He, Y; Wong, IC; Li, X; Anand, S; Leung, WK; Siu, CW; Chan, EW; (2016) The association between Non-vitamin K antagonist oral anticoagulants and gastrointestinal bleeding: a meta-analysis of observational studies. British Journal of Clinical Pharmacology , 82 (1) pp. 285-300. 10.1111/bcp.12911.

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Abstract

AIMS: Particular concerns have been raised regarding the association between Non-vitamin K antagonist oral anticoagulants (NOACs) and the risk of gastrointestinal bleeding (GIB); however current findings are still inconclusive. We conducted a systematic review with meta-analysis to examine the association between NOACs and GIB in real-life settings. METHODS: We performed a systematic search of PubMed, EMBASE, and CINAHL Plus up to September 2015. Observational studies that evaluated exposure to NOACs reporting GIB outcomes were included. The inverse variance method with random-effects model was used to calculate the pooled estimates. RESULTS: Eight cohort studies were included in the primary meta-analysis, enrolling 1,442 GIB cases among 106,626 dabigatran users (49,486 patient-years), and 184 GIB cases among 10,713 rivaroxaban users (4,046 patient-years). The pooled incidence rates of GIB were 4.50 (95%CI 3.17-5.84) and 7.18 (95%CI 2.42-12.0) per 100 patient-years among dabigatran and rivaroxaban users, respectively. The summary risk ratio (RR) was 1.21 (95%CI 1.05-1.39) for dabigatran compared to warfarin, and 1.09 (95%CI 0.92-1.30) for rivaroxaban. Subgroup analyses showed a dose effect of dabigatran, with a significantly higher risk of GIB for 150 mg bid (RR = 1.51, 95%CI 1.34-1.70) but not for 75 mg bid or 110 mg bid. In addition, the use of proton pump inhibitors (PPIs)/histamine-2 receptor antagonists (H2RAs) influenced the association in dabigatran users, whereas this effect was modest among rivaroxaban users. CONCLUSION: Our meta-analysis of real-life observational studies suggests a slightly higher risk of GIB with dabigatran use compared to warfarin, whereas no significant difference was found between rivaroxaban and warfarin for GIB risk.

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