Real-world analysis of more than 44,000 patients reinforces safety and effectiveness of Pradaxa in routine clinical care

New data show Pradaxa reduced stroke risk and major bleeding compared to warfarin in patients with non-valvular atrial fibrillation.

"Beyond clinical trials, there is a wealth of available health insurance data that provides an excellent opportunity to grow our knowledge of oral anticoagulant use and outcomes for patients," said lead investigator John Seeger, Department of Medicine, Brigham and Women's Hospital, a teaching-affiliate of Harvard Medical School. "These real-world data further define the safety and effectiveness of dabigatran for patients and its use in routine care, and are consistent with the results of the pivotal RE-LY clinical trial."

The primary study outcomes were stroke and major bleeding rates during PRADAXA and warfarin treatment, based on data collected over 32 months from 44,672 NVAF patients (22,336 propensity score matched Pradaxa and warfarin treatment initiators) in two insurance databases — Truven MarketScan (18,276 patients per group) and Optum Clinformatics (4,060 patients per group). Researchers identified 65 strokes for Pradaxa-treated patients (0.73 incidence rate per 100 patient years) and 78 strokes for warfarin-treated patients (1.08 incidence rate per 100 patient years), representing a 28% reduction in stroke risk for Pradaxa compared to warfarin (HR 0.72; 95% CI 0.52 - 1.00). In addition, researchers reported 395 major bleeding events for Pradaxa-treated patients (4.47 incidence rate per 100 patient years), compared to 459 events for warfarin-treated patients (6.42 incidence rate per 100 patient years), representing a 26% reduction in the risk of major bleeding events with Pradaxa compared to warfarin (HR 0.74; 95% CI 0.64 - 0.84). There were 238 major gastrointestinal bleeding events for Pradaxa-treated patients (2.69 incidence rate per 100 patient years) and 213 for warfarin treated patients ((2.97 incidence rate per 100 patient years); HR 0.95; 95% CI 0.79 - 1.14).

"With this long-term study program, in collaboration with Brigham and Women's Hospital, we are seeking to expand awareness and understanding of real-world experiences with NOACs and the impact on reducing stroke risk, which remains a major public health concern," said Sabine Luik, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim. "These data add to the robust research program supporting the real-world value of Pradaxa, the only NOAC with both proven superiority to warfarin in reducing stroke risk in NVAF patients and a specific reversal agent."