The direct thrombin inhibitor ximelagatran/melagatran: A systematic review on clinical applications and an evidence based assessment of risk benefit profile

Luca Testa, Ravinai Bhindi, Pierfrancesco Agostoni, Antonio Abbate, Guiseppe G L Biondi Zoccai, William J. Van Gaal

Research output: Contribution to journalArticle

Abstract

The direct thrombin inhibitor, ximelagatran, and its active form, melagatran (X/M), have been compared against conventional anticoagulant therapy (CAT) in many clinical settings. Their risk-benefit profile drove large debate until withdrawal by the manufacturer. A systematic review of all published randomized trials has been performed and a meta-analysis of randomised controlled trial (RCT) of X/M versus CAT. Major medical databases were searched for RCTs. Major adverse events (MAE: all cause death, nonfatal myocardial infarction, nonfatal thromboembolic stroke, pulmonary embolism), major bleeds (MB), minor bleeds and the rate of hepatotoxicity (HT) were compared. In terms of efficacy, X/M was at least as effective as, or even superior to, CAT. In terms of safety, the overall risk of MAE, MB, minor bleeds and HT was not significantly different for X/M compared with CAT. According to individual clinical settings, X/M was associated with a lower risk of MB but a prohibitive higher risk of HT in those clinical settings requiring prolonged treatment.

Original languageEnglish
Pages (from-to)397-406
Number of pages10
JournalExpert Opinion on Drug Safety
Volume6
Issue number4
DOIs
Publication statusPublished - Jul 2007

Keywords

  • Anticoagulants
  • Melagatran
  • Meta-analysis
  • Thrombosis
  • Ximelagatran

ASJC Scopus subject areas

  • Pharmacology

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