through 1964.
At about 77 million strong, they make up
the largest demographic group, nearly 28
percent of the population. Early boomers
grew up with the “Mickey Mouse Club”
on television and the Vietnam War. Late
boomers were teenagers when Jimmy
Carter and Ronald Reagan were presidents.
As the wave reaches the year 2030,
boomers will be the majority in a group of
older people that will have doubled in size
since 2000.
It’s not just the future number of older
Americans that has the health community
concerned. People 65 and older today
have more health knowledge than adults a
generation ago, but what boomers do with
that knowledge today will determine how
fit they are when they reach their golden
years. And the consensus is that boomers
aren’t doing a very good job of making
healthy choices.
24
A LONG, UNHEALTHY LIFE?
Combining bad health habits – poor diet, little exercise, high stress
– with today’s longer lifespan could add up to decades of ill health
unless boomers make lifestyle changes now.
Statistics work against even the healthy baby boomers. The
chances of getting some diseases are increasing dramatically as they
approach their 50s and 60s:
• The risk of stroke doubles each decade after a person reaches 55.
• 13 million people ages 45 to 54 have heart disease.
• One in 10 women age 45 to 64 has some form of
cardiovascular disease.
• 77 percent of all cancers are diagnosed in people
age 55 and older.
• About 80 percent of breast cancers occur in women over 50.
• The most common form of diabetes usually develops in adults
age 40 and older and is most common in adults over age 55.
Studies show that these statistics point to a real problem: Many
baby boomers deny the risks they face. For instance, a survey of 1,000
adults by the American Stroke Association in 2003 revealed that most
boomers knew at least one – but not all – of the five major warning
signs of stroke. But a third of those responding weren’t concerned
with stroke, because they mistakenly believed they could do nothing
to prevent it.
A national survey in 2004 of 761 baby boomers, conducted for the
Boomer Coalition and the American Heart Association, concluded
that boomers are so optimistic that they will have a healthy future
that they choose to ignore potential health problems. The survey, “Boomer
Coalition Reality Check: When Boomer Optimism Becomes Reality,”
reported that 76 percent saw themselves as maintaining a healthy weight,
but actually 63 percent were already overweight or obese.
PILING UP RISK
Age is a risk factor for the three major disease categories: cardiovascular
disease (including heart disease and stroke), cancer and diabetes. Annually
they kill more than 1.5 million people and cost the nation more than $600
billion. Heredity, family history and age are risk factors people can’t
control, but other risk factors can be controlled, and they have a lot to do
with whether people get these diseases.
Common risk factors run through the diseases. Heart disease and stroke
often occur in conjunction with high blood pressure, high blood cholesterol
and obesity, and so does diabetes. Physical inactivity contributes to all
three diseases.
Obesity, too, appears in all three and has become a major health concern.
It accounts for about $117 billion in healthcare costs each year. Overweight
people, especially those who eat high-fat diets and shun physical activity,
are more likely to have high blood pressure and high cholesterol
Because risk factors overlap, decreasing the risk of one disease could
decrease the risk of others. For instance, heart disease and stroke become
two to four times more likely for someone who already has diabetes.
POUNDS OF PREVENTION
What can be done about diseases that will shadow baby boomers as
they age? You may not be able to predict your future health, but you can
take steps to lower your risk. It’s as easy as the choices you make – or
don’t make – every day.
Prevention makes up less than 5 percent of national healthcare
expenditures, according to the Centers for Disease Control and Prevention.
That prompted the creation of the “Everyday Choices For a Healthier
Life” program. This is a team effort by the American Cancer Society,
American Diabetes Association and American Heart Association. It
provides information about making better choices. The program focuses
on prevention and early detection of these diseases and has a four-part
message: eat right, become active, avoid or quit smoking and visit a doctor
(see “It’s Your Choice”).
“Everyday Choices” is raising awareness about healthy lifestyles,
encouraging prevention, and supporting legislation to increase funding for
prevention programs and research.
CHANGING COURSE
Once they knew about the dangers of heart attack and stroke, 74 percent
of those participating in the “Boomer Coalition Reality Check” survey said
they were moved to live healthier lifestyles. Most said they would even tell
friends what they had learned about the risks of heart disease, stroke and
other cardiovascular diseases.
The boomers are known as an optimistic, highly educated and proactive
group of people not afraid of change – fertile ground in which accurate
health information can take root. But information is not enough. Change
comes only from choosing a healthy lifestyle, every day, that can lower the
risks of disease now and in the future.
IT’S YOUR CHOICE
Eating Right: Baby boomers are more
overweight than any previous generation.
They also are the first generation to grow
up with fast food. “Everyday Choices”
emphasizes limiting the type of saturated
fats found in fast foods and choosing
more balance in the diet. Guidelines
include:
• Avoiding saturated fats from dairy,
meat and poultry products, and
tropical oils. Consuming healthy fats
such as olive, peanut, soybean and
canola oils.
• Choosing brightly colored vegetables,
fruits, whole grains, low-fat dairy
products and lean meats.
• Keeping portion sizes reasonable.
Being Active: The inactivity habit can
be overcome by taking small steps. You
don’t have to run a marathon to benefit
from activity. Just:
• Walk during a lunch break or
after dinner.
• Slowly increase walking to 30 minutes
a day on five or more days a week.
• Try swimming, gardening, dancing,
biking, hiking or skipping rope.
Smoking: There is no middle ground
about smoking. It’s a killer. If you smoke,
quit. If you don’t smoke, don’t start.
See Your Doctor: Schedule an annual
checkup and find out which preventive
screenings and tests you need and how
often. Your doctor can advise you on how
to lose weight or about anything else
listed above.
For more information about
making healthy choices, visit
www.everydaychoices.org.
25
From
Singing to
Speaking
by Nancy Helm-Estabrooks, Sc.D., CCC-SLP, BC- ANCDS
Member, American Speech-Language-Hearing Association
IT’S
AMAZING TO SE E
stroke survivors who can’t speak suddenly produce
accurate words when singing familiar songs. This
phenomenon was first reported by Swedish physician
Olaf Dalin in 1736. Dr. Dalin described a young man who
had lost his ability to talk as a result of brain damage, but
who surprised townsfolk by singing hymns in church.
The acquired language disorder now called “aphasia”
became a subject of clinical study and a target for
rehabilitation beginning in the mid-1880s. Since that
time, every clinician working with aphasia has seen
individuals who can produce words only when singing.
Indeed, this observation prompted American neurologist
Charles Mills to suggest (in 1904!) that it might help to
play the piano and encourage patients with aphasia to
sing well-known songs.
There appear to be psychological benefits, but singing
familiar songs alone doesn’t seem to improve the speech of
people with aphasia. This is probably because words that
come so automatically when singing are intricately linked
to the melodies and are not easily separated.
26
The spoken word is a different matter. We know
the brain has difficulty starting in the middle of highly
memorized spoken passages (such as the “Pledge of
Allegiance”). We need a “running start” to prime the pump
of recall.
Songs themselves might be used to communicate. I had
a patient who struggled to tell his son he wanted to go to
a Boston Red Sox game. He finally got his point across
by bursting forth with “Take Me Out to the Ball Game.”
Unfortunately, there aren’t appropriate songs for every
communication need, so it would be better if singing could
be used to unblock residual speech abilities. This was the
motivation for the aphasia treatment approach “Melodic
Intonation Therapy,” which we began to develop in 1972.
TRIAL AND ERROR
Robert Sparks, a speech-language pathologist; Martin
Albert, a behavioral neurologist; and I were working on the
Aphasia Unit of the Boston VA Hospital. We saw a woman
whose only purposeful speech were the nonsense syllables
“nee-nee-nah-nah.”
At that time, a hospital volunteer was coming to each
inpatient ward with a piano on wheels and conducting
sing-along sessions with the patients. One day we observed
our patient sitting beside him in her wheelchair and singing
many of the words of popular songs. Though we had seen
this before, this new example convinced us we had to try to
develop a method that capitalized on this preserved ability
to produce speech when singing.
We knew that simply singing familiar songs with
this woman would not do the trick. Through trial and
error, we discovered that if we melodically intoned
everyday phrases such as “open the window” while
helping her tap out the syllables with her unaffected
hand, she could produce phrases in unison with us.
Then she could intone the phrases with just a little
help at the beginning. Finally, she could produce
them on her own.
From this experience, we created a treatment
program using melodically intoned and tapped out
phrases of increasing length. Usually within a few
sessions, patients’ production of nonsense syllables had
disappeared and they began to communicate verbally
in everyday situations. Our continued research helped
identify the best candidates for this method.
WHY DOES IT WORK FOR SOME PEOPLE?
We know that aphasia typically results from a
stroke or other damage that affects the left hemisphere
of the brain, where language ability usually is located.
We thought it might be because a stroke increased
the use of the brain’s right hemisphere, where many
aspects of music and the melody of speech are located.
Using this treatment, the dominance of the damaged
left hemisphere language areas might diminish while
the right hemisphere became more involved.
A recent study using functional magnetic resonance
imaging with individuals treated with melodic
intonation therapy showed that the right hemisphere
does, indeed, play a role in response to this method.
Preliminary results suggest that the amount of speech
recovery may be associated with how much and what
part of the right hemisphere is activated. This study
demonstrates the flexibility of adult brains, even those
with stroke-related damage.
It is encouraging to know that with special
treatment we can learn to use undamaged portions
of our brains to perform “new tricks” – even one as
complicated as speaking.
For more information on aphasia, or to find an ASHAcertified speech-language pathologist in your area,
call ASHA’s HELPLINE at 1-800-638-8255, e-mail
ASHA at [email protected], or visit ASHA on the Web
at www.asha.org
SUGGESTIONS FOR USING MUSIC
WITH PEOPLE WITH APHASIA
1. Singing familiar songs is
psychologically and emotionally
uplifting. Provide opportunities
for individuals with aphasia
to sing their favorite songs. In
addition to purchasing albums,
put together tapes or CDs of their
“all-time” favorites.
It is now possible to legally
purchase and download songs from
the Internet to record on CDs or
any number of digital MP3 players
that store many songs. For more
information on how to do this and
a list of reputable online music
sources, visit strokeassociation.org/
magazine or call 1-888-4STROKE
(1-888-478-7653).
2. Make singing a part of social events
that might otherwise be difficult for
a person with aphasia.
GOOD CANDIDATES FOR MELODIC
INTONATION THERAPY HAVE:
• severely restricted speech that
may be limited to nonsense words
or syllables except when singing
along to popular songs;
• poor ability to repeat words spoken
by others;
• relatively good ability to
understand the speech of others;
• good motivation, cooperation and
attentiveness; and
• a single, left hemisphere lesion that
spares Wernicke’s area (the speech
comprehension center of the brain).
If this seems like a match, survivors should
ask a speech-language pathologist to determine
whether an individual with severely restricted
speech output might be a good candidate for
melodic intonation therapy. The program,
including a manual, videotape and stimulus
cards, can be implemented by family members.
For more information on how to obtain it,
call 1-888-488-7653 (1-888-4STROKE).
27
Solomon’s Birthday
by Catherine Jordan
“I had no way of
knowing I’d face
this crisis, but I
was certain that
if anything ever
ha�ened to me,
Solomon would be
safe and sound.”
28
It
started like any other day for Solomon and me. We
walked a few miles in the morning, then I put on my
paramedic uniform, said goodbye and promised him
a party later that day to celebrate his 5TH birthday.
Solomon is my golden retriever.
Unfortunately, we didn’t have the party because I didn’t go
home for more than two months. Instead, I began a medical
odyssey that few thought I would survive. At the same time,
Solomon began his own great adventure. This is our story – one
of love, determination, beating the odds, and the importance of
having a plan. It began to unfold on October 30, 2003.
I started my paramedic shift by visiting Patricia Manzi, a
fellow dog lover and member of the office staff. We laughed
and joked about Solomon’s birthday and our plans for a party.
We’ve always talked about our dogs and what an important part
of our lives and families they are.
A few hours later I was near death and being rushed into
emergency brain surgery to try to correct a grave medical
condition. I had collapsed at the office when an arteriovenous
malformation exploded, causing a massive brain bleed. A
ruptured AVM is almost always fatal.
I had no way of knowing I’d face this crisis, but I was
certain that if anything ever happened to me, Solomon would
be safe and sound.
I had begun hatching my own unique family care plan
a year before after a colleague was seriously injured on the
job. Fellow paramedic Tim Hayes lost his legs when an 18wheeler slammed into the highway crash scene where he was
treating patients. In the wake of that horrific accident, I grew
increasingly concerned about what would happen to Solomon
if I were injured on the job. I’m single and live alone, so a plan
was pertinent.
I created an elaborate one – and perhaps just as
important – shared it with my family, friends and coworkers. Everyone knew their role in the event of a crisis,
though we never believed the plan would be needed.
As fate would have it, it was activated when I became
the patient and paramedics rushed me to the hospital in
an ambulance. My work partner Bruce knew to break
into my locker and pull out an envelope marked “Patricia
Manzi.” He knew exactly where it would be and how
important it was. Envelope in
hand, he raced to the hospital
and found Patricia and the
others keeping vigil in the
emergency department.
I was in grave condition.
My co-workers were still trying
to reach my family while the
doctors and hospital staff were
rushing me into surgery.
They were having a hard time
locating any of them.
Patricia opened the envelope
Bruce had given her to find
a note from me, house key,
directions to my house and other
important information about
Solomon, including his vet’s
phone number.
Like Bruce, Patricia knew
her assignment, but first she and
other agency staff had to reach
my family. Ironically, Solomon
would help. As the agency’s
director of administrative
services, Patricia is one of the
first people notified when an
employee is in a crisis. She has access to important phone
numbers and family information, but on this day, she
wasn’t getting any answers.
Seeking other numbers, they called Solomon’s vet.
The staff there looked through his entire file and relayed
every emergency number they had ever been given.
Finally, they reached my brother-in-law on a cell phone
number that was buried deep in Solomon’s records.
As my family raced to the hospital, Patricia set off
to rescue Solomon. Armed with the envelope and a
friend for moral support, Patricia retrieved a loving
but confused golden retriever and brought him to a
temporary new home.
It was all part of the plan. Patricia and her husband
David became foster parents and their own goldens,
Gracie and Marla, quickly adjusted to having a new
member of the family.
Meanwhile at the hospital, I survived surgery but still
had a tough road ahead. My family was permitted a short
visit in the recovery room, and one of the first things they
told me was that Solomon was okay and with Patricia.
I spent several weeks in the hospital, much of it in
intensive care. Patricia and others made sure I had routine
updates on “my boy” during the brief visits they were
permitted. Even though I was largely unresponsive, I could
hear their stories.
Solomon and Cathy Jordan; photo by Paige Sheehan
At the Manzis’ house, Solomon was doing very well,
becoming a couch potato and gaining weight rapidly.
During one hospital visit Patricia held my hand and asked
me how many cups of food he got each day.
I squeezed her hand five times, which Patricia thought
was funny. She was thrilled that I had heard her and was
able to react. Solomon had been receiving six cups of food
a day so he immediately went on a diet.
Despite Solomon’s dinner indulgence, my plan worked.
My forethought ensured that I was able to care for my
family even in the face of a significant medical crisis.
As my recovery continued, I spent a few weeks at
a rehabilitation facility and enjoyed brief day trips to
see Solomon and other family. I finally went home,
with Solomon, on New Year’s Day, eight weeks after
his 5TH birthday. Now we have much more to celebrate
together.
29
E V E R Y D A Y
survival
Con n e c t i n g Yo u t o H e l p f u l I d e a s
or stroke survivors who’ve experienced
paralysis or other limitations to their range
of movement, mobility can be a major
issue. Personal mobility vehicles, such
as wheelchairs and scooters, are terrific
solutions for covering short distances. For
longer distances, adaptive equipment for motor vehicles
can make driving possible. Whether you have a shortterm or long-term need, it’s critically important to make
informed decisions to get the right equipment.
Going
Mobile
by Sam Gaines
A Personal Set of Wheels
Manual wheelchairs can be fully customized to your
dimensions and comfort level to match the activities
you engage in. There are models for every conceivable
use, including sports and all-terrain mobility. Survivors
considering a manual wheelchair should have sufficient
upper-body strength and be free of chronic pain enough to
operate a chair easily through the course of a day.
Survivors who need more assistance frequently turn
to scooters or powered wheelchairs. Scooters are best
suited to survivors who have the vision, hearing and depth
perception to operate one safely, as well as the strength to
operate a handlebar and keep an upright seated position.
You should be able to balance reasonably well while
sitting and to move from sitting to standing without help.
Scooters require sufficient upper body range of movement
to operate handlebar steering.
Powered wheelchairs are a better option if you need
help getting into the seat or can’t balance on a seat. If you
don’t have the upper body strength or range of motion to
operate handlebar steering, you are a good candidate for
powered chairs.
Talk with your doctor before you decide on a
device. You’ll need a prescription for whatever mobility
equipment you need. Next a team including your doctor,
an OT or PT; and a rehabilitation technology supplier
(RTS), typically someone who deals in “durable medical
equipment” such as wheelchairs, will identify your needs.
The team will prepare a letter specifying why you need
the equipment. This letter is usually sent to the third-party
payer, such as an insurance company.
Going for Distance
If you need to travel farther, there are many options for
adapting a motor vehicle.
First, consult with your evaluation team to see what
you may need in order to drive safely and legally. Then,
contact your state division of motor vehicles’ office of
driver safety to get information about your state’s laws
concerning disabled drivers. Then get tested by a driver
30
rehabilitation specialist to see if you need any retraining.
You may need a new type of driver’s license.
Once they’ve assessed your needs, your evaluation
team may recommend buying adaptive equipment for
your vehicle, or buying a custom-modified vehicle. Here
are a few questions to consider before exploring your
options:
• If you’re driving: Will you be able to transfer
to a driver’s seat or will you need to drive
from your wheelchair? Will you need special
vehicle modifications to operate your vehicle?
• If you’re a passenger: Can you transfer to a
passenger’s seat, or will you need to ride in
your wheelchair? What are your preferences
for seating position and visibility? There are
several ways to adjust seating for maximum
comfort and accessibility. Floors can be
lowered, and doors and ceilings can be raised
to accommodate almost any needs.
Paying for It
Many healthcare plans, HMOs and other insurance
providers (including Medicare and Medicaid) cover at
least some of the costs. Check your plan to see what
is covered before looking for a suitable wheelchair or
scooter, or adaptive motor vehicle equipment.
A great source for payment answers is an RTS. These
equipment dealers stay informed on payment options.
Some of the larger dealers even have their own funding
specialists to help you.
Some RTS professionals are credentialed through
two trade organizations: the National Registry of
Rehabilitation Technology Suppliers (NRRTS), or the
Rehabilitation Engineering and Assistive Technology
Society of North America (RESNA). Both offer referrals
to RTS dealers that carry credentials and promote the
highest standards for professional, knowledgeable and
trustworthy service.
If worker’s compensation is covering your medical
expenses, it’s important to identify what you need as
soon as possible. Temporary benefits have a termination
date, after which the fund will no longer cover the costs.
Be sure to get a prompt start on your search for what
you need. Ask the insurer what deadlines may exist for
ordering the equipment.
Evaluating Your
Personal Mobility
Needs
Getting a wheelchair usually starts with a
prescription from your doctor. But it’s not a
simple matter of taking the prescription to your
pharmacist to get your wheelchair. Many factors
must be considered. For starters, the University
of Pittsburgh’s WheelchairNet recommends
asking yourself:
• Where will I use my wheelchair most?
• What will I occasionally use my
wheelchair for?
• What kinds of daily activities do I most
want to resume?
• How will I get my wheelchair (and
myself) from place to place?
• How much of the day will I be spending
in this wheelchair?
• How will I transfer from the wheelchair
to other surfaces?
• Who will provide help with my
wheelchair if I need it, and what
features about my wheelchair are
important to them?
• How will I get my wheelchair around
my neighborhood or yard? What kind of
surfaces or slopes are involved?
31
E V E R Y D A Y
survival
Con n e c t i n g Yo u t o H e l p f u l I d e a s
Resources
Wheelchairs and Scooters
Adaptive Vehicle Equipment
WheelchairNet is an online portal provided by
the University of Pittsburgh’s Department of
Rehabilitation Science and Technology. It’s a great
place to start researching all things related to
wheelchairs, scooters and mobility assistance. The
National Institute of Disability and Rehabilitation
Research provided funds to create the site.
Consumers, families, clinicians, manufacturers,
funding resource organizations, case managers and
researchers all contribute articles and news items.
The National Highway Transportation Safety
Administration has published a very informative
brochure, Adapting Motor Vehicles For People
With Disabilities. It introduces you to the process
of buying an adapted vehicle or adapting your
own. The brochure takes you step-by-step
through the process professionals use to help
consumers order the appropriate equipment.
The site features the latest news in adaptive
technologies and easy-to-follow guides on getting a
wheelchair. It’s also provides many links to dealers,
credentialing organizations, researchers and many
more important information sources.
www.wheelchairnet.org
1-888-4-STROKE (478-7653)
Fax: (214) 706-5231
www.StrokeAssociation.org
National Family Caregivers Association
Voice: (800) 896-3650
Fax: (301) 942-2302
www.nfcacares.org
Americans With Disabilities Act (ADA)
Voice: (800) 514-0301
TTY: (800) 514-0383
www.usdoj.gov/crt/ada/adahom1.htm
National Aphasia Association
Voice: (800) 922-4622
Fax: (410) 729-5724
www.aphasia.org
National Rehabilitation Information
Center (NARIC)
(800) 346-2742
www.naric.com
32
DOT Auto Safety Hotline: 888-DASH-2-DOT
(888-327-4236)
www.nhtsa.dot.gove/cars/rules/adaptive
PLAVIX®
clopidogrel bisulfate tablets
Rx only
INDICATIONS AND USAGE
PLAVIX (clopidogrel bisulfate) is indicated for the reduction of thrombotic 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 and requires urgent referral to a hematologist for prompt treatment. It is
characterized by thrombocytopenia, microangiopathic hemolytic anemia (schistocytes
[fragmented RBCs] seen on peripheral smear), neurological findings, renal dysfunction, and fever. TTP was not seen during clopidogrel's clinical trials, which included
over 17,500 clopidogrel-treated patients. In world-wide postmarketing experience,
however, TTP has been reported at a rate of about four cases per million patients
exposed, or about 11 cases per million patient-years. The background rate is thought
to be about four cases per million person-years. (See ADVERSE REACTIONS.)
PRECAUTIONS
General
As with other antiplatelet agents, 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).
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 that they may bleed more easily and it may take them longer than
usual to stop bleeding 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 bleeding events with clopidogrel plus aspirin versus
placebo plus aspirin by age category is provided in the following table (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 below). 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 the table below for patients receiving both PLAVIX and aspirin in CURE,
CURE Incidence of bleeding complications (% patients)
P-value
Event
PLAVIX
Placebo
(+ 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 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 (clopidogrel bisulfate) 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
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
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.
Adverse Events Occurring in �2.5% of PLAVIX Patients in CAPRIE
Body System
PLAVIX
Aspirin
Event
[n=9599]
[n=9586]
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)
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)
Adverse Events Occurring in �2.5% of PLAVIX Patients in CAPRIE (continued)
Body System
PLAVIX
Aspirin
Event
[n=9599]
[n=9586]
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.
Adverse Events Occurring in �2.0% of PLAVIX Patients in CURE
Body System
PLAVIX
Placebo
(+ aspirin)*
(+ aspirin)*
Event
[n=6259]
[n=6303]
Chest Pain
2.7 (<0.1)
2.8 (0.0)
Central & peripheral nervous system disorders
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 Wholegeneral 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
• Central and Peripheral Nervous System disorders:
- confusion, hallucinations, taste disorders
• Hepato-biliary disorders:
- abnormal liver function test, hepatitis (non-infectious)
• Platelet, Bleeding and Clotting disorders:
- cases of bleeding with fatal outcome (especially intracranial, gastrointestinal
and retroperitoneal hemorrhage)
- agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic
purpura (TTP) - some cases with fatal outcome – (see WARNINGS).
- conjunctival, ocular and retinal bleeding
• Respiratory, thoracic and mediastinal disorders:
- bronchospasm
• Skin and subcutaneous tissue disorders:
- angioedema, erythema multiforme, Stevens-Johnson syndrome, lichen planus
• Renal and urinary disorders:
- glomerulopathy, increased creatinine levels
• Vascular disorders:
- vasculitis, hypotension
• Gastrointestinal disorders:
- colitis (including ulcerative or lymphocytic colitis), pancreatitis
• Musculoskeletal, connective tissue and bone disorders:
- myalgia
OVERDOSAGE
Overdose following clopidogrel administration may lead to prolonged bleeding time
and subsequent bleeding complications. Appropriate therapy should be considered if
bleeding is observed. 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.
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.
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.
WITH PLAVIX
TALK TO YOUR DOCTOR ABOUT PLAVIX.
For more information, visit www.plavix.com or call
1-877-700-0701.
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
PROVEN TO HELP PROTECT FROM
before taking aspirin or other medicines with Plavix.
ANOTHER HEART ATTACK OR STROKE
Additional rare but serious side effects could occur.
Please see important product information on the inside page.
© 2005 Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership.
USA.CLO.05.04.76/May 2005
B1-K0186/05-05
Sanofi-Synthelabo Inc., a member of the sanofi-aventis Group
NON-PROFIT ORG.
U.S. POSTAGE PAID
PERMIT NO. 4
LONG PRAIRIE, MN
National Center
7272 Greenville Avenue
Dallas, TX 75231-4596

After - American Stroke Association

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