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September 2002

From: Bristol-Meyer Squibb

Announcing a new indication for PLAVIX® (Clopidogrel bisulfate) 75 mg tablets in patients with acute coronary syndrome (unstable angina/non-Q-wave MI)

Dear Healthcare Provider:

We are pleased to announce that the U.S. Food and Drug Administration (FDA) has approved the antiplatelet medication Plavix® (Clopidogrel bisulfate) for a new indication-acute coronary syndrome (ACS).

For patients with acute coronary syndrome (unstable angina/non-Q-wave MI), including patients who are to 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 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.

This new indication for PLAVIX is based on results from the landmark CURE (Clopidogrel in Unstable Angina to Prevent Recurrent Events) study of 12,562 patients. Patients were randomized to PLAVIX (300-mg loading dose followed by 75mg/day) or placebo, both given in combination with aspiring (75-325 mg once daily for up to 1 year. Patients also received other standard therapy. The use of GPIIb/IIIa inhibitors was not permitted for 3 days prior to randomization.

Efficacy

PLAVIX + Aspirin versus Placebo +Aspirin:

PLAVIX provided a 20% relative risk reduction in the combined end point of MI, stroke, and cardiovascular death (9.3 % in the PLAVIX + ASA-treated group and 11.4% in the placebo +ASA- treated group , P=0.00009).
PLAVIX also provided a relative risk reduction of 14% in the co-primary combined end point of MI, stoke, CV death, and refractory ischemia (16.5% in the PLAVIX + ASA-treated group and 18.8% in the placebo +ASA-treated group, P=0.0005).
Benefits of PLAVIX were seen early and maintained throughout the course of the trial (up to 1 year).
Benefits of PLAVIX were maintained with or without revascularization and independently of the dose of aspiring or the use of IV GPIIb/IIIa inhibitors, heparin/LMWH, lipid-lowering agents, beta blockers, or ACE inhibitors.

Clinical Profile

PLAVIX + Aspirin versus Placebo +Aspirin:

Safety and tolerability demonstrated in the CURE trial.
The risk of major and minor bleeding was increased (major bleeding: 3.7% vs 2.7%, respectively, P=0.001; minor bleeding: 5.1% vs 2.4% respectively, P<0.001).

Dosage and Administration

In ACS (unstable angina/non-Q-wave MI), PLAVIX should be initiated with a single 300-mg loading dose then continued at 75 mg once daily ( in combination with aspirin 75-325 mg once daily). In CURE, most patients with ACS also received heaprin acutely.

To learn more about the use of PLAVIX, visit www.plavix.com.

Important Risk Information

Plavix® (clopidogrel bisulfate) is contraindicated in patients with active pathologic bleeding such as peptic ulcer or intracranial hemorrhage. As with other antiplatelet agents, 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.
The rates of major and minor bleeding were higher in patients treated with PLAVIX plus aspirin compared with placebo plus aspiring in a clinical trial .
As part of the worldwide postmarketing experience with PLAVIX, suspected cases of thrombotic thrombocytopenic pruprua (TTP) 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 requiring prompt treatment.
In clinical trials, the most common clinically important side effects were pruritus, prupura, diarrhea, and rash; infrequent events included intracranial hemorrhage (0.4%) and severe neutropenia (0.05%).

Please see accompanying full prescribing information.

Sincerely,

Chitra Sekaran, M.D. Senior Medical Director

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