Authors' objectives: The purpose of this report is to assess the evidence available on the efficacy, safety and issues related to coverage policies on the use of dabigatran for the prevention of ischemic stroke (IS) in patients with acute or chronic atrial fibrillation (AF).

Authors' recommendations: In the only randomized clinical trial, dabigatran 150mg bid is slightly better than warfarin in preventing IS, embolic events and vascular death and 100mg big is non inferior to warfarin, with no significant increase in major bleeding. It is worth mentioning that this was an open-label study, with just two-year follow up. The applicability of results is uncertain due to inadequate INR control in some countries. Quality of life in these patients, which is a primary reason for cost-effectiveness studies, was not assessed in the study. The use of dabigatran in patients with AF as an alternative to vitamin K antagonists (VKA) might be specially considered when: Patients receiving VKA therapy present unstable INR, when there is increased risk of drug and food interactions and in those who are warfarin-hypersensitive. In AF patients receiving VKA and who have adequate INR control, dabigatran might be an alternative, its comfort and higher cost should be taken into account. In patients at risk of increased bleeding, its use might be considered at 110mg doses bid, since it is as efficient as VKA but presents lower risk of bleeding.

Project Status: Completed

Year Published: 2011

URL for published report: https://www.iecs.org.ar/home-ets/?cod_publicacion=1323&origen_publicacion=publicaciones

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Argentina

Organisation Name: Institute for Clinical Effectiveness and Health Policy

Contact Address: Dr. Emilio Ravignani 2024, Buenos Aires - Argentina, C1414 CABA

Contact Name: info@iecs.org.ar

Contact Email: info@iecs.org.ar

Copyright: Institute for Clinical Effectiveness and Health Policy (IECS)