In everyday, routine clinical practice, the direct thrombin inhibitor dabigatran etexilate and warfarin are associated with similar incidences of bleeding complications and systemic embolism, according to a study published on March 26 in the Journal of the American College of Cardiology.

The study also found that dabigatran was associated with lower rates of death, intracranial hemorrhage and other thromboembolic events.

The study used data from the Danish Registry of Medicinal Product Statistics, and compared 4,978 patients with atrial fibrillation treated with dabigatran (110 or 150 mg) and 8,936 propensity-matched patients treated with warfarin. Results showed that there was no difference between treatments in the incidence of stroke and systemic embolism. However, adjusted mortality was significantly lower with both dabigatran doses (110mg BID: propensity match group stratified HR (aHR): 0.79, 95 percent CI: 0.65-0.95, 150mg BID: aHR: 0.57, 95 percent CI: 0.40-0.80), when compared to warfarin. Pulmonary embolism was lower compared to warfarin for both doses of dabigatran.

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Further, less intracranial bleeding was seen with both dabigatran doses (110mg BID: aHR: 0.24 95 percent CI: 0.08-0.56, 150mg BID: aHR: 0.08, 95 percent CI: 0.01-0.40), and the incidence of myocardial infarction was lower with both dabigatran doses (110mg BID, aHR: 0.30, 95 percent CI: 0.18-0.49; 150mg BID, aHR: 0.40, 95 percent CI: 0.21-0.70). Gastrointestinal bleeding was also lower with dabigatran 110mg BID (aHR: 0.60, 95 percent CI: 0.37-0.93) compared to warfarin, but not dabigatran 150mg BID. These results were consistent among patients with more than one year's follow-up (median follow-up 13.9 months (IQR: 12.6-15.3)).

"In conclusion, efficacy in terms of stroke and systemic embolism prevention was similar between warfarin and dabigatran (both doses), whereas mortality, pulmonary embolism and MI were lower with both doses of dabigatran in this 'everyday clinical practice' post-approval clinical cohort. Regarding safety, major bleeding was similar between dabigatran and warfarin, whilst intracranial bleeding was lower with both dabigatran doses," concluded the investigators. "The previous concerns about an excess of bleeding events or MI amongst dabigatran treated-patients were not evident."

Keywords: Myocardial Infarction, Stroke, Thrombin, Pulmonary Embolism, Warfarin, Pyridines, Registries, Incidence, Intracranial Hemorrhages, beta-Alanine, Benzimidazoles, Embolism, United States

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