Study shows no benefit of adding Plavix, Iscover to aspirin therapy to reduce risk of heart attack

By E. Janene Geiss

Philadelphia, March 13 - Results of a sanofi-aventis and Bristol-Myers Squibb Co.-supported trial showed the combination of the antiplatelet agents clopidogrel and aspirin did not demonstrate a statistically significant reduction in the risk of heart attack, stroke or cardiovascular death compared to a placebo and aspirin in a broad population of patients with either established atherothrombotic disease or multiple risk factors for atherothrombotic events.

Analysis of the two main patient subgroups of the study, entitled "Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance (Charisma)," revealed different responses to clopidogrel and aspirin therapy, according to a news release.

In patients with established atherothrombotic disease, the Charisma findings demonstrated clopidogrel in addition to aspirin and other standard therapy reduced the relative risk of a recurrent heart attack, stroke or cardiovascular death by a statistically significant 12.5% compared to patients receiving a placebo and aspirin. These patients accounted for nearly 80% of the total Charisma study population, officials said.

Overall, the study showed that there was no significant benefit to adding clopidogrel to aspirin therapy in a wide range of patients, according to a news release from Bayer Consumer Care division, maker of Bayer aspirin.

Furthermore, since patients who took clopidogrel had an increased risk of bleeding, the long-term use of combination antiplatelet therapy may not be warranted in most patients, Bayer officials said.

"Charisma reaffirms the favorable benefit-to-risk and benefit-to-cost ratio of aspirin in the treatment and prevention of heart attack and stroke," Charles H. Hennekens, professor at Florida Atlantic University and the University of Miami School of Medicine, who pioneered many early landmark trials of aspirin, said in the Bayer release.

Officials from sanofi-aventis and Bristol-Myers reiterated those results, saying that patients with multiple risk factors, but no clearly established vascular disease, did not benefit from the addition of clopidogrel to aspirin. These patients represented about 20% of the overall study population.

Actually, in this patient subgroup there was an excess in cardiovascular mortality as well as a non-statistically significant increase in bleeding observed in patients treated with clopidogrel and aspirin, officials said.

Results of the Charisma trial were presented Sunday at the 55th Annual Scientific Session of the American College of Cardiology meeting in Atlanta.

The Charisma trial was coordinated by the Cleveland Clinic Cardiovascular Coordinating Center group. The primary investigator of the trial was Dr. Deepak Bhatt, and the study was chaired by Professor Eric Topol. The trial was supported by grants from sanofi-aventis and Bristol-Myers Squibb.

Clopidogrel, marketed as Plavix and Iscover, is approved for early and long-term risk reduction in patients at risk for atherothrombotic events. The long-term efficacy and safety of clopidogrel has been studied in landmark clinical trials in more than 100,000 patients and in clinical practice in millions of patients treated worldwide. Clopidogrel is marketed worldwide by sanofi-aventis and Bristol-Myers Squibb.

Sanofi-aventis is a Paris pharmaceutical company, developing positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine and vaccines.

Bristol-Myers Squibb is a New York pharmaceutical and related health care products company.

Bayer Consumer Care is a division of Bayer HealthCare LLC, based in Morristown, N.J., and among the largest marketers of over-the-counter medications and nutritional supplements in the world. Bayer HealthCare is a subsidiary of Bayer AG, a health care and medical products company based in Leverkusen, Germany.

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