Efficacy and safety of bemiparin compared with enoxaparin: Meta-analysis of randomized controlled trials.

Background: Potential advantages of bemiparin compared to enoxaparin are a longer half-life, once-a-day dosage, and possibly a better safety profile due to the more selective antagonistic action toward Xa coagulation factor. We evaluated the efficacy and safety of bemiparin compared with enoxaparin as prophylaxis or treatment of venous thromboembolic disease.

Materials And Methods: We searched PubMed, Embase, Cochrane Library, Clinical Trials.gov, Google academics, and Conference Abstracts (2014 - 2019) of the American Society of Hematology and the Spanish Society of Hematology and Hemotherapy. Randomized trials that included bemiparin and enoxaparin were included as treatment arms. The outcomes evaluated were the incidence of venous thromboembolic disease and the proportion of adverse events in each group. Two independent researchers selected, evaluated, and extracted the data in duplicate. Four studies with a total of 5,473 patients were included.

Results: Most patients were included in prevention studies (N = 5,161). Bemiparin proved the non-inferiority in terms of efficacy with respect to enoxaparin (relative risk: 0.76; 95% confidence interval (95% CI): 0.56 - 1.01; p = 0.06) (heterogeneity I = 34%). We recorded 222 adverse events in 2,742 patients treated with bemiparin and 288 adverse events in 2,731 patients treated with enoxaparin (8.1 vs. 10.5 adverse events per 100 patients, respectively; p = 0.003). However, the meta-analysis for safety showed a significant heterogeneity making not possible to pool the result across the trials.

Conclusion: Bemiparin proved a non-inferior efficacy compared to enoxaparin with a significant reduction in adverse events per 100 patients treated.