In:
Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 116, No. suppl_16 ( 2007-10-16)
Abstract:
Background : Previous analyses have demonstrated sex-based differences in the efficacy of several anti-platelet medications. Little is known about the safety and efficacy of clopidogrel in women and men. Methods : We performed a meta-analysis of all blinded randomized clinical trials comparing clopidogrel and placebo (CREDO, CURE, CLARITY-TIMI 28, COMMIT, and CHARISMA). The relative safety and efficacy of clopidogrel at reducing cardiovascular events (death, MI or stroke) in women and men was estimated using random-effects modeling. Results : In all 79,613 patients, there was a reduction of cardiovascular events with clopidogrel vs placebo (9.7% vs 8.7%; OR 0.88 [0.84–0.93], P 〈 0.01). Among the 23,522 women enrolled, there were 1289/11757 (11.0%) cardiovascular events in the clopidogrel group vs. 1372/11766 (11.7%) in the placebo group (OR 0.93 [0.86–1.01] , P=0.09). Clopidogrel had its greatest effect in reducing the risk of MI (OR 0.82 [0.70–0.95], P=0.01) in women. No significant reduction was noted for stroke (OR 0.91 [0.67–1.24] , P=0.56) or death (OR 0.99 [0.90–1.08], P=0.78). Among the 56,091 men enrolled, there were 2166/28064 (7.7%) cardiovascular events in the clopidogrel group vs 2492/28027 (8.9%) in the placebo group (OR 0.85 [0.79–0.91] , P 〈 0.01). Clopidogrel significantly reduced the risk of MI (OR 0.84 [0.76–0.92], P 〈 0.01), stroke (OR 0.83 [0.71–0.96], P=0.01), and death (OR 0.91 [0.84–0.98] , P 〈 0.01). Clopidogrel increased the risk of major bleeding in both women (1.6% vs 1.1%, OR 1.43 [1.14–1.79]) and men (1.2% vs 1.0%, OR 1.21 [1.03–1.42] ). The safety and efficacy were similar in patients with an acute coronary syndrome and established cardiovascular disease. There was no evidence of statistical heterogeneity (as measured by the Q-test and I 2 ) in pooled analyses comparing women and men for the composite endpoint, its individual components, or bleeding. Conclusions : Clopidogrel reduces the risk of cardiovascular events in both women and men. While the directionality and proportionality of the reductions are roughly similar, the effect was driven by a reduction of MI in women. The reduction of MI, stroke and death by clopidogrel in men were all significant. Clopidogrel increased the risk of major bleeding by 43% in women and 21% in men.
Type of Medium:
Online Resource
ISSN:
0009-7322
,
1524-4539
DOI:
10.1161/circ.116.suppl_16.II_483
Language:
English
Publisher:
Ovid Technologies (Wolters Kluwer Health)
Publication Date:
2007
detail.hit.zdb_id:
1466401-X
