Plavix helps heart attack treatment

Results of two major clinical studies have shown that the antiplatelet agents clopidogrel (Plavix), given the high level of the therapy, provided significant benefits to patients with severe ST segment elevation myocardial infarction (STEMI), a certain type of heart attack. Results of the COMMIT/CCS-2 (ClOpidogrel and Metoprolol in Myocardial Infarction Trial) and CLARITY - TIMI 28 (CLopidogrel as booster ReperfusIon TherapY - Thrombolysis in Myocardial Infarction Study 28), testing, which included a total of nearly 50,000 patients were presented today in Orlando, Florida, at the 54th Annual Scientific Session of the American College of Cardiology (ACC). In the CLARITY - TIMI 28 trial, clopidogrel added to standard treatment, including fibrinolytics and ASA (aspirin) reduced the odds of acute MI patients with arterial occlusion, or a second heart attack or death by 36 percent after one week hospitalization (Event rate: 15.0 percent in the clopidogrel arm against 21.7 percent in the placebo group, P <0.001). In addition, thirty days, clopidogrel reduced the probability of clinical events (cardiovascular death, recurrent myocardial infarction, recurrent ischemia leading to urgent revascularization) in these patients by 20 percent (Event rate: 11, 6 percent from 14.1 percent, P = 0.03). The results observed with clopidogrel in this clinical setting were consistent regardless of patient gender, the standard treatment received (type of fibrinolytic or type of heparin) or the location of their MI. The CLARITY - TIMI 28 trial enrolled 3,491 patients at 319 sites in 23 countries in North America, Latin America and Europe. The trial was coordinated by the TIMI (Thrombolysis in Myocardial Infarction), chaired by Eugene Braunwald, M.D., Distinguished Hersey Professor of Medicine, Harvard Medical School and Brigham and Women's Hospital. "Re-occlusion of coronary arteries in acute MI patients has been shown to occur more often," said Braunwald. "The CLARITY - TIMI 28 trial demonstrated treating acute MI patients with clopidogrel, on top of standard therapy of aspirin and fibrinolytics, resulted in a 36 per cent reduction in anticipation of a blocked artery or the death or recurrent myocardial infarction at the time of angiography. " In the COMMIT/CCS-2 trial clopidogrel, on top of the standard therapy including ASA, reduced mortality in patients with acute MI. Within 28 days after randomization, clopidogrel reduced the relative risk of death in these patients by 7 percent (Event rate: 7.5 percent versus 8.1 percent; P = 0.03). In the same patient population, clopidogrel reduced the relative risk of the combination of recurrent MI, stroke or death by 9 percent (Event rate: 9.3 percent versus 10.1 percent; P = 0.002). The COMMIT/CCS-2 trial, one of the largest randomized double-blind placebo-controlled clinical trials of drug therapy ever conducted in heart disease, enrolled nearly 46,000 patients at 1,250 sites in China. The trial was coordinated by the University of Oxford, U.K. And the Fuwai Hospital, Chinese Academy of Medical Sciences, China, and was co-chaired by Rory Collins M.D. And LS Liu, M.D. "The COMMIT/CCS-2 study showed that clopidogrel reduced mortality in a hospital setting," said Zheng Ming Chen, M.D., Oxford University. "The study also showed that there was no significant increase in the risk of fatal or transfused bleeding associated with clopidogrel therapy." In both trials, the rates of major bleeding and intracranial hemorrhage were similar in both treatment groups. In the CLARITY - TIMI 28 study, there was no statistically significant difference in the incidence of major bleeding and primary intracranial hemorrhage. The rate of major bleeding in the clopidogrel group was 1.3 percent compared with 1.1 percent in the placebo group (p = 0.64), on top of the standard therapy group (including fibrinolytics and ASA). In COMMIT/CCS-2, no significant increase in the risk of death or transfused bleed was observed. The rate of major, non - cerebral bleeding was 0.4 percent in the clopidogrel compared with 0.3 percent in the placebo group on the top of the standard, including the ASA group therapy (P = 0.52). In addition, the rate of intracranial hemorrhage was very low and similar in all groups clopidogrel and placebo. Of the 10 million estimated IM per year worldwide, 3 million are STEMI. MI remains an early and long-term life-threatening. The long-term efficacy and safety of clopidogrel has been established through landmark clinical trials in 100,000 patients and with clinical experience in 41 million patients worldwide since its launch. Clopidogrel has demonstrated early and long term protection of the thrombotic patient in multiple trials: unstable angina and NSTEMI (CURE), thrombosis including recent MI, ischemic strokes recent, or symptomatic peripheral artery disease (CAPRIE). Based on these new clinical data aventis and Bristol-Myers Squibb plan to meet with health authorities and discuss these results and their support for an indication. The CLARITY - TIMI 28 and COMMIT / CCS 2 trials were supported by aventis and Bristol-Myers Squibb. Clopidogrel is marketed worldwide by aventis (Paris Bourse: EURONEXT: SAN; New York: NYSE: SNY) and Bristol-Myers Squibb Company (NYSE: BMY), and Plavix Iscover. About Plavix (clopidogrel bisulfate). PLAVIX is indicated for the reduction of thrombotic events as follows: Recent myocardial infarction (MI), recent stroke, or Established Peripheral Artery 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. Risk important information: PLAVIX is contraindicated in patients with pathological bleeding such as peptic ulcer or intracranial bleeding. As with other antiplatelet agents, PLAVIX should be used with caution in patients who may be at increased risk of bleeding from trauma, surgery, or coadministration with NSAIDs or warfarin. (See CONTRAINDICATIONS and PRECAUTIONS .*) The rate of major and minor bleeding were higher in patients treated with PLAVIX and aspirin compared with placebo and aspirin in a clinical trial. (See REACTIONS .*) As part of the world after the release of PLAVIX, suspected cases of thrombotic thrombocytopenic purpura (TTP), some fatal, have been reported at a rate of about four 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 side effects were clinically significant pruritus, purpura, diarrhea and rash; rare events included intracranial hemorrhage (0.4 percent) and severe neutropenia (0.05 percent ). (See REACTIONS .*) Plavix Prescribing full information Visit www.plavix.COM. For further information, please contact: Media-Tracy Furey, Bristol-Myers Squibb, 609-273-4697; Jean-Marc Podvin, aventis, 33-1-53-77-4223; Investors-John Elicker, Bristol - Myers Squibb, 212-546-3775; Sanjay Gupta, aventis, 3-1-53-77-4545, 212-551-4293 This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. These forward-looking statements are based on current expectations and involve risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual results to differ materially from current expectations. No forward-looking statement can be guaranteed. More specifically, there can be no guarantee that health authorities will approve an additional indication as mentioned above. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb of the business, particularly those identified in the cautionary statement in the discussion of the factors of Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2004 and in our quarterly reports on Form 10-Q. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.