Authors' objectives:

To summarise the current research evidence on the effectiveness of melagatran and H376/95 in venous thromboembolism.

Authors' recommendations: Melagatran (subcutaneous) and H376/95 (oral) are thrombin inhibitors in phase III trials for the prevention of venous thromboembolism (VTE) and in phase II/III trials for the treatment of VTE and the prevention of stroke in people with atrial fibrillation. Neither melagatran nor H376/95 regular laboratory monitoring of anticoagulant effect. - Clinical impact: Melagatran and H376/95 may be indicated for use in a very large patient group. The ability to interchange the injectable and oral forms of the drug provides significant greater flexibility in the management of DVT. Without the need for careful monitoring, melagatran and/or H376/95 has the ability to directly compete with current treatments such as warfarin. - Service impact: There may be potential savings in hospital care and laboratory services using these products for the prevention and treatment of VTE. The decrease in monitoring and ease of transfer to oral therapy should allow a shorter hospital stay after surgery or after initial stabilisation of DVT. The lack of regular monitoring may potentially increase the proportion of people willing to undertake anticoagulation. Additionally, clinicians may be more willing to offer more patients anticoagulant treatment because of the current concerns about adverse effects of warfarin therapy. - Patient issues: Melagatran and H376/95 may be preferred by patients because of the absence of severe adverse effects and restrictions on lifestyle, its ability to be taken orally and the reduced need for monitoring. - Financial and overall NHS impact: As there is no cost data available it is difficult to predict the financial impact of this new drug but it may be large particularly if oral H376/95 directly competes with warfarin in primary care.

Authors' methods: Overview

Project Status: Completed

Year Published: 2001

URL for published report: http://www.hsric.nihr.ac.uk/search

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Horizon Scanning Centre

Contact Address: The NIHR Horizon Scanning Centre, Department of Public Health, Epidemiology, and Biostatistics, School of Health and Population Sciences, University of Birmingham, 90 Vincent Drive, Edgbaston, Birmingham, B15 2SP. United Kingdom. Tel: +44 121 414 7831, Fax: +44 121 2269

Contact Name: c.packer@bham.ac.uk

Contact Email: c.packer@bham.ac.uk

Copyright: National Horizon Scanning Centre