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First-Ever Guidelines Issued for Management of Peripheral Artery Disease

NEW YORK, N.Y. -- March 24, 2006 -- Up to twelve million people in the U.S. are affected by peripheral artery disease (PAD), a serious condition where arteries in the legs become narrowed or clogged due to the formation of plaque, increasing a patient's risk of suffering a heart attack or stroke.1,2

For the first time, the American College of Cardiology and American Heart Association have released treatment guidelines for PAD.

As defined in the new PAD guidelines, the risk of heart attack and stroke associated with PAD can be reduced through early diagnosis, lifestyle changes and appropriate medicines including Plavix.

Dr. Peter Sheehan, hospital for joint diseases orthopedic institute, New York, said, "These new guidelines are helpful in diagnosing and treating people with P.A.D. and its associated cardiovascular risks. The guidelines define appropriate therapies including the use of anti-platelet medicines such as Plavix(R) (clopidogrel bisulfate), which can help reduce the risk of heart attack or stroke."

If you have a stomach ulcer or other condition that causes bleeding, you shouldn't use Plavix. When taking Plavix alone or with some medicines including aspirin, the risk of bleeding may increase. To minimize this risk, talk to your doctor before taking aspirin or other medicines with Plavix. Additional rare but serious side effects could occur.

Dr. Peter Sheehan is a consultant for the Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership.

Who should receive Plavix(R) (clopidogrel bisulfate)?
Plavix is indicated for the reduction of atherothrombotic events as follows:

* Recent Myocardial Infarction (MI), Recent Stroke, or Established Peripheral Arterial Disease (PAD)

For patients with a history of recent MI, recent stroke, or established PAD, Plavix has been shown to reduce the rate of a combined end point of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death.

* Acute Coronary Syndrome (ACS)

For patients with ACS (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 coronary artery bypass graft surgery (CABG), Plavix has been shown to decrease the rate of a combined end point of cardiovascular death, MI, or stroke as well as the rate of a combined end point of cardiovascular death, MI, stroke, or refractory ischemia.

Important Risk Information:
* Plavix is contraindicated in patients with active pathologic bleeding such as peptic ulcer or intracranial hemorrhage. Plavix should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery, or coadministration with NSAIDs or warfarin. (See CONTRAINDICATIONS and PRECAUTIONS.**)

* The rates of major and minor bleeding were higher in patients treated with Plavix plus aspirin compared with placebo plus aspirin in a clinical trial. (See ADVERSE REACTIONS. **)

* As part of the worldwide postmarketing experience with Plavix, suspected cases of thrombotic thrombocytopenic purpura (TTP), some with fatal outcome, have been reported at a rate of about 4 cases per million patients exposed. 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. (See WARNINGS.**)

* In clinical trials, the most common clinically important side effects were pruritus, purpura, diarrhea, and rash; infrequent events included intracranial hemorrhage (0.4%) and severe neutropenia (0.05%). (See ADVERSE REACTIONS.**)


SOURCE: Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership

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