Study Compares Safety, Efficacy of Pradaxa vs. Warfarin for Reducing Stroke, Major Bleeding Risk

Brigham and Women's Hospital and Boehringer Ingelheim announced the results of a new interim analysis from a long-term study showing that patients with non-valvular atrial fibrillation (AF) treated with Pradaxa (dabigatran) had fewer strokes and major bleeding events compared to AF patients treated with warfarin. These findings were presented at the American Heart Association (AHA) Scientific Sessions 2015 in Orlando, Florida.

The new findings were based on data from a pooled analysis of two large U.S. commercial health insurance databases, Truven MarketScan and Optum Clinformatics, collected over 32 months in 44,672 AF patients. The primary study outcomes were stroke and major bleeding rates during Pradaxa and warfarin treatment.

Researchers found a 28% reduction in stroke risk for Pradaxa compared to warfarin (HR 0.72; 95% CI: 0.52–1.00), identifying 65 strokes in Pradaxa-treated patients (0.73 incidence rate per 100 patient years) vs. 78 strokes in warfarin-treated patients (1.08 incidence rate per 100 patient years). They also found a 26% reduction in the risk of major bleeding events with Pradaxa compared to warfarin (HR 0.74; 95% CI: 0.64–0.84), 395 (4.47 incidence rate per 100 patient years) vs. 459 (6.42 incidence rate per 100 patient years) events, respectively. Among the major bleeding events found, Pradaxa had 238 with gastrointestinal etiology (2.69 incidence rate per 100 patient years) while warfarin had 213 ((2.97 incidence rate per 100 patient years); HR 0.95; 95% CI: 0.79–1.14).

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