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CLINICAL RESEARCH: ANTITHROMBOTIC THERAPY

The Relative Efficacy and Safety of Clopidogrel in Women and Men

A Sex-Specific Collaborative Meta-Analysis

Jeffrey S. Berger, MD^_*,_*, Deepak L. Bhatt, MD, MPH^,, Christopher P. Cannon, MD, Zhengming Chen, MBBS, DPhil, Lixin Jiang, MBBS, MSc^||, James B. Jones, PhD, MBA, Shamir R. Mehta, MD^¶, Marc S. Sabatine, MD, MPH^,#, Steven R. Steinhubl, MD, Eric J. Topol, MD^_** and Peter B. Berger, MD

^_* New York University School of Medicine, New York, New York
VA Boston Healthcare System, Boston, Massachusetts
Brigham and Women's Hospital, Boston, Massachusetts
University of Oxford, Oxford, England
^|| Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China
^¶ McMaster University, Hamilton, Ontario, Canada
^# Harvard Medical School, Boston, Massachusetts
^_** Scripps Translational Research Institute, La Jolla, California
Geisinger Clinic, Danville, Pennsylvania

Manuscript received December 2, 2008; revised manuscript received May 11, 2009, accepted May 26, 2009.

^_* Reprint requests and correspondence: Dr. Jeffrey S. Berger, New York University School of Medicine, 530 First Avenue, Skirball 9R, New York, New York 10016 (Email: jeffrey.berger{at}nyumc.org).

Objectives: This study sought to investigate the efficacy and safety of clopidogrel in women and men.

Background: Previous analyses have shown sex-based differences in response to several antiplatelet medications. Little is known about the efficacy and safety of clopidogrel in women and men.

Methods: This study performed a meta-analysis of all blinded randomized clinical trials comparing clopidogrel and placebo (CURE [Clopidogrel in Unstable Angina to Prevent Recurrent Events], CREDO [Clopidogrel for the Reduction of Events During Observation], CLARITY–TIMI 28 [Clopidogrel as Adjunctive Reperfusion Therapy–Thrombolysis In Myocardial Infarction 28], COMMIT [Clopidogrel and Metoprolol in Myocardial Infarction Trial], and CHARISMA [Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance] trials), involving a total of 79,613 patients, of whom 30% were women. The relative efficacy and safety of clopidogrel at reducing cardiovascular events (cardiovascular death, myocardial infarction [MI], or stroke) in women and men was estimated using random-effects modeling.

Results: Overall, clopidogrel was associated with a highly significant 14% proportional reduction in the risk of cardiovascular events (odds ratio [OR]: 0.86; 95% confidence interval [CI]: 0.80 to 0.93), with no significant differences in treatment effect between women and men. Among the 23,533 women enrolled, there were fewer cardiovascular events in the clopidogrel group compared with the placebo group (11.0% vs. 11.8%; OR: 0.93; 95% CI: 0.86 to 1.01). In women the risk reduction with clopidogrel seemed to be greatest for MI (OR: 0.81; 95% CI: 0.70 to 0.93), with the effects on stroke (OR: 0.91; 95% CI: 0.69 to 1.21) or total death (OR: 0.99; 95% CI: 0.90 to 1.08) not statistically significant. Among the 56,091 men enrolled, there were fewer cardiovascular events in those receiving clopidogrel compared with placebo (7.8% vs. 9.0%; OR: 0.84; 95% CI: 0.78 to 0.91), and the risk reduction was significant for MI (OR: 0.83; 95% CI: 0.76 to 0.92), stroke (OR: 0.83; 95% CI: 0.71 to 0.96), and total death (OR: 0.91; 95% CI: 0.84 to 0.97). Clopidogrel increased the risk of major bleeding in both women (OR: 1.43; 95% CI: 1.15 to 1.79) and men (OR: 1.22; 95% CI: 1.05 to 1.42).

Conclusions: Clopidogrel reduces the risk of cardiovascular events in both women and men.

Key Words: sex • antiplatelet agents • clopidogrel • randomized trial • cardiovascular disease

Abbreviations and Acronyms   ACS = acute coronary syndrome   CI = confidence interval   MI = myocardial infarction   OR = odds ratio

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