Do women bleed more than men when prescribed novel oral anticoagulants for venous
thromboembolism? A sex-based meta-analysis.
Author(s): Alotaibi GS(1), Almodaimegh H, McMurtry MS, Wu C.
Affiliation(s): Author information:
(1)Department of Medicine, University of Alberta, Canada.
Publication date & source: 2013, Thromb Res. , 132(2):185-9
INTRODUCTION: Bleeding complications occur more frequently in women than men in
clinical trials of warfarin and thrombolytics. It is unknown whether these
sex-related differences exist for new oral anticoagulants, including dabigatran,
rivaroxaban, and apixaban. To determine whether women suffer more bleeding
complications with these agents, we conducted a systematic review and
meta-analysis of randomized controlled trials on new oral anticoagulants for
venous thromboembolism (VTE).
MATERIALS AND METHODS: Medline, Embase, and the Cochrane-controlled trial
register on the Cochrane library were searched to identify studies that evaluated
novel oral anticoagulants versus any comparator, and reported outcomes, including
major bleeding and recurrent VTE, stratified by sex. No language restrictions
were applied. Studies were evaluated according to a priori inclusion criteria and
critically appraised using established internal validity criteria. Pooled
relative risk was estimated using a random effects model.
RESULTS: Eight studies were eligible, comprising 9417 patients. There was no
difference in the primary efficacy outcome of recurrent VTE between men and women
[Relative Risk (RR) 1.02, 95% confidence interval (CI) 0.74-1.39]. However, men
had less major bleeding with novel oral anticoagulants compared to women [RR
0.79, 95% CI 0.66-0.97, p=0.03]. All-cause mortality was not reported by sex in
any of the studies.
CONCLUSION: Women suffer more bleeding complications than men when receiving
novel oral anticoagulants for VTE. Future clinical trials should report outcomes
stratified by sex, and further studies are needed to investigate the clinical
impact of this sex-related safety difference.
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