P286Safety and effectiveness of dabigatran relative to warfarin in routine care: final results from a long-term monitoring program

Le résumé fourni par la source

Introduction: Randomized controlled trials (RCTs) are considered the gold-standard study design and form the basis for approval of prescription drugs. However, RCTs often include a selected study population and may not be reflective of routine care Purpose: To demonstrate the utility of a continuous long-term monitoring program to study the safety and effectiveness of dabigatran compared to warfarin in routine care after its US market approval in October 2010 using 2 US healthcare insurance claims databases (MarketScan and Clinformatics) in patients with non-valvular atrial fibrillation Methods: We implemented a cohort design with propensity score (PS) matching to compare initiators of dabigatran and warfarin between October 2010 and September 2015. The first analysis covered the interval October 2010- December 2012 with subsequent analyses covering 6-month intervals accumulating additional data each time. We used proportional hazards regression to monitor the primary outcomes of hospitalization for hemorrhagic and ischemic stroke, and hospitalization for major bleeding (intracranial and extracranial bleeding). Patients were followed until switch or discontinuation of the anticoagulant, occurrence of an outcome event, or disenrollment. Numerous subgroup and sensitivity analyses were conducted to test the robustness of the findings, including a high-dimensional PS (hdPS) analysis to account for empirically identified proxies of unmeasured confounders

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.