Brigham and Women’s Hospital in Boston, U.S., and Boehringer Ingelheim announce the results of a new interim analysis from a long-term study evaluating the safety and effectiveness of Pradaxa® (dabigatran etexilate) relative to warfarin in routine clinical practice.1 These data, from a pooled analysis of two large U.S. commercial health insurance databases, showed that patients with non-valvular atrial fibrillation (AF) treated with Pradaxa® had fewer strokes and fewer major bleeding events compared to AF patients treated with warfarin. 1 The findings were presented at the American Heart Association (AHA) Scientific Sessions 2015 in Orlando.
“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, PharmD, DrPH, 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 AF 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 programme, in collaboration with Brigham and Women’s Hospital, we are seeking to expand awareness and understanding of real-world experiences with non-vitamin K antagonist oral anticoagulants (NOACs) and the impact on reducing stroke risk, which remains a major public health concern,” said Professor Jörg Kreuzer, Vice President Medicine, Therapeutic Area Cardiovascular, Boehringer Ingelheim. “These data add to the robust world of evidence supporting the real-world value of Pradaxa®, the only NOAC with both proven superiority to warfarin in reducing stroke risk in AF patients and a specific reversal agent.”