Semin Thromb Hemost 2015; 41(07): 774-787
DOI: 10.1055/s-0035-1564042
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Gender Difference in Efficacy and Safety of Nonvitamin K Antagonist Oral Anticoagulants in Patients with Nonvalvular Atrial Fibrillation or Venous Thromboembolism: A Systematic Review and a Meta-Analysis of the Literature

Francesco Dentali
1   Department of Clinical and Experimental Medicine, Insubria University, Varese, Italy
,
Anna Paola Sironi
1   Department of Clinical and Experimental Medicine, Insubria University, Varese, Italy
,
Monica Gianni
2   Department of Cardiology, Tradate Hospital, Tradate, Italy
,
Francesco Orlandini
3   Department of Internal Medicine, Ligurian East Hospital, La Spezia, Italy
,
Luigina Guasti
1   Department of Clinical and Experimental Medicine, Insubria University, Varese, Italy
,
Anna Maria Grandi
1   Department of Clinical and Experimental Medicine, Insubria University, Varese, Italy
,
Massimo Franchini
4   Department of Transfusion Medicine and Hematology, Azienda Ospedaliera Carlo Poma, Mantova, Italy
,
Walter Ageno
1   Department of Clinical and Experimental Medicine, Insubria University, Varese, Italy
,
Alessandro Squizzato
1   Department of Clinical and Experimental Medicine, Insubria University, Varese, Italy
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Publikationsdatum:
26. September 2015 (online)

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Abstract

Introduction Limited information exists on gender-related differences in the safety and efficacy of non-vitamin K antagonist oral anticoagulants (NOACs).

Aim of the Study To assess the safety and efficacy of direct oral anticoagulants (DOACs)/NOACs in men and women pooling data from randomized controlled trials on the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF) and on the acute and extended treatment of venous thromboembolism (VTE).

Methods MEDLINE and EMBASE databases were searched up to June 2014. The efficacy outcome was defined as the prevention of stroke and systemic embolism (AF studies), or as the prevention of recurrent VTE or VTE-related death (VTE studies). The safety outcome was defined as the occurrence of major and/or clinically relevant nonmajor bleeding. Differences in the efficacy and safety outcomes were expressed as risk ratio (RR) with pertinent 95% confidence intervals (95% CI).

Results A total of 13 studies (> 100,000 patients) were included. DOACs appeared to have a similar efficacy and safety compared with vitamin K antagonists in female and male patients treated for nonvalvular AF and acute VTE. In the extended treatment of VTE NOACs had a RR of bleeding of 4.97 (95% CI 1.06, 23.41) in males and 1.33 (95% CI 0.63, 2.83) in females compared with placebo (subgroup difference chi-square test: 2.25, p = 0.13).

Conclusions No gender-related difference in the efficacy and safety of NOACs in patients with AF or acute VTE was found. A trend toward an increased risk of bleeding in male patients as compared with female patients was detected in the extended treatment of VTE.

Note

The authors have no conflict of interest to declare.