Safety of Dabigatran According to a Meta-Analysis of 7 Randomized Controlled Trials
Dabigatran is a direct thrombin inhibitor from the group of direct oral anticoagulants (DOACs), developed as an alternative to vitamin K antagonists. The aim of the recently published meta-analysis was to compare the risk of bleeding, fatal adverse events, and mortality in patients treated with dabigatran and conventional therapy.
Introduction
Dabigatran is a reversible direct thrombin inhibitor with rapid and predictable anticoagulant effects that do not require coagulation monitoring or dose adjustment, nor dietary restrictions for patients. Treatment with dabigatran has been shown to be cost-effective compared to warfarin – with better clinical outcomes and additional costs justified by the benefit in terms of overall survival and quality of life.
Systematic Review and Meta-Analysis of Studies
The aim of this meta-analysis was to gather data on the safety of anticoagulant treatment with dabigatran. The authors searched databases PubMed, Web of Science, Cochrane Library, Medline and others for randomized clinical trials comparing conventional anticoagulant treatment with dabigatran published between 2014 and 2020. In their results, they focused primarily on the safety of dabigatran. A total of 7 randomized studies including 10,743 patients were included in the systematic review.
Findings
Dabigatran was administered in these studies at doses of 110 or 150 mg twice a day, or 220 mg once daily. It was compared with placebo, acetylsalicylic acid, enoxaparin, warfarin, and rivaroxaban.
Compared to control groups, dabigatran was not associated with an increased risk of severe bleeding (relative risk [RR] 0.86; 95% confidence interval [CI] 0.61–1.21; p = 0.06), intracranial bleeding (RR 0.89; 95% CI 0.58–1.36; p = 0.41), fatal adverse events (RR 0.87; 95% CI 0.65–1.17; p = 0.66) or all-cause mortality (RR 0.88; 95% CI 0.70–1.11; p = 0.45). It also significantly reduced the risk of clinically relevant non-severe bleeding (RR 0.96; 95% CI 0.65–1.42; p = 0.0007).
Dabigatran was associated with an increased risk of gastrointestinal (GI) bleeding (RR 1.78; 95% CI 1.02–3.13; p = 0.05). The rate of GI bleeding was 2.4% in the dabigatran group and 1.3% in the control group.
Conclusion
The results of this meta-analysis suggest that dabigatran has a similar or even lower risk of bleeding compared to other anticoagulants. Its safety needs to be further studied to clarify the incidence of adverse events, but the studies indicate that it has a favorable safety profile concerning severe bleeding, intracranial bleeding, and life-threatening events. Dabigatran can be a suitable orally-administered alternative to vitamin K antagonists. Due to the short half-life of the drug, its administration can be altered or paused based on the patient’s needs and bleeding parameters.
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Source: Zhou Y., Yao Z., Zhu L. et al. Safety of dabigatran as an anticoagulant: a systematic review and meta-analysis. Front Pharmacol 2021 Feb 2; 12: 626063, doi: 10.3389/fphar.2021.626063.
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