If - American Stroke Association

contents
July/August 2005
Feature Story
Healing through Music 14
“I think I should have no other mortal wants, if I could
always have plenty of music. It seems to infuse strength
into my limbs and ideas into my brain.” — George Eliot
Articles
Determined Kathy 11
Kathy Morelli was an avid bicyclist
before her stroke. With a little help from
her friends, she’s on the road again.
Advances in Rehab 13
Two new, up-and-coming post-stroke therapies.
Stroke. You’re the Cure. 21
Find out what ASA is doing and what
you can do to make a difference.
16
Examining Medicare Reform 23
Plain-English explanations of recent changes.
Cholesterol — New Information
for High-Risk Patients 26
When it comes to “bad” cholesterol, new guidelines
for high-risk patients say “the lower the better.”
Departments
1
Stroke Notes 2
Readers Room 6
Life at the Curb 28
Letters to the Editor
Introducing a new column from
comedian (and survivor) John Kawie.
Everyday Survival
30
23
Stroke Connection Magazine is underwritten
in part by Bristol-Myers Squibb/Sanofi
Pharmaceuticals Partnership, makers of Plavix.
26
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 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
L E T T E R S
editor
to the
Con n e c t i n g Yo u t o Us
My husband had a stroke
at age 59
in May 2002. He experienced short-term memory loss
and has shown improvement. He was unemployed at
the time. We had to use what little savings we had for
prescriptions and to help with living expenses. He is an
only child, both parents deceased, and last February we
had to cash an IRA. He wasn’t thinking, I guess, and the
bank didn’t remind him that this would be income and
now we owe a few thousand dollars in taxes!
He cannot receive disability due to not working at
the time of the stroke. We are fearful of the future —
will we have money for prescriptions, etc.? He has also
been diagnosed with sleep apnea but is unable to wear
the device that helps prevent sleep apnea. He takes one
or two naps daily and believes his medications make
him sleepy. However, his doctor is not too quick to try
anything else.
Thus the reason for this letter: Do your readers have
any suggestions on relieving the sleepiness so he might
feel like doing everyday house errands and help with
our financial difficulties? I am 55 and could retire but
financially I am unable to. Many of the things in Mary
Morgan’s story in March/April issue reminded me of
my husband. She is correct, the medical profession
does not give the patient or family much information.
I believe more should be communicated.
Linda Jennings, Caregiver
Pennsboro, West Virginia
What a great magazine!
I am inspired
all over again. A year after my stroke, I volunteered to
visit some recent survivors. I was discouraged that most
only wanted sympathy, rather than working to recover
some of what they had lost. I wish I had known about
Stroke Connection so I could have added them to the
subscriber list.
Rick Davis, Survivor
Salt Lake City, Utah
I am a hemorrhagic stroke
survivor since December 1999, and at present I am
suffering thalamic pain syndrome. Endurance is my
lifestyle since then. According to my neurologist,
my hypothalamus was pushed by a blood clot during
my stroke, and it is not easily addressed. Through
your magazine I’ve got encouragement that life must
go on though tough! Living in pain (left side from
ear, eyes to toes), spasms, excruciating pain and
lots of it is my daily experience, yet I’ve survived
already more than five years. Your magazine really
inspires me.
Leobardo Felipe, Survivor
General Santos City, Philippines
Editor’s Note: We investigated thalamic pain in our September/
October 2003 issue. That article is now available on our Web
site, www.strokeassociation.org.
My wife had a stroke seven years
ago and has suffered with lack of interest and terrific
headaches all day, every day, since then. Our family
doctor says she may gain some interest back, but it’s
been seven years. She is very frustrated.
As for the terrible headaches, she’s been trying
pain management. If she takes pain pills, they
provide some relief but when they wear off, the
pain becomes 10 times worse.
If anyone has experienced anything similar, did
you find something that helped?
Weldon Power, Caregiver
Steweache, NS, Canada
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.
July/August 2005
1
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Con n e c t i n g Yo u t o t h e Wo r l d
Virtual Reality
Games Spark
Gains
P
laying interactive virtual reality games
significantly improved motor function
in a small study of stroke survivors. The
technology appears to help reorganize brain
functions, allowing survivors to regain some
walking ability.
Stroke often impairs one side of the body and walking
ability. In many cases survivors compensate for the
impaired leg by using the intact leg, which can cause
further problems in the weakened limb.
“There have been a number of approaches used in
stroke rehabilitation to help patients recover gait function,
but outcomes have been variable,” said lead author
Sung H. You, P.T., Ph.D., assistant professor of physical
therapy at Hampton University in Hampton, Va. “The
problem is that we don’t fully understand how recovery
after stroke affects the brain. So we investigated how
virtual reality intervention affects stroke patients’ brains,
and, ultimately, their ability to walk.”
2
July/August 2005
Dr. You studied 10 survivors (average age 57) who
had experienced strokes at least a year earlier. All had
weakness on one side. They were randomly assigned to a
control group, which received no intervention, or a virtual
reality (VR) group, which received the computer-assisted
training an hour a day, five days a week, for a month.
Three games were used — Stepping Up/Down,
Sharkbait and Snowboarding — to build range of motion,
balance, mobility, stepping and ambulation skills.
Stepping Up/Down simulates going up and down
stairs and helps hip flexion and extension, weight-shifting
and balance.
Sharkbait simulates deep-sea diving with sharks,
electric eels and other sea creatures, and requires weightshifting, stepping, protective reflexes and squatting.
Snowboarding simulates snowboarding down a
narrow slope, and requires trunk flexing and extending,
lateral bending and weight-shifting.
In each game, the patient is positioned in front of
an interactive screen which projects a “virtual reality”
scenario.
Researchers measured patients’ ability to walk before
and after therapy, and did imaging studies of the brains of
the five patients who had VR training.
Before therapy, brain imaging showed that
movement in the affected leg stimulated activity on
both sides of the brain, which is abnormal. After
therapy, movement in the affected leg stimulated
activity in the opposite hemisphere.
“These are the first findings that suggest that VR
training results in a reorganization of brain activation,
which is associated with improved gait function,” Dr. You
said. The brain reorganization was associated with
notable gain in locomotor function.
“Most of the VR-trained subjects reported spontaneous
uses and confidence in the affected limb during daily
activities such as transferring in and out of the bathtub,
putting on trousers and stepping onto a step or curb,” Dr.
You said. “These functions were not possible before VR.”
To view a video news release of this story, visit
www.strokeassociation.org.
Freedom to choose where, when and how to explore life is the aspiration
of virtually every American. For many persons with physical disabilities
and special transportation needs, having choices to fit their individual
needs provides a rewarding experience. Ford Mobility Motoring offers
valuable financial and practical assistance, including reimbursement for the
exact amount of vehicle adaptations, up to $1,000 on adaptive equipment
and up to $200 on alerting devices, lumbar support and running boards.*
Ford Credit Mobility Financing — Offering flexible finance terms for
persons with physical disabilities and their families. In addition, they will
finance both the vehicle and the adaptive equipment for qualified customers
enrolled in the Ford Mobility Motoring Program.
Roadside Assistance — Tire changes, towing, fuel delivery, lockout
assistance and jump-starts are now just a phone call away. In times of
need, a 24-hour toll-free number can bring assistance any day of the year.
In memory of Christopher Reeve.
The Christopher Reeve Paralysis Foundation (CRPF) is committed
to funding research that develops treatments and cures for paralysis
caused by spinal cord injury and other central nervous system
disorders. The Foundation also vigorously works to improve the
quality of life for people living with disabilities through its grants
program, Paralysis Resource Center and advocacy efforts.
www.mobilitymotoringprogram.com
1-800-952-2248
1-800-833-0312 TTY
1952 - 2004
*Total reimbursement is not to exceed $1,000. Options available for factory installation are not
considered eligible under the terms of the program.
MA8629/12-04/4
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New
Clot
Buster
Long-Term
Air Pollution
Exposure May
Be Bad for
Arteries
4
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July/August 2005
Con n e c t i n g Yo u t o t h e Wo r l d
D
esmoteplase, a genetically
engineered blood-clot
buster, is showing potential
in the treatment of acute
ischemic stroke. According to studies, the
medication could be effective up to nine
hours after the onset of symptoms.
Current clot-busting treatments must
be administered within a three-hour
window from symptom onset, and most
survivors do not arrive at the hospital in
time for effective treatment.
DIAS2, a multinational study initiated
by Forest Laboratories in February
2005, aims to corroborate the already
promising findings on desmoteplase.
“Preserving brain function and
restoring quality of life in patients after
acute ischemic stroke is the goal of
effective stroke treatment,” said Anthony
Furlan, M.D., medical director of the
Cleveland Clinic Foundation and primary
investigator of the study.
A
study published in the
February 2005 issue of
Environmental Health
Perspectives found that
patients with long-term exposure to air
pollution are more likely to develop
atherosclerosis.
The study is the latest to confirm air
pollution’s role in cardiovascular disease
and the first to link atherosclerosis with
exposure to the fine particulate matter
that makes up air pollution. “We’ve
known for some time that air pollution
leads to lung damage, but this study also
emphasizes the role air pollution plays
on the arteries,” said Dr. Jim Burkhart,
science editor of Environmental Health
Perspectives. “Heart disease is a primary
cause of death in the Western world, so
more research, perhaps focusing on those
at highest risk, is important.”
Possible
Treatment
for Brain
Hemorrhage
A
coagulation factor
called NovoSeven
Recombinant
Activated Factor VII
(rFVIIa) reduced mortality and
hematoma growth, and thus
improved clinical outcomes for
patients with acute intracerebral
brain hemorrhage (ICH),
according to a 2004 study.
Norvo Nordisk Inc.
announced the promising results
at the International Stroke
Conference in New Orleans,
Louisiana, in February 2005. The
coagulant rFVIIa slowed growth
of intracerebral hematomas
when administered within
four hours of symptom onset,
researchers found.
“The current medical and
surgical treatment options for
ICH are not effective,” said
lead author Dr. Stephan Mayer,
associate professor and director
of the Neurological Intensive
Care Unit at Columbia University
Medical Center.
Mayer said that 35 to 50
percent of ICH patients die
within one month, while those
who survive live with serious
neurological problems. He
pointed to the trial results as
reason to hope for a more
effective treatment. “The
current data suggest a possible
change in our paradigm for the
treatment of ICH,” he said.
R
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room
Con n e c t i n g Yo u t o O t h e r s
Sneaking a Thank You
My family was there at every step to help. My sister paid
my bills and the mortgage on my house until I could get set
up on disability. Each person took one or two things to help
me get through.
It’s been almost two years since my stroke, and my
sight is still bad. The doctors think that it’s as good as it is
going to get: It’s double vision in a tunnel. I can’t drive,
but I have friends that will take me where I need to go. I
tried the bus once but got lost. I can’t walk without falling, but I have friends to steady me. I can’t see or remember where I need to go, but I’ve found helping hands at
my door. I can’t remember how to write words that others
will understand, but there are those who will help me say
what I mean. I get depressed but take time to look around
and find that I am blessed.
I know this is not written on good paper with no mistakes, but it is a “thank you” to all my family, friends and
animals and a “hang in there” for those who are working
through the hard path they’re on. I’ll pray for you.
Karmen Coombs, Survivor
Salt Lake City, Utah
Up Life’s Way
I
Karmen Coombs and Timba
am 48 years old, and my stroke affected both
optic nerves, the top of my spinal cord and affected the right side of my face mostly and the
left side of my body.
I have not yet regained the use of the computer
and I no longer spell very well, and as far as what
I write making sense, sometimes it will, sometimes it won’t. I didn’t have my caregivers go
through this letter to make changes. They are the type that
say they need no thanks and would not mail it.
Just before I had my stroke at 46 I trained a beautiful
dog named Timba to be a service dog. At his checkup
before turning him over, they found he had a birth defect
and they could not use him. I was allowed to keep him,
and he has saved my life many times.
I have friends who loved me before the stroke, and they
have helped me in many ways. And they still love me, even
though I have changed in many ways. Stroke changes life in
many ways, forever.
6
July/August 2005
To All the Stroke Survivors and Family —
Greetings of Love, Peace and Joy —
We keep all in our prayers.
One never knows
Life’s twists and turns
Certain woes
As Life’s way
Some up
Some down
You make the best
You grow in knowledge
Then comes wisdom
Look up Look out
Smile
And be thankful
To the Creator
That made us
For His Love and Kindness.
Ruthann H. Fleming • Phoenix, Arizona
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
July/August
2005 Group
7
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).
8
July/August 2005
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
compared with 0.3% for placebo + aspirin.
Adverse events occurring in �2.5% of patients on PLAVIX in the CAPRIE controlled
clinical trial are shown below regardless of relationship to PLAVIX. The median duration of therapy was 20 months, with a maximum of 3 years.
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)
% Incidence (% Discontinuation)
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
% Incidence (% Discontinuation)
Body System
PLAVIX
Placebo
(+ aspirin)*
(+ aspirin)*
Event
[n=6259]
[n=6303]
Body as a Whole- general disorders
Chest Pain
2.7 (<0.1)
2.8 (0.0)
Central & peripheral nervous system disorders
Headache
3.1 (0.1)
3.2 (0.1)
Dizziness
2.4 (0.1)
2.0 (<0.1)
Gastrointestinal system disorders
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.
Brief Summary of Prescribing Information Rev. November 2004
R
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A
D
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S
room
Con n e c t i n g Yo u t o O t h e r s
Emergence
of Light
I
Edward Riaboy
Stroke Changes Things
I was released from the hospital with a stroke
diagnosis on our 50th wedding anniversary. My life
has changed in some respects since that happened
in September 2002.
For instance, I use a cane now. Whenever I walk
with someone, I hold their arm and use my cane.
Except at home, I use a cane everywhere.
I take 11 pills each day to prevent future problems.
I try to walk two miles every day. I walk only in the
daylight now, never at night. At intersections, I turn my
head completely both ways to look for cars. I don’t
drive — the doctor and my wife both say I should not,
so we haven’t bothered the DMV with the problem.
I am not allowed to climb ladders, or fall down.
I am uneasy in crowds because I can only see
people who are in front of me. Church friends are
very good about coming up in front of me before
they speak. Eating out is a problem because I can’t
see the waitress come up behind me and put the
food down or take it away. I’m always afraid I’ll spill
something that I don’t know is there.
Now I hold all of our church shepherd group
meetings at my home, rather than rotate them
through the group each month. This group of 15 has
been together for seven years, and they have been
very supportive of me.
I am now 76 years old, and my vision has not
changed since the stroke. My wife and I have
adapted to it and learn every day how to cope with
it. The Lord has been good, and we are grateful for
every day that we have been given to learn to live
with such a minor handicap.
John Mitchell, Survivor • West Covina, California
survived a hemorrhagic stroke in May 2001. After
my stroke I could not talk or write, and I lost my
memory. My legs were spared, so I could walk.
Initially I was depressed, but over the next several
months, with the help of therapists, friends and
family, I relearned some very basic things, like how to
use utensils and how to sign my name.
I worked with a speech therapist three times a week
for the first six weeks. Progress seemed very slow, but
I was determined to get better. I fought this stroke with
speech therapy sessions every Monday and I worked
hard. My teacher gave me progressively more difficult
homework. In time, it became easier for me.
It’s been three years and I’m still working at my
therapy, and now I can communicate with people. I am
80 years old, a retired optometrist, and I wrote this poem.
It was years ago,
When a sudden
Eruption of hot
Blood in my head.
It was in the night,
When an artery blew
Asunder my nerves
To die.
I could not speak,
I could not write,
I could not communicate
With people.
“Aphasia,”
Said the doctor.
“Therapy,”
Said the doctor.
Many years of therapy,
Working very hard.
I seek for the bright
Emergence of light.
Edward Riaboy, Survivor
Ellicott City, Maryland
July/August 2005
9
R
E
A
D
E
R
S
room
Con n e c t i n g Yo u t o O t h e r s
25 Years of Stroke Survival
T
he average person has
many personalities
that are all interwoven
and blended. Their
expression is
determined by what is held back
and what is not. A stroke separates
all those personalities and displays
all of them in dramatic mood
swings. I have found that all my
moods can come out in as little as
an hour. You feel everything from
anger to depression, bitter to happy
and content, and the cycle just
keeps repeating.
You don’t want to get stuck in a
bad mood because you will just have
a tougher time and just have to live
through it. That is when you should
get help. And remember, you move
along at a frustrating snail’s pace.
There are two attitudes that
occur after a stroke, if you want to
continue living.
First, because of the losses, you
are a different person. You must start
over or die.
Second, hang onto everything that
still works. Retain a positive attitude
and let the rest go. You must let go of
your past life as if it died.
If you can improve anything
to above average, it will give you
a sense of accomplishment and a
reason to live. Now, there must be
something you can work on or you
would be in a coma. Get busy.
Joe Zwijack, Survivor
Mokena, Illinois
Joe Zwijack
Have you or someone you know
suffered a stroke?
Select stroke centers nationwide are seeking
individuals who have suffered a stroke
(even if your stroke was many months or
years ago) that has caused weakness in
one hand and/or arm to participate in an
investigational research study.
Purpose: The study will assess the safety and
effectiveness of an implanted device* in treating patients
who have reduced hand and/or arm function after stroke.
Participation Criteria: Patients at least 21 years of age
who have suffered a stroke, which has caused weakness
in one hand and/or arm, may be eligible for this study.
Study Sponsor: Northstar Neuroscience, Seattle WA.
www.northstarneuro.com
All costs related to the study and rehabilitation (including local transportation) will be covered for those who qualify.
Please call today for more information: 888-546-9779 (24 hr. support)
*Caution: Investigational device. Limited by Federal (or United States) law to investigational use.
10
July/August 2005
Determined Kathy
by Jon Caswell
T
here’s a reason people call Kathy Morelli
“Determined Kathy.”
“Life is tough,” says the 47-year-old
survivor from Battle Ground, Washington.
“I’m tougher.” In the last five years she’s had plenty
of opportunities to prove it.
First, there was the stroke. “High blood pressure
coupled with birth control pills threw a blood clot,” she
said. “A big chunk of the right side of my brain is gone.”
And with that chunk went her speech and her left side.
Then there were the six stroke-related surgeries, and
Kathy and her customized trike
the fact that she and her husband David had just bought
a two-story house a month before her stroke. “Dave added a right-hand railing on the stairs —
works for me. I came home in a wheelchair but it didn’t take long for me to relearn to walk.”
Before her stroke, Kathy had been an avid cyclist. A member of the Vancouver Bike Club (VBC) in
Canada for several years, she had ridden the 200-mile Seattle-to-Portland race five times. But the stroke
ended that — at least for now.
Her speech finally came back, but her left side did not. So with the money she got from selling her
car — “It didn’t have power steering” — she bought a specialized stationary bike and began riding
it an hour a day.
Word that Determined Kathy was spinning the pedals again reached the members of VBC, where she had
been vice president and chaired several riding events. In the hope that they would some day ride with her
again, they raised money and “bought me a gorgeous, red recumbent trike that is customized for my needs.”
Using her old bike shoes, she pedaled around the neighborhood for several miles. “It was awesome, the
wind in my face again and that wonderful exertion. The VBC is the best bunch of pals ever. I can’t wait to
ride with them again. I hope to try the Seattle-to-Portland ride one more time.”
The Voice of Experience
Before we heard about her trike story, Kathy introduced herself in a series of
pithy e-mails signed “Determined Kathy.” They had the ring of truth to them,
the voice of experience. Here is a sampler:
Subject: No Feeding Tube
>> Tried to swallow and choked. They said this was common as the muscles in the throat
are paralyzed, too. I couldn’t eat or drink and the doctor said, “We have to put a feeding tube
in her.” Dave said, “Like hell you will.” He and my mom got some applesauce and gradually
fed me. All my drinks, including water, were thickened like paste to prevent choking. The
therapist showed me how to tuck my chin in order to force a swallow and advised me the
more notable the temperature of the beverage, i.e., very hot or very cold, the better your
throat recognizes it and remembers to swallow. I went through a few coughing fits and lots
of mushed pancakes, but no feeding tube.
>>continued on page 12
July/August 2005
11
Subject: Peeing,
Rebirth & Velcro
>> After running water, soaking my fingers
in warm water and concentrating very hard,
I learned to pee again. I still struggle with
that four years later. I no longer get physically
aroused either, that part of the brain is dead,
too. A stroke impacts more than just the
obvious, it’s like a rebirth of sorts. Everything
you knew has to be relearned, unless you need
two hands to do it — thank heavens for Velcro.
Subject: The Good
Go to Heaven
>> I was in a nursing home and then a
rehab center for a while. Because of the
stroke my knee hyper-extends and my foot
drops and the ankle twists. My therapist
wrapped my foot, pulling the toes up so I
wouldn’t trip, and had me shuffle down the
hall. I was hanging onto the railings for dear
life — a death grip. I was scared, and this
from a woman that has jumped out of an
airplane! Then I went to a rehab center. They
fitted me for a brace and gave me a cane —
first a sturdy four-prong, then a wimpy
single prong.
The day I left there, the therapist took me to
the emergency stairs and said, “OK, Kathy,
we’re gonna learn stairs now.” I gulped and
she said, “Remember this: the good go to
heaven, meaning your good foot goes up first.
The bad go to hell, meaning your weak leg
goes down first.” That’s how I learned steps
before I moved back into our two-story house.
Subject: A Tornado
through the Brain
>> Everyone was surprised I felt things in my
paralyzed hand, then I realized they thought
I have no feeling on the side affected by my
stroke. It’s paralyzed from movement but I
still have feeling there; in fact, sometimes
pain. A stroke is like a tornado through the
message center of your brain. It’s a major
communication breakdown between brain and
body, for some even breathing is lost. For me it
was movement, swallowing, peeing and short
term memory that were most affected.
12
July/August 2005
Advances
in Rehab
Restoring Vision
NovaVision VRT™ (vision restoration therapy) is a computerbased, FDA-cleared vision-enhancement program for stroke
survivors. The therapy is customized for each patient and does not
require surgery or medication.
After a stroke, the brain neurons that process visual images are
sometimes damaged and the ability to process visual information
can be lost. NovaVision VRT helps restore vision by stimulating a
process called neuroplasticity in which brain neurons adjust their
activity to compensate for injury.
Before therapy, patients undergo a diagnostic session to map
their vision loss. The map is used to customize a treatment plan
to increase residual vision. Therapy takes place at home on the
patient’s computer. Changes are monitored monthly and treatment
is modified accordingly. According to Novavision, Inc., 65 percent
of those completing VRT showed measurable improvements.
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Above: a patient demonstrating vision
restoration therapy on his home
computer
Left: a patient’s vision maps before
and after vision restoration therapy
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BIONS (Bionic Neurons)
BIONs (BIOnic Neurons) are the marriage of tissue
and technology. These glass-encased electrical
stimulators, each about the size of a grain of rice, are
injected into paralyzed muscles. The glass capsule
contains an antenna coil and a miniature circuit
board and integrated chip, and has two stimulating
electrodes sealed into each end. Once in place,
they receive power and command signals by radio
transmission from outside the body. The external
components include the transmission coil to be worn
over the body part to be stimulated and a device that
stores up to three different stimulation programs.
BIONs, an adaptation of microchips used
for tagging pets, are in the beginning stages of
development. Current applications (in only a handful
of patients in Canada and Italy) are designed to
stimulate small movements to prevent muscle
wasting in paralyzed limbs, and involve only
two devices per muscle. To facilitate complex
movements like walking or lifting, which is the
ultimate goal of this new technology, many more
BIONs would be necessary.
July/August 2005
13
F E A T U R E
g
n
i
l
a
He ough
thr c
i
s
Mu
ll
Caswe
n
o
J
by
14
July/August 2005
usic touches
special places in almost
everyone — from the church
music we heard as children
to the rock ‘n’ roll we danced
to as teenagers. For these
survivors, music has taken on
a healing role, a way to get
beyond their deficits and find
joy where once there was only
despair. Whether they’ve
played before or are
learning anew,
music has helped
them make
connections
in their brains
and in their
communities.
H E A L I N G
T H R O U G H
M U S I C
Jazzing Up Life
for Others
Music is life for John Hopkins.
A jazz pianist, the former Army sergeant-first class has
played for presidents and generals around the world, first as
a member of the U.S. Army band system. After his military
experience, he performed at musical venues throughout
Europe and Asia. His performances came to a sudden and
permanent end in October 1999.
As he was about to go onstage at the famous Grill Room
of the Grand Hyatt Hotel in Tokyo, John had an embolic
stroke that left him in a coma for 10 days. He was 46 years
old. Doctors gave him 48 hours to live, and his sons, both in
the military, flew in to be by his side.
“While I was in the coma,” John said, “my father, who
had died of Alzheimer’s several years before, came to me.
He said, ‘If you are ready to go, I will take you, but God
has something else for you to do. He’s not ready for you to
leave yet.’ I told him that I wasn’t ready to go, and at that
moment I sat up in bed. For the first time in weeks I had a
conversation that could be understood and made sense.”
John was in the Tokyo hospital for three months, but
because he didn’t have insurance, he didn’t receive any
therapy. Paralyzed on his right side, he also lost his speech,
or at least part of it. Then,
“When I see the on Christmas day 1999, with
help from some
courage and financial
friends, John flew out of
confidence my Tokyo, lying down and still
students have attached to medical equipment.
He arrived at his son’s home
developed, then
in Washington State, where
I know we have he began therapy at a local
achieved success.” hospital. That was interrupted
when he went to Russia to be
with his life partner who was working in Moscow at that
time. “When I went to Russia, I was in a wheelchair,” John
said. “They worked with me there, and when I came back
to the U.S. two months later, I was walking.”
He settled in Leavenworth, Kansas, to be near his son
and a VA hospital. He could walk, but he still couldn’t use
his right hand, and he knew his professional playing days
were over. Restless and ready to be purposeful again, John
began looking for another way to share his music with the
John Hopkins working with an Age & Play client
world. “So many friends and family members had helped
me, I wanted to give something back.”
Out of this commitment, and in honor of his father, John
contacted a local aging center. “My idea was to teach music
to seniors, to stimulate the minds, bodies and spirits of
people with mental and physical handicaps,” he said. Out
of those visits, John has developed Age & Play, a nonprofit
organization dedicated to teaching music to seniors.
In the three years since John started teaching, he has
shared music with many handicapped seniors. Lessons last
about 30 minutes, but are shorter for Alzheimer’s patients.
At one of the nursing homes, nurses told John of a
woman who had not spoken for 15 years but who had taken
piano lessons when she was younger. When he sat her down
at the piano, she played beautifully, much to everyone’s
surprise. “She’s still playing regularly,” said John.
John now teaches at three locations in Leavenworth,
and the program has expanded to Kansas City, Kansas,
and Colorado Springs, Colorado, where Age & Play board
member Don Wagler handles the teaching duties. “We have
recitals for our students so they can play for family and
friends,” said John. “It gives them something to aim for.”
It gives something special to John, too. “When I see the
courage and confidence my students have developed, when
they perform before an audience of strangers or when my
physically challenged students can memorize the terms that
are meant to strengthen their minds, then I know we have
achieved success. This is God’s way of saying to me, ‘Well
done,’ and what more does one need?”
July/August 2005
15
H E A L I N G
T H R O U G H
M U S I C
Surviving to Sing
A
s a carpenter, Trevor Gibbons knew to step
into a building through a door — not a
window. But as he was framing windows on
the 4th floor of a building in New York City, he
suddenly got confused, his vision blurred, and
he stepped out of a window into thin air.
A stroke can do that to you.
When he was found three hours later, Trevor was
rushed to a hospital. A CT scan confirmed a clot,
and he received treatment then was moved to rehab.
“After a month there, I was still getting pain in my
shoulder,” Trevor said in an interview at Beth Abraham
Rehabilitation Center in New York. “I thought it was
from the stroke, but when they did an MRI of my spine,
they found herniation of the cervical spine.”
Doctors performed surgery, but the clot-preventing
drug warfarin was not started soon enough, and he had
another stroke.
“I couldn’t speak, and I was in a harness for 14
months. That’s when I came to ‘Beth Abe,’ September
2001,” he said. “I was flat on my back for 10 months,
counting dots on the ceiling. I was very depressed.”
“During my recovery,
my key words were
endurance, strength
and courage, and
they have brought
me this far.”
That’s when he met music therapist Lucy Butler, an
intern at the time. “She would bring her piano to my bed
and encourage me to sing ‘This Little Light of Mine.’
My vocal cords were damaged, but I began to try. Her
motivational skills helped me overcome so many things. I
have a limp on my right side, but I can walk now.
I have upper-body motion. My hands are open. I can write.”
And he can sing “This Little Light of Mine.” In fact,
through music therapy, Trevor found that he could not
only sing songs, he could write them. “One day Lucy
encouraged me to write my own feelings,” he said. “At
the time, I was looking out the window, and that became
the first line of my first song.” Then he sings in a clear,
strong baritone:
16
July/August 2005
Trevor Gibbons performing at the Lincoln Center
“Sitting at the window, watching the cars go by,
wondering why I’m feeling so empty inside. Don’t know
why my days are so short and my nights are so long, but I
know one day I’ll go home again.”
Although he has no formal musical training, writing
and singing became the focus of Trevor’s life. “I wrote
three more songs,” he said. “By the time I was able to
sing, the harness was off me.”
He met the well-known recording artist and music
producer Moby when he made a visit to Beth Abraham.
The entertainer donated money for a recording studio at
the rehab hospital.
Within a few months, Trevor had recorded a CD with
10 original songs. Then last fall he was asked to perform
at the Music Has Power awards at Lincoln Center. “After
I came home that night — I’m in a long-term care unit
at ‘Beth Abe’ — I wrote another song and went into the
studio the next morning and recorded it. It’s called ‘One
Thing Sure.’”
Trevor’s first CD, “Trevor’s Melodies,” was released
in spring 2004, but it was only the beginning. “During
my recovery, my key words were endurance, strength and
courage, and they have brought me this far. I keep writing
songs, and they have to do with my life. I already have
10 more songs. Music is my inspiration, my escape from
sadness and loneliness and pain. When I start to sing, it
opens up my mind and I think, ‘There’s nothing I can’t do.’”
H E A L I N G
L
T H R O U G H
Spreading
Healing
Vibrations
ynn Marks never thought about playing the harp
till she had a stroke in 1997. In fact, she had
never played any musical instrument, nor could
she read music.
The stroke was the result of an arteriovenous
malformation in her left temporal lobe that left
her with aphasia and anomia. Lynn, who was 42, also had
significant right-side weakness, couldn’t even use her right
hand for such simple tasks as washing her face, and walked
with a cane.
“I went several months where I couldn’t communicate
easily because I had lost my nouns,” she said. “I would
cry and scream in frustration because I could understand
everything that was
“I knew from the going on — no
beginning that I survived memory problems,
intellect intact. The
the stroke because I had frustration level was
a mission. When you tremendous because
get a second chance, I I was locked inside
my head with all these
believe you have an monologues going on.”
obligation to give back.”
During this time
she saw a television
documentary called “Healing Harps.” It was an account
of how Dr. Ron Price, a professor of music, was teaching
multiple sclerosis (MS) patients to play the harp to increase
their motor skills. Some were even kept out of wheelchairs.
“The harp has a vibratory impact,” Lynn said, “and he
believed that was what helped the MS patients. I felt like
that might help stimulate my brain, since music is stored in
the right side. It was hard to find ways to stimulate my brain
because I couldn’t read, since words are stored in the left
side. Reading is still very labor-intensive for me. If I read
even a page, I have to sleep for hours.”
It took another year for Lynn to regain enough strength
to start taking harp lessons. “It’s been wonderful because
it’s a difficult instrument. You have to read the music, pluck
the strings and change the key with the pedals, so I must
M U S I C
use my arms and legs
at the same time. About
a year after I started, I
noticed one morning that
I was using both hands to
wash my face, so playing
the harp had worked. My
internist can’t believe
how much it’s benefited
me,” she said.
The benefits of Lynn’s
playing opened up a new
life with special meaning.
“I knew from the
beginning that I survived
the stroke because I had a
mission. When you get a
second chance, I believe
you have an obligation to Lynn Marks making good vibrations
give back. It has to be about giving back to others or your life
isn’t going to have any purpose.”
A friend from church asked Lynn to play the harp for an
elderly choir member who was near death. “When I asked the
woman if she wanted me to play, she smiled. I played for her
for eight hours. As I said goodbye, she smiled and tears ran
down her face. She died a few hours later. I told my husband
Peter that this was what I was here for.”
Once the word got out, Lynn got many requests to play
for people making their final transition. Generally she takes
her harp to the patient’s home and plays every day until the
person passes away.
“I work with them until the end. It’s usually a week or
two. That gives me very intimate time with the people and
their families.
“The longer I work with them the more fulfilling it is,”
said Lynn. “It’s nice to get to know them. One patient would
direct me. Another would sing with me, even though he
couldn’t carry a tune in a bucket.”
Lynn also plays twice a month at a 14-bed hospice and
once a month at a nursing home. At the hospice, Lynn goes
to each room and plays for the patients individually. “It’s
fabulous because you can see what it does for them. It can
reduce their heart rate and blood pressure and increase
oxygenation, so their pain levels decrease. It gives them a lot
of pleasure, and it brings peace to the whole room.
“Playing at the nursing home is rewarding because the
residents each have their individual personalities, and they
are a hoot. Every activity is a big deal to them because their
days are so small. It’s fun.
“But my real passion is playing for people who are dying
and helping them to make that transition.”
July/August 2005
17
H E A L I N G
T H R O U G H
M U S I C
In Tune with One-Handed Jazz
Kay Breslin had always had music in her life.
She had been studying jazz with piano
teacher Mark Miller for several years, when an
arteriovenous malformation ruptured in August
1998 and paralyzed her left side. “After a lot of
prayer and therapy, I got back on my feet,” she said
from her home in Barrington, Illinois. But her left
hand didn’t come back, and she gave up the piano
because there’s not much music for one-handed
piano players.
“Despite the urging of friends and family to get
back to music, I wouldn’t even give it a try,” she
said. Then a friend called Mark and commissioned
him to make a musical arrangement for one hand
as a birthday present for Kay. Intrigued by the gift,
she started to practice.
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18
July/August 2005
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H E A L I N G
T H R O U G H
“It took about a week for me to master that
piece,” said Kay. “When I saw that I was able to
do it, I had Mark start coming to the house every
week. I spend two hours a day practicing the
pieces he brings. I’ve probably learned 20 to 25
pieces. Each arrangement seemed to get a little
more difficult, so I was always being challenged.
I’m always working on something new.”
M U S I C
arrangements. “And 95 percent of those that are
available are for classical pieces and are written
for the left hand only, so they wouldn’t have been
much good to Kay,” said Mark. “Writing for one
hand necessitates putting both harmony and
melody within the reach of just one hand, which
is about eight keys.”
Mark has worked with several stroke survivors
like Kay. Although he goes to her house, he also
gives lessons over the phone. And on a recent
visit to Scottsdale, Arizona, Kay took her lessons
long distance. “It was great,” she said, “because
I got to continue my progress.”
Although Kay was a musician before her stroke,
Mark is certain that a survivor without prior
musical training could learn to play with one
hand. “I write the arrangement to match the skill
level of the individual student,” said Mark. “If they
have a phone and a keyboard, they can learn to
play jazz piano.”
Mark enjoys teaching people to play with one
hand, but he notes that there aren’t many
For more information, contact Mark at
[email protected] or 1-800-327-4266.
Please send to:
American Stroke Association
Planned Giving Department
7272 Greenville Avenue
Dallas, TX 75231-4596
c
c
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 Heart 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
americanheart.org/plannedgiving or e-mail us at
[email protected].
c
c
Please 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)
Name
Address
City
State
ZIP
Phone
Birthdate
E-mail
IAD SC 07/05
06APGAA
KC-0154
July/August 2005
19
H E A L I N G
T H R O U G H
M U S I C
What is Music Therapy?
and gait as well as
improving speech,
memory function,
attention and focus.
“The end result of
music therapy is not
necessarily to play
music but to enhance
mental function,
speech production
and breathing,” she
said recently. “Music
therapy helps patients
who can’t control their
muscles to organize
motor movement.
“When people
are spontaneously
involved in an activity,
they may move in
ways they couldn’t if
Dr. Connie Tomaino
they thought about
revor Gibbons (“Surviving it. That’s because in a lot of head
injuries, there’s damage to what is
to Sing,” p. 16) benefited
from the specific intervention called executive function, which is
the ability to plan out and perform
of a music therapist. History
a task. Although there may be
is on his side.
functionality that allows the muscle
Interest in the therapeutic value
to move, the person may be more
of music goes back about 2,400
likely to move it if we can stimulate
years to Plato and Aristotle, but
the muscle through a different
the modern professional discipline
network.
began only after WW II. Today
“When a person is encouraged
music therapy is used in a wide
to use their affected side, say with
range of rehab settings.
a keyboard,” said Dr. Tomaino,
Dr. Connie Tomaino, who is both
“they have to acknowledge that
a doctor of music therapy and a
limb exists. Calling attention to
board-certified music therapist
that neglected side increases the
(MT-BC), is vice president of music
chance that they will move that
therapy at Beth Abraham Family
side at will.”
of Health Services in New York
Survivors who can’t talk may
City. She explained that music
be able to sing, as was the case
therapy can be part of rehab from
with Trevor, who also regained his
assessment through treatment.
speech. “These abilities — whether
Music therapy has proven
speech or rhythmic movement
effective in improving balance
20
July/August 2005
— are stored in people. The trick is
how to get those networks lit up.
“Singing and speech use a
parallel mechanism, so skills used
to sing words may carry over
to regular speech. Songs with
predictable lyrics, popular songs
and songs from childhood may be
easier for survivors to sing than
unfamiliar music.”
Many patients with brain injuries
lack the attention span to perform
a series of steps. But when music
is added, often they can focus
long enough to accomplish the
movement. “Following is less
difficult than initiating, so they can
accomplish the same physical
goals without having to instruct
themselves how to do them,” Dr.
Tomaino said.
Music, whether playing, singing,
listening or writing, is always
involved in a music therapy session.
The goal is to involve the patient
in responding. “We use a wide
range of instruments. We use a lot
of digital instruments because you
can adjust the output. For instance,
turning up the volume on digital
drums allows someone who is weak
to hear the effect, which can be
very motivating.”
Insurance reimbursement for music
therapy varies from state to state.
Accredited music therapists
must earn a college degree in
music therapy and pass a national
certification exam. They carry
the MT-BC credential. For help
in locating a music therapist,
contact the American Music
Therapy Association at 301589-3300 or send an e-mail to
fi[email protected].
Lobbyist.
The AHA/ASA have worked to
convince the National Institutes of Health
to increase stroke research funding, and
are currently lobbying on behalf of the
STOP Stroke Act, which would increase
public awareness of stroke and promote
improved treatment measures.
Over the years, the AHA/ASA have
achieved numerous health policy
victories. In large part, these victories
are due to dedicated volunteers
and advocates across the country.
These supporters are not lobbyists by
profession, however, they are survivors
and caregivers, healthcare professionals,
as well as everyday people who realize
that small actions can make a huge
difference in the fight to save lives.
AHA/ASA network advocates have
sent over 30,000 e-mails and have placed
nearly 3,000 calls to lawmakers during
the past year alone. This April, over 500
of them participated in AHA’s annual
Lobby Day in Washington, D.C. The
You’re the Cure network aims to increase
participation and instill greater passion
“We hope that by acting,
networkers will feel that they
have achieved something
meaningful for themselves
and their families.”
Stroke. You’re the Cure.
American Heart Association and American
Stroke Association are passionate about
stopping heart disease and stroke, and they
want others to share that passion. That’s why they recently
launched Heart Disease and Stroke. You’re the Cure, a
campaign to motivate volunteers to take action on important
legislative issues.
Along with the new look and feel for the association’s advocacy
efforts, the AHA/ASA has also developed a more effective
approach to communicate its advocacy messages by evoking
passion through its new grassroots You’re the Cure network.
“The new advocacy theme denotes action and makes
individuals feel that by being an advocate for the AHA/ASA they
are a part of the solution to the problems of heart disease and
stroke,” said Katherine Krause, AHA’s executive vice president
of advocacy. “We hope that by acting, networkers will feel that
they have achieved something meaningful for themselves and
their families.”
in AHA/ASA’s efforts to support public
health policies that fight heart disease
and stroke.
As a stroke survivor, caregiver or family
member, you have first-hand experience
of the devastating effects cardiovascular
disease can have. Therefore, we need
you to lend your voice to important stroke
issues. With just a quick phone call or
e-mail to your legislators, you can inform
them how the disease has affected you
personally and why it’s essential to pass
the STOP Stroke Act. Your voice and
those of other stroke survivors can and
will be heard.
Taking part in this new initiative will
provide additional meaning to you and
your family, as well as the American
Stoke Association. Please detach the
sign-up form on the next page or visit
www.americanheart.org/yourethecure
and join today!
July/August 2005
21
22
July/August 2005
Examining
Medicare
Reform
by Mike Mills
y now, you probably
have heard a lot about
Medicare reform
— the Medicare
Prescription Drug
Improvement and
Modernization Act of 2003. Digesting
the facts of the entire program would
be like binging on a large meal, but
breaking down the new provisions
into small nuggets makes the
information more palatable.
If you have Medicare, or plan to
apply for it when you reach age 65,
this information will help you make
good healthcare decisions. Remember
that Medicare Part A, which helps
cover hospital stays, skilled nursing
care, home health care and hospice
care, requires no monthly premium
for most people who paid Medicare
taxes while working. Part B, which
helps cover doctor bills, outpatient
care and some expenses not covered
in Part A, requires a monthly
premium in 2005 of $78.20 and an
annual deductible of $110, up from
$100 for the past 14 years.
These parts make up the standard
Medicare plan, called the Original
Medicare Plan. This fee-for-service
plan in which most Medicare
recipients are enrolled usually pays 80
percent of an approved amount, after
the deductible, for most services.
Changes mentioned here fall into
three categories: prescription drug
plans, preventive benefits and health
plan choices.
The prescription drug plans,
perhaps the most talked-about
change in the law, are either the
best innovation since sliced bread
or the worst thing that could happen
to Medicare, depending on who is
talking. But we will stick to basics
here and leave the debate to the
politicians and analysts.
Prescription Drug Plans
This Medicare Part D program starts in 2006 and is
entirely voluntary (see chart on page 24):
1. A prescription drug plan requires a monthly premium
of about $35. The actual premium can vary by plan
and geographic area.
2. After paying the first $250 for medicine in a calendar
year, you pay 25 percent up to $2,250.
3. This is where the “doughnut hole” deductible
begins — you pay 100 percent of your prescriptions
until the total reaches $5,100. At this point, you
will have paid $3,600 out-of-pocket (plus the $35
monthly premium).
4. For expenses beyond $5,100, you pay about 5 percent
and Medicare picks up the rest.
5. Low-income people will get extra help to pay their
drug bills. Multiple levels of low-income assistance
exist. In one example, seniors with incomes below
$12,123 in annual income for an individual or
$16,362 for a couple and with assets under $6,000
for an individual or $9,000 for a couple (not
including the value of a home or car) will be able to
buy drugs for $1 to $2 for generic prescriptions and
for $3 to $5 for brand names.
July/August 2005
23
Part D Prescription Plan At-A-Glance
If your drug costs are:
You pay:
Up to:
Total out-of-pocket amount:
$0 to $250
100%
$250
$250
$250 to $2,250
25%
$500
$750
$2,250 to $5,100
100%
$2,850
$3,600
5%
No Limit
$3,600 plus 5% of
costs above $5,100
Over $5,100
2. People at risk for diabetes can be screened for that
disease. Free screenings include a fasting blood
glucose test.
A number of prescription drug plans — all through
private companies — are available under Part D. The
specific drugs that the plans cover, the costs of the drugs,
and the monthly premiums may vary, but the other
guidelines listed above apply to all of the plans. The first
enrollment period will be Nov. 15, 2005, through May
15, 2006, and enrollment will be repeated each year
thereafter during the same months. Your prescription
drug plan will begin the following January 1. However,
you might pay a higher premium if you don’t join during
the first year of eligibility.
Medicare-approved discount drug cards are available
temporarily to help you save 10 to 25 percent on
prescription medicines until the permanent plans
start January 1. Companies can charge an enrollment
fee up to $30 for the discount cards, and it’s best to
comparison shop.
To compare plans select “Prescription Drug and Other
Assistance Programs” at www.medicare.gov or call 1800 MEDICARE (1-800-633-4227). You will be asked
to provide your ZIP code, the names of your medicines
and the dosages, and your total monthly income, in case
you qualify for further discounts. You can enroll before
Dec. 31, 2005, and a further discount is available based
on income, but the cards phase out May 15, 2006, after
the new drug plans start in January 2006.
The coverage that Medicare started this year for
blood tests for early detection of cardiovascular diseases
should encourage people who would not pay for the
screening themselves to take that step. Included in the
screening is a check of total blood cholesterol, lipids and
triglycerides. The screening is available every five years.
A fasting glucose test is available for those who are
considered at risk for diabetes. If you are eligible, check
with your doctor about how often the diabetes screening
is allowed.
Another ally in the fight against cardiovascular
diseases is the one-time “Welcome to Medicare”
physical. Included are height, weight and blood pressure
measurements, plus an EKG and a vision test.
These screenings have been added to preventive
services that are already part of Medicare, including
cancer screenings, bone-mass measurements and some
shots (flu, pneumonia and hepatitis B).
Preventive Benefits
Medicare Advantage
These screenings have been added to what Medicare
already covers under Part B:
Medicare Advantage replaces an older program
with fewer choices called Medicare+Choice. Medicare
Advantage plans provide more health coverage and
better benefits. If you join one of the plans, you are still
in the Medicare system and still receive all the services
1. Checking cholesterol and triglyceride levels to
screen for cardiovascular diseases started Jan. 1,
2005. The tests are free.
24
July/August 2005
3. A “Welcome to Medicare” physical exam is
allowed during the first six months after enrolling
in Medicare Part B. After Medicare enrollees
pay the annual Part B deductible, their cost is 20
percent of the Medicare-approved amount.
that Medicare covers. Advantage consists of four plans:
managed care, preferred provider organizations (PPOs),
private fee-for-service and specialty.
1. Managed care plans require you to see doctors in
a network. You may need to choose a primary care
doctor and get a referral to see a specialist. Copayments usually are lower than those under the
Original Medicare Plan.
2. Preferred provider organization plans (PPOs) allow
you to see any doctor without referral, but seeing
doctors in the network costs less. In 2006, regional
PPOs will limit the out-of-network amount that
members pay.
3. A private fee-for-service plan allows you to see any
doctor that accepts the plan’s payment.
4. Specialty plans provide more focused care for
certain people.
The Advantage Plans are all part of Medicare, and
anyone who already has Medicare Part A and Part B
can choose any of them. A plan may require you to pay
an extra premium for the extra benefits you receive,
or it may pay part or all of your Part B premium. The
specialty plans, designed to treat people with special
medical conditions, may not be available
everywhere.
No one is required to use any plan
other than the Original Medicare Plan.
You will stay in the Original Plan unless
you join an Advantage Plan. Medicare
enrollees continue to use their red, white
and blue cards.
What Is Not Covered
Medicare coverage seems so comprehensive that it
may be helpful to point out a few of the areas that lack
coverage under the Original Plan. Of course, additional
benefits from the Advantage Plans may cover some of
these expenses.
Not covered by Parts A and B in the Original Plan:
Acupuncture
Custodial care (help with bathing, dressing, eating,
using the bathroom) in the home or in a nursing home
Deductibles, coinsurance and co-payments
Dental care, dentures
Hearing aids and hearing screenings
Long-term care (such as custodial care)
Routine or annual physical examinations
Routine eye care and most eyeglasses
Routine foot care
Screening and lab tests (except those listed on pages
26-28 of “Medicare and You 2005”)
Shots and vaccinations (except those listed under
Preventive Benefits)
Some diabetic supplies
Therapy Caps Moratorium
In 1997, Congress placed a $1,500
cap on benefits for outpatient physical
and speech therapy, and a $1,500 cap on
occupational therapy benefits. Congress
has blocked their enforcement ever since
1998. The current two-year moratorium
expires at the end of this year and would
force some seniors and people with disabilities to pay
out-of-pocket expenses for therapy or alter the course of
their care by changing providers or facilities.
Congress is working on a bill now to get rid of the
caps for good. “We are confident that Congress will do
what is right and do away with this burden for Medicare
beneficiaries once and for all by passing this legislation,”
Ben F. Massey Jr., president of the American Physical
Therapy Association, said recently.
Find Out More
The www.medicare.gov Web site provides excellent
information about what Medicare covers. To see answers
to questions you may have, try the link “Frequently Asked
Questions.” Going to www.medicare.gov/publications/
pubs/pdf/10050.pdf will start a download of “Medicare
and You 2005,” the official government handbook on
Medicare. It’s well organized and easy to read. Or call
1-800 MEDICARE (633-2273) to ask questions.
July/August 2005
25
Cholesterol:
New Information for High-Risk Patients
by Jon Caswell
“The lower the better for high-risk people — that’s the
message on bad (LDL) cholesterol from recent clinical
trials,” said Scott Grundy, M.D., Ph.D.
Dr. Grundy, director of the Center for Human Nutrition
at the University of Texas Southwestern Medical Center in
Dallas, was commenting on guidelines from the National
Cholesterol Education Program (NCEP) that were updated
earlier this year. The guidelines now urge more intensive
cholesterol treatment for people at high risk for stroke, heart
attack and death from cardiovascular disease.
September is National Cholesterol Awareness Month.
High cholesterol is a major risk factor for cardiovascular
disease.
After examining five major clinical trials involving
cholesterol-lowering medications, the panel concluded
that people at high risk could benefit from even lower
LDL numbers, below 70 mg/dL. This means that high-risk
patients may still be considered for cholesterol-lowering
drug therapy, even if their cholesterol is below 100. (For
definitions of high and very high risk, see “What Is High
Risk” on p. 27.)
26
July/August 2005
Two Sources
In a recent survey, 77 percent of the respondents
(representing more than 1,000 patients reported as having
high cholesterol) stated incorrectly that the food they
eat contributes the most to high cholesterol. In fact, the
cholesterol in the bloodstream is not just absorbed from
food; the majority is produced naturally in the body.
“The fact is that both diet and heredity play a critical
role in your cholesterol levels,” said Dr. David Cohen,
director of hepatology at Brigham and Women’s Hospital
in Boston. “While diet can contribute significantly to
elevated cholesterol, the body’s natural chemistry can
often produce dangerously high levels of LDL cholesterol
based on heredity alone. When working with a physician
to manage your condition, it is important to understand
that there are two sources of cholesterol and in many
cases both need to be addressed.”
Because cholesterol is used in all the body’s cells, it
travels through the bloodstream. But cholesterol and
other fats cannot dissolve in the blood and must travel to
and from the cells via special carriers called lipoproteins.
These are the famous “siblings” HDL (high-density
lipoprotein) and LDL (low-density lipoprotein).
Since there are two sources of cholesterol, there are at
least two ways of treating hypercholesterolemia — or too
much cholesterol.
“Beyond lifestyle considerations, there are many effective
treatment options available for control of high cholesterol,”
said Dr. Cohen. “I always counsel patients to discuss
treatment options with their doctor. Patients with high
cholesterol should make an extra effort to be as informed
about their cholesterol levels as possible. Knowing about the
sources of cholesterol is a key step in this process.”
A cholesterol-lowering plan should include lifestyle steps
as well as drug therapies to lower risk, members of the Adult
Treatment Panel of NCEP said.
Maintaining a heart-healthy lifestyle is important. “The
idea that you can use cholesterol-lowering drugs without
lifestyle changes is incorrect,” said Dr. Grundy. “Lifestyle
changes have enormous benefits beyond lowering
LDL cholesterol, such as raising good cholesterol,
lowering triglycerides, improving diabetes and reducing
inflammation.”
What is High Risk?
In the NCEP study, the high-risk category includes
people who have
• A history of heart attack
• Carotid artery disease, a transient ischemic
attack (TIA) or an ischemic stroke
• Unstable angina
• Previous coronary artery procedures, such
as angioplasty or bypass surgery
• Peripheral artery disease
• Abdominal aortic aneurysm
• Diabetes
Those who have two or more risk factors (smoking,
uncontrolled hypertension, diabetes, obesity) with
a greater than 20 percent risk of heart attack
or death in the next 10 years are also
considered to be at high risk.
The recommendations call for those at high
risk, to reduce their LDL numbers below 100
mg/dL (milligrams per deciliter).
What is Very High Risk?
Patients are considered at very
high risk if they already have
cardiovascular disease plus
• Diabetes
• Persistent cigarette smoking
• Poorly controlled hypertension
• Multiple risk factors of the metabolic
syndrome (high triglycerides, low
levels of “good” HDL cholesterol,
obesity)
• Individuals are also at high risk
immediately after a heart attack.
For those who are at very high risk, the
recommendations call for reducing their
LDL numbers below 70 mg/dL.
For an online assessment of your risk,
take the “Learn and Live” quiz at
www.americanheart.org.
July/August 2005
27
John Kawie’s
Life
at the
curb
Operation
“Stroke-Proof”
I had my stroke on
my honeymoon and lost the use of
my left arm and leg. I was in two
different hospitals for a total of two
months, 47 years old, and facing
what seemed to me an eternity of
rehab. I couldn’t wait to escape and
get back home to my apartment in
New York City. Even though I knew
I wasn’t magically cured (after all,
Ladies and gentlemen...
I was still in a wheelchair), I was
learning to walk with a cane. Still, I
please welcome comedian
was no Lance Armstrong.
and stroke survivor john
Before my release date, the
hospital, apparently concerned
kawie as we debut his
John Kawie
for my well-being, sent a team of
regular humor column,
therapists to my apartment to make sure it was physically safe for me. Evidently they
were going to stroke-proof it, like you child-proof an apartment. I thought these must
“Life at the curb.”
be the CVA FSST: The Cerebral Vascular Accident Feng Shui Stroke Team.
Here is what I expect the guidelines must be to complete a stroke-proofing
procedure. (Insert Mission Impossible music)
9 a.m.: Enter apartment. Immediately notice area rugs just lying there
waiting to be tripped over. Instantly spring into action and rip duct tape off the
rolls hanging off your toolbelt. Secure the area (rugs, that is) by taping them to the
floor. Use as much tape as possible because the hospital is paying for it and this
guy’s insurance is paying the hospital. The survivor may complain his apartment
looks like it’s being shipped to Anchorage, Alaska. Suggest that he take his name
off the door and write “Fragile. This end up.”
11 a.m.: Having run out of tape, hit the
bathroom. The priority here is the toilet. Replace
The hospital sent to my apartment the regular toilet seat with the higher stroke
the CVA FSST: The Cerebral Vascular survivor regulation seat. Code name: The
Accident Feng Shui Stroke Team. Matterhorn.
The survivor may complain because he’ll need
a ladder to get to the toilet and he probably can’t
even go up stairs yet. Ease his mind by telling him once he gets on the toilet his
feet will dangle like he is potty training again, allowing him to relive those innocent
moments of his youth, though he may need Dramamine to go to the bathroom.
12 p.m.: Turn your attention to the shower. Install bars in the shower. No
need to concern yourself with where to install the bars, just install them all over. The
survivor may feel like he’s showering in a jungle gym. Reassure him that all he needs
is a slide coming off the toilet and his whole bathroom would be a playscape. Again,
just like when he was a kid.
1 p.m.: Recommend the survivor have a healthcare attendant with him at
all times because it’s not safe for him to be alone in his own apartment. Well, the
hospital calls them healthcare attendants. But after meeting my first one, Maurice,
I call them babysitters or convicted felons. But that’s a whole other story…
28
Editor’s Note: Read John’s personal stroke story, “Life is at the Curb,” from the September/October
2003 issue of Stroke Connection at strokeassociation.org/strokeconnection, or book his one-man
show about stroke recovery, “Brain Freeze,” by contacting him at [email protected].
July/August 2005
know...
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OF STROKE:
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• Sudden, severe headache with
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July/August 2005
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
Without a Prescription:
What You Need to Know
About OTC Medicines by Sam Gaines
Decongestants: Contain
pseudoephedrine to narrow the
blood vessels in the lining of your
nose, reducing the amount of
swelling in your nasal passages.
Cough medicines: Two types
— antitussives (which suppress
coughing) and expectorants
(which clear mucus from the
airways, so coughing is better able
to clear it away).
Medicine Dos and Don’ts
Medicines sold without a
prescription are called over-thecounter (OTC) medicines.
About 1,000 active ingredients are
present in more than 100,000 OTC
products, reported the Consumer
Healthcare Products Association in
2001. Retail sales for OTC meds
reached $17.2 billion in 2002 — and
that doesn’t include Wal-Mart,
according to ACNielsen researchers.
The positive impact that OTC
medications have on our health is
also considerable. Northwestern
University researchers found that
OTCs used to treat upper respiratory
infections saved consumers $4.75
billion in 2004.
Because OTC medications are so
readily accessible and affordable,
we often think little of taking them.
While OTC medicines are safe, they
can present problems if taken with
prescription medications that can
30
July/August 2005
interact with their active ingredients.
That’s why it’s so important to tell
your doctor and pharmacist what
OTC medications you use, and to
keep them up to date.
Types of OTC Medications
OTC medicines most commonly used
fall into four main categories:
Pain relievers: Commonly used
for treating everything from
minor headaches and chronic
pain to fever. Aspirin is the most
familiar type, but the category
also includes nonsteroidal antiinflammatory drugs (NSAIDs) such
as ibuprofen and naproxen, as well
as acetaminophen.
Antihistamines: Effective in
fighting cold, flu and allergy
symptoms, especially the itching,
sneezing and runny nose that often
accompany these ailments.
Safety is the key word for all
medicines. You can be sure you’re
using medicine safely by following a
few basic guidelines:
• Do read the label carefully.
• Do take your medicine exactly as
your doctor tells you to.
• Do make sure that each of your
doctors and your pharmacist has
a list of all the medicines you’re
taking.
• Do ask your doctor or
pharmacist questions about your
medications, supplements and
any possible interactions.
• Do make sure everyone you
live with knows what medicines
you’re taking and when you’re
supposed to take each one.
• Don’t combine prescription
medicines with OTC medicines
unless your doctor says it is OK.
• Don’t take anyone else’s medicine.
• Don’t use medicine after its expiration date.
• Don’t crush, break or chew tablets or capsules unless
your doctor tells you to. Some medicines aren’t
effective unless they are swallowed whole.
Get Informed, Stay Informed
Understanding your OTC medicines and how they may
interact with your prescription medications is essential.
Of course, the more prescription medications you take, the
more important it is to understand how they interact, and
how they may interact with any OTC medicines you are
considering.
One good way to get information about your OTC
medicine is to read the label. If you understand what you’re
looking at, you might find answers to your questions there.
Here’s what to look for:
Active ingredient. This is the chemical compound that
does the actual work of the medicine. Sometimes there
is more than one.
Uses. Sometimes called “indications,” these are the
symptoms that the medicine is supposed to treat. The
FDA must approve these listings.
Warnings. Pay close attention to this information.
It’s a listing of what medicines, foods or situations to
avoid while using this medication.
Directions. This information will tell you how much
and when to take the medicine.
Other information. If there are any other special
instructions for how to store or use the medicine, they
will appear here.
Inactive ingredients. Every medicine includes some
compounds that, while serving no purpose in
treating symptoms, play important roles in holding
the compounds together, preserving the active
ingredients, etc.
Questions or comments. Here’s where you find the
toll-free number to call if you have any questions or
comments about the medicine.
Effects and
Interactions
Any drug can cause side effects. Many side effects are
mild, but some can be severe. In addition, many drugs
can interact with other drugs, or even with food or OTC
medicines. These interactions can also range from
minor to life-threatening. That’s why taking care to avoid
dangerous interactions is always a smart idea.
Here are a few well-known drug-drug and drug-food
interactions:
Aspirin and blood-thinners, such as warfarin, can
lead to excessive bleeding.
Certain antacids can prevent some medications, such
as antibiotics, blood-thinners and heart medications,
from being properly absorbed into the blood, making the
medicine less effective than it should be — or completely
ineffective.
Decongestants can interact with anti-hypertension
drugs or MAO-inhibiting antidepressants to cause harmful
increases in blood pressure.
Some herbal supplements can interact with
medications to cause significant problems, too. For
example, ginkgo inhibits blood clotting, which can cause
serious problems if taken by someone on anticoagulants
or blood thinners. Also, kava kava can add to the effects of
muscle relaxants, sedatives and antidepressants.
Vitamins and minerals can also interact with your
medicines. Ferrous sulfate — a type of iron — can cancel
out the effects of tetracycline, a frequently prescribed
antibiotic.
Certain foods and beverages can also interfere with the
effectiveness of your medicines. For example, grapefruit
juice can cause problems with some blood pressurelowering medicines, the antihistamine terfenadine and
the transplant rejection-countering drug cyclosporine.
And alcohol can interact negatively with a variety of
prescription and OTC medicines.
The best ways to learn about what effects and potential
interactions your OTC medicines, herbal supplements,
and vitamins and minerals may cause is to read the labels
carefully and talk with your doctor and pharmacist.
Sources:
http://nihseniorhealth.gov/takingmedicines/toc.html
http://www.fda.gov/cder/consumerinfo/WhatsRightForYou.htm
It’s a good idea to get help from family or friends with
understanding and taking your medications. It’s also smart to
keep a record that shows clearly what each medicine is, how
often you should take it, any special instructions about taking
it, and when you are taking each medicine each day.
http://familydoctor.org/otc.xml
http://www.fda.gov/cder/consumerinfo/OTClabel.htm
http://www.niapublications.org/engagepages/medicine.asp
July/August 2005
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
Herbal Remedies and Dietary
Supplements: Buyer Beware
They often look professionally packaged and
carefully labeled with health information, but the fact
is that herbal remedies and dietary supplements
are not governed by the same rigorous testing and
requirements that prescription medicines must go
through. Thus, there is no way of knowing for sure
whether what the label says is the same as what’s
actually in the product.
If you use these products, be sure to tell your doctor
and pharmacist what you’re using, how much and
how often. Even if supplements and herbal remedies
are truthfully labeled and properly manufactured,
there’s no guarantee they’re safe. Just because
something is advertised as “organic” or “natural”
doesn’t mean it’s good for your health.
The National Council on Patient
Information and Education
MedlinePlus Drug
Information Listings
A March 2005 Harris Interactive Poll found that 33
percent of Americans report that they often or very often
do not comply with their prescription’s directions. The
National Council on Patient Information and Education
wants to change that.
An A to Z listing of prescription and OTC
medications (both by brand name and generic
name), this site within the National Library of
Medicine’s Web presence is a comprehensive
database of indications, known side effects,
storage guidelines, special instructions and
much more for every medicine on the market
now. If you lose the patient information sheet
that comes with medications, you can look up
the information here any time you like.
A 22-year-old patient advocacy group, NCPIE is a diverse
coalition of more than 130 organizations dedicated to safer,
more effective medicine use through better communication.
The council’s TalkAboutRx.org Web site helps consumers
make sound decisions about using their prescription
medications. A companion site, BeMedWise.org, does the
same for over-the-counter medications.
http://www.talkaboutrx.org
http://www.bemedwise.org
NCPIE
4915 Saint Elmo Ave., Suite 505
Bethesda, MD 20814-6082
(301) 656-8565
32
July/August 2005
http://www.nlm.nih.gov/medlineplus/
druginformation.html
U.S. National Library of Medicine
8600 Rockville Pike
Bethesda, MD 20894
Toll free: 1-888-FIND-NLM (346-3656)
Local and international calls: (301) 594-5983
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
compared with 0.3% for placebo + aspirin.
Adverse events occurring in �2.5% of patients on PLAVIX in the CAPRIE controlled
clinical trial are shown below regardless of relationship to PLAVIX. The median duration of therapy was 20 months, with a maximum of 3 years.
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)
% Incidence (% Discontinuation)
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
% Incidence (% Discontinuation)
Body System
PLAVIX
Placebo
(+ aspirin)*
(+ aspirin)*
Event
[n=6259]
[n=6303]
Body as a Whole- general disorders
Chest Pain
2.7 (<0.1)
2.8 (0.0)
Central & peripheral nervous system disorders
Headache
3.1 (0.1)
3.2 (0.1)
Dizziness
2.4 (0.1)
2.0 (<0.1)
Gastrointestinal system disorders
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.
Brief Summary of Prescribing Information Rev. November 2004
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