Abstract | AIM: The efficacy and safety of the new oral, direct and selective thrombin inhibitor Ximelagatran and its active form Melagatran was analysed in patients undergoing total hip or knee replacement. METHODS AND PATIENTS: Methro II, a randomised, double-blind controlled dose-finding study, involved 1876 patients. Melagatran (1, 1.5, 2.25 or 3 mg; twice daily; start: immediately before surgery) was given subcutaneously, followed by orally administered Ximelagatran (8, 12, 18 or 24 mg, twice daily, day after surgery) and compared to subcutaneously administered dalteparin (5000 IE, once daily). Methro III was a randomised, double blind controlled study involving 2788 patients. The fixed dose of 3 mg Melagatran was given (start: 4-12 hours postoperatively) followed by oral Ximelagatran (24 mg, twice daily, day after surgery) compared to subcutaneous enoxaparin (40 mg, once daily). In both studies, dalteparin or enoxaparin was applied at the evening before operation; the treatment lasted 8 to 11 days. A bilateral venography was performed at the last day of treatment. RESULTS: CONCLUSIONS:
|
Authors | P Mouret |
Journal | Hamostaseologie
(Hamostaseologie)
Vol. 22
Issue 3
Pg. 21-4
(Aug 2002)
ISSN: 0720-9355 [Print] Germany |
Vernacular Title | Der orale direkte Thrombininhibitor Ximelagatran. |
PMID | 12215757
(Publication Type: Clinical Trial, English Abstract, Journal Article, Multicenter Study, Randomized Controlled Trial)
|
Chemical References |
- Antithrombins
- Azetidines
- Benzylamines
- Prodrugs
- ximelagatran
|
Topics |
- Administration, Oral
- Antithrombins
(administration & dosage, therapeutic use)
- Arthroplasty, Replacement, Hip
(adverse effects)
- Arthroplasty, Replacement, Knee
(adverse effects)
- Azetidines
(administration & dosage, therapeutic use)
- Benzylamines
- Double-Blind Method
- Humans
- Postoperative Complications
(prevention & control)
- Prodrugs
(administration & dosage, therapeutic use)
- Thromboembolism
(prevention & control)
|