This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database.
CADTH. Dabigatran for stroke prevention in atrial fibrillation: a review of the evidence on safety. Ottawa: Canadian Agency for Drugs and Technologies in Health (CADTH). 2012
Bleeding is typically the main safety issue of concern with all anticoagulants, including dabigatran. In RE-LY, the major randomized controlled trial (RCT) comparing dabigatran with warfarin, the risk of severe bleeding was reduced with the lower 110-mg dose of dabigatran compared with adjusted-dose warfarin, but there was no such reduction with the higher, 150-mg dose. However, there was evidence that in elderly patients there was no reduction in severe bleeding risk at either dose versus warfarin, and in the post-marketing period there was some evidence from case reports that elderly patients and/or those with severe renal impairment are at risk for serious bleeding events.
Subject indexing assigned by CRD
Anticoagulants; Atrial Fibrillation; Benzimidazoles; Pyridines; Strokes
Country of organisation
An English language summary is available.
Address for correspondence
Canadian Agency for Drugs and Technologies in Health (CADTH), 865 Carling Avenue, Suite 600, K1S 5S8 Ottawa, Ontario Canada Email: firstname.lastname@example.org
Date abstract record published