Authors' objectives:

To summarize the available information on ximelagatran (Exanta(TM) from AstraZeneca) for use in the treatment of venous thromboembolism (VTE), the prophylaxis of VTE in orthopedic surgery, the prophylaxis of stroke in patients with atrial fibrillation, and secondary prophylaxis in patients post-myocardial infarction.

Authors' results and conclusions: Several clinical trials have been undertaken to investigate the efficacy of ximelagatran in a variety of clinical situations (see objectives above). Few phase II and phase III trial results can be found in the published literature.

Authors' recommendations: Ximelagatran is the first oral direct thrombin inhibitor to proceed to late stage clinical development; very little progress has been made in recent history in regard to oral anticoagulation. The clinical trial program underway with this medication is extensive, with research in VTE treatment and research furthest along; the amount of published data available is relatively small, although trials have been conducted in over 20,000 patients. Generalizing findings may be difficult as there are subtle differences in the way anticoagulation is currently practised in the European and North American trial settings. The effect of ximelagatran on bleeding complications rates and INR monitoring will likely be factors in assessing its overall cost-effectiveness versus standard care.

Authors' methods: Overview

Project Status: Completed

URL for project: https://www.ccohta.ca/

Year Published: 2003

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Canada

Organisation Name: Canadian Coordinating Office for Health Technology Assessment

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 Coordinating Office for Health Technology Assessment (CCOHTA)