SLR - April 2010 - Priya Parthasarathy
Reference:
Baanstra,D.,Eriksson,H.,Goldhaber,Z.,Kakkar,A., et al. (2009). Dibagatran versus Warfarin in the Treatment of Acute Venous Thromboembolism. The New England Journal of Medicine, 361, 2342-2352
Scientific Literature Review
Reviewed by: Priya Parthasarathy, DPM
Residency Program: Botsford Hospital
Podiatric Relevance
Venous thromboembolism is a common but underdiagnosed medical condition. The epidemiologic features, economic impact, morbidity, and mortality of venous thromboembolism make it imperative that the podiatric physician be familiar with its pathogenesis as well as any advances in its pharmacologic treatment.
Methods
This study design consisted of 2564 patients randomized into adouble-blind, noninferiority trial. Patients were recruited from 228 clinical centers in 29 countries with a mean age of 55. All patients had an acute venous thromboembolism and were initially given parenteral anticoagulation therapy for a median of 9 days. Oral dabigratran administered at a dose of 150 mg daily was compared to warfarin that was dosed to achieve an international normalized ratio of 2.0-3.0 for 6 months. The primary outcome was the 6 month incidence of recurrent symptomatic, objectively confirmed venous thromboembolism and related deaths.
Results
27 of the 1265 patients randomly assigned to warfarin (2.1%) and 30 of the 1274 patients randomly assigned to receive dabigatrain (2.4%) had recurrent venous thromboembolism. Major bleeding episodes occurred in 24 patients assigned to warfarin (1.9%) and in 20 patients assigned to dabigatrain (1.6%). The number of acute coronary syndromes, abnormal liver function tests, and deaths were similar in the 2 groups. Adverse events which lead to the discontinuation of the study drug occurred in 6.8% of patients assigned to warfarin and 9.0% of patients assigned to dabigatran.
Conclusions
According to the study results, dabigatran at a fixed dose is as effective as warfarin, has a safety profile that is similar to warfarin, and does not require laboratory monitoring. However, the first dose of dabigatran was given only after initial parenteral anticoagulation therapy had been administered for a median of 9 days. Further studies further studies should be done to support the use of dabigatran monotherapy for acute venous thromboembolism.