Dabigatran for stroke prevention in atrial fibrillation: a review of the evidence on safety
CADTH
Record ID 32012000661
English
Authors' recommendations:
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.
Details
Project Status:
Completed
Year Published:
2012
URL for published report:
http://www.cadth.ca/media/pdf/htis/mar-2012/RC0332%20Dabigatran%20update%20Final.pdf
English language abstract:
An English language summary is available
Publication Type:
Not Assigned
Country:
Canada
MeSH Terms
- Atrial Fibrillation
- Benzimidazoles
- Pyridines
- Anticoagulants
Contact
Organisation Name:
Canadian Agency for Drugs and Technologies in Health
Contact Address:
600-865 Carling Avenue, Ottawa, ON K1S 5S8 Canada. Tel: +1 613 226 2553; Fax: +1 613 226 5392;
Contact Name:
requests@cadth.ca
Contact Email:
requests@cadth.ca
Copyright:
Canadian Agency for Drugs and Technologies in Health (CADTH)
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.