Taking Plavix with Popular GI Medications Increases
Risk for Stroke, Heart Attack by 50%
Medco Health issues warning about second most popular
drug in the world and its reaction to proton pump inhibitors
Nov. 11, 2008 A report issued today warns that
taking the drug clopidogrel (brand name: Plavix), the second most
popular drug in the world, with proton pump inhibitors (PPIs) can
increase the risk for major cardiovascular problems by 50 percent and of
having a heart attack by 74 percent.. Medco Health Solutions, Inc.
presented the study at the 2008 Scientific Sessions of the American
Heart Association.
In the largest study of its kind to date,
researchers at Medco Health Solutions, Inc. report that PPIs inhibit the
effectiveness of clopidogrel, the number two prescription drug in the
world, thus increasing the risk of a major cardiac event, such as heart
attacks and strokes by 50 percent. Since PPIs mimic the effect of a
variant gene, which also renders clopidogrel ineffective, this study
further suggests a potential role for genetic testing.
Clopidogrel or Plavix is popular antiplatelet drug
for the prevention of blood clots that can lead to strokes and heart
attacks. (See more below news report.)
Proton pump inhibitors are an effective treatment
for gastroesophageal reflux disease (GERD), which is a more serious form
of gastroesophageal reflux (GER), which is common. PPIs include
omeprazole (Prilosec, Zegerid), lansoprazole (Prevacid), pantoprazole
(Protonix), rabeprazole (Aciphex), and esomeprazole (Nexium), which are
available by prescription. Prilosec is also available in
over-the-counter strength. (See more below news report.)
"Considering the widespread use of these two
medications, this important research adds to a growing body of evidence
raising questions about their concurrent use and suggests further
research is needed," said Dr. Robert Epstein, a lead study author, chief
medical officer, Medco.
"With this research in hand, we intend to open a
dialogue with the major clinical organizations to advance the discussion
around the guidelines that govern the use of Plavix."
Study details
Researchers tracked 16,690 patients who had
undergone a percutaneous coronary intervention such as stent placement
or balloon angioplasty, and had started taken clopidogrel as maintenance
therapy.
Of the patients in the study, 9,862 patients were
taking clopidogrel alone; and 6,828 patients were taking clopidogrel and
a PPI. Researchers tracked the two groups in the study for a 12-month
period using medical and pharmacy claims data.
Results of the study were striking: researchers
reported that the relative risk of a major adverse cardiovascular event
was 50 percent higher, and the relative risk of a heart attack
specifically was 74 percent higher, in patients taking both medications
together.
The incidence of a major cardiovascular event
within 12 months of starting clopidogrel was 25 percent for patients
taking both medications concurrently. The study was funded solely by
Medco.
Genetic variability and clopidogrel:
For clopidogrel to work, it must first be converted
to its active form by a liver enzyme called cytochrome P450 2C19. PPIs
interfere with this enzyme reducing the amount of clopidogrel that is
converted to an active form. The gene that produces this enzyme can vary
such that individuals can have more or less enzyme activity, thus
affecting its functionality. The way PPIs interfere with the conversion
of clopidogrel to an active form may mimic this genetic variation that
produces lower amounts of the enzyme, suggesting that genetic testing
for this enzyme may be useful. Other studies have shown that as many as
30 percent of people worldwide are born with this particular genetic
variation.
Alerting physicians to potential risk for
patients
Based upon this and other research on the issue,
Medco will begin alerting prescribing physicians through a range of
communications via its Medco Therapeutic Resource Centers (R) and other
channels so that prescribers can reconsider the risk/benefit of
concurrent prescribing of clopidogrel and PPIs based on their patients
individual circumstances.
Medco will also communicate its findings to various
clinical organizations to encourage continued dialogue around
prescribing guidelines for these two medications. Medco's researchers
plan to provide the findings to the Food and Drug Administration (FDA)
as part of their recently announced research collaboration in the area
of pharmacogenomics.
About Medco
Medco Health Solutions, Inc. (NYSE: MHS) is the
nation's leading pharmacy benefit manager based on its 2007 total net
revenues of more than $44 billion. Medco's prescription drug benefit
programs, covering approximately one-in-five Americans, are designed to
drive down the cost of pharmacy health care for private and public
employers, health plans, labor unions and government agencies of all
sizes, for individuals served by the Medicare Part D Prescription Drug
Program, and those served by Medco's specialty pharmacy segment, Accredo
Health Group. Medco, the world's most advanced pharmacy(R), is
positioned to serve the unique needs of patients with chronic and
complex conditions through its Medco Therapeutic Resource Centers(R),
including its enhanced diabetes pharmacy care practice through the
Liberty acquisition. Medco is the highest-ranked independent pharmacy
benefit manager on the 2008 Fortune 100 list. On the Net:
http://www.medcohealth.com.
More about Clopidogrel
Why is this medication prescribed? Clopidogrel is
used to prevent strokes and heart attacks in patients at risk for these
problems. Clopidogrel is in a class of medications called antiplatelet
drugs. It works by helping to prevent harmful blood clots.
How should this medicine be used?
Clopidogrel comes as a tablet to take by mouth. It
is usually taken once a day with or without food. Try to take
clopidogrel at around the same time every day. Follow the directions on
your prescription label carefully, and ask your doctor or pharmacist to
explain any part you do not understand. Take clopidogrel exactly as
directed. Do not take more or less of it or take it more often than
prescribed by your doctor.
Continue to take clopidogrel even if you feel well.
Do not stop taking clopidogrel without talking to your doctor.
Other uses for this medicine
Clopidogrel is also sometimes used to prevent blood
clots in people with mitral valve disease (a condition that affects the
valve that separates the left upper and lower chambers of the heart) and
people undergoing certain heart procedures. Talk to your doctor about
the possible risks of using this medication for your condition.
This medication may be prescribed for other uses;
ask your doctor or pharmacist for more information.
>>
More information at MedlinePlus
More About GERD and Proton Pump Inhibitors
Gastroesophageal reflux disease (GERD) is a more
serious form of gastroesophageal reflux (GER), which is common. GER
occurs when the lower esophageal sphincter (LES) opens spontaneously,
for varying periods of time, or does not close properly and stomach
contents rise up into the esophagus.
GER is also called acid reflux or acid
regurgitation, because digestive juicescalled acidsrise up with the
food. The esophagus is the tube that carries food from the mouth to the
stomach. The LES is a ring of muscle at the bottom of the esophagus that
acts like a valve between the esophagus and stomach.
When acid reflux occurs, food or fluid can be
tasted in the back of the mouth. When refluxed stomach acid touches the
lining of the esophagus it may cause a burning sensation in the chest or
throat called heartburn or acid indigestion. Occasional GER is common
and does not necessarily mean one has GERD. Persistent reflux that
occurs more than twice a week is considered GERD, and it can eventually
lead to more serious health problems. People of all ages can have GERD.
Photon Pump Inhibitors Sometimes Used for
Treatment
Proton pump inhibitors include omeprazole (Prilosec,
Zegerid), lansoprazole (Prevacid), pantoprazole (Protonix), rabeprazole
(Aciphex), and esomeprazole (Nexium), which are available by
prescription. Prilosec is also available in over-the-counter strength.
Proton pump inhibitors are more effective than H2 blockers and can
relieve symptoms and heal the esophageal lining in almost everyone who
has GERD.
>>
More information at National Digestive Diseases Information
Clearninghouse
