Dabigatran for stroke prevention in nonvalvular atrial fibrillation: answers to challenging "real-world" questions.

Jorge Ferreira,Paulo Bettencourt,Miguel Viana-Baptista,Rui Cernadas,Daniel Ferreira,Francisco Crespo

doi:10.1155/2012/867121

Abstract

Dabigatran etexilate is a novel, oral, reversible, direct thrombin inhibitor that constitutes a major breakthrough for stroke prevention in patients with nonvalvular atrial fibrillation (AF). Dabigatran was the first new oral anticoagulant approved in Europe and became available in Portugal, for stroke prevention in nonvalvular AF, earlier than in most European countries. This paper is the joint effort of a panel of experts from different specialties and provides information on the use of dabigatran, in anticipation of the challenges that will come with increased usage.

Highlights

Dabigatran etexilate and other new oral anticoagulants (OACs) constitute a major breakthrough for stroke prevention in patients with nonvalvular atrial fibrillation (AF)
Dabigatran (Pradaxa, Boehringer Ingelheim, Ingelheim, Germany) is a reversible direct thrombin inhibitor and, in the RE-LY trial (Randomized Evaluation of Long-term anticoagulation therapY), a phase III study, 150 mg bid was more effective in terms of stroke prevention in nonvalvular AF than vitamin K antagonists (VKAs), whereas 110 mg bid was as effective as VKA, with a lower risk of bleeding [1]
The European Medicines Agency approved the doses of 150 mg bid and 110 mg bid [3] as an alternative to warfarin for stroke and systemic embolism (SE) reduction in patients with nonvalvular AF

Summary

Introduction

Dabigatran etexilate (designated as dabigatran from here onwards) and other new oral anticoagulants (OACs) constitute a major breakthrough for stroke prevention in patients with nonvalvular atrial fibrillation (AF). They have been shown to be an alternative to vitamin K antagonists (VKAs) that does not require routine laboratory control. There is no definite explanation for these facts, but a recent survey suggested that a higher prevalence of AF in the Portuguese population aged 40 and over, as compared to studies carried out in other countries, combined with an underutilization of VKAs, might contribute to these figures [10,11,12]. Given the lack of specific clinical evidence, some of the recommendations below are based exclusively on the opinion of the authors and are identified as Author’s Recommendations (AR)

Questions

Findings

Conclusion