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NEW DRUG DEVELOPMENTS

Ximelagatran: An Oral Direct Thrombin Inhibitor

Pharmacist Specialist, Department of Pharmaceutical Services, University of California Davis Medical Center, Sacramento, CA; Clinical Professor of Pharmacy, School of Pharmacy, University of California at San Francisco; Associate Clinical Professor of Medicine, University of California Davis School of Medicine

Thomas G Vondracek, PharmD BCPS

Clinical Pharmacy Specialist, Exempla Saint Joseph Hospital, Denver, CO

Bruce A McIntosh, PharmD

Assistant Professor, Department of Pharmacy Practice, University of Kentucky, Lexington, KY; Clinical Specialist, Pharmacy Services, Department of Veterans Affairs Medical Center, Lexington

Edith A Nutescu, PharmD

Clinical Assistant Professor; Director, Antithrombosis Service, College of Pharmacy, University of Illinois at Chicago, Chicago, IL

Reprints: William E Dager PharmD FCSHP, Department of Pharmaceutical Services, University of California Davis Medical Center, 2315 Stockton Blvd., Sacramento, CA 95817-2201, fax 916/703-4031, william.dager{at}ucdmc.ucdavis.edu

OBJECTIVE: To present the chemistry, pharmacology, and pharmacokinetics of ximelagatran, an oral direct thrombin inhibitor (DTI), and to review available comparative clinical trial data evaluating its efficacy and safety relative to other antithrombotic agents in the prevention and treatment of thromboembolism.

DATA SOURCES: A search of the PubMed and Cochrane databases (1995–August 2004), supplemented by a manual search of article bibliographies, conference abstracts, and data on file from the manufacturer, was conducted. Key search terms were ximelagatran, melagatran, H376/95, and direct thrombin inhibitors.

STUDY SELECTION AND DATA EXTRACTION: Pertinent information from available clinical trials, including study design, patient demographics, dosing regimens, anticoagulant comparators, methods for evaluating effectiveness, treatment outcomes, adverse events, and pharmacokinetic and pharmacodynamic evaluations, was extracted.

DATA SYNTHESIS: Ximelagatran is an orally administered DTI under development for use in the treatment of venous thromboembolism (VTE), long-term prevention of a second VTE event, stroke secondary to atrial fibrillation, prevention of VTE after orthopedic procedures, and recurrent ischemic events after acute myocardial infarction.

CONCLUSIONS: Ximelagatran, in twice-daily doses of 24 or 36 mg, is an alternative to low-molecular-weight heparins or warfarin in thromboprophylaxis following orthopedic knee replacement, atrial fibrillation, or initial treatment of VTE. Improved outcomes versus placebo were seen in the long-term prevention of VTE in patients who completed an initial 6 months of treatment. Liver-related effects need further clarification.

Key Words: anticoagulants, atrial fibrillation, deep vein thrombosis, direct thrombin inhibitors, melagatran, thromboembolism, ximelagatran

Published Online, September 21, 2004. www.theannals.com, DOI 10.1345/aph.1E078

THIS ARTICLE IS APPROVED FOR CONTINUING EDUCATION CREDIT
ACPE UNIVERSAL PROGRAM NUMBER: 407-000-04-033-H01

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				A. Lazo-Langner, M. A. Rodger, and P. S. Wells Lessons From Ximelagatran: Issues for Future Studies Evaluating New Oral Direct Thrombin Inhibitors for Venous Thromboembolism Prophylaxis in Orthopedic Surgery Clinical and Applied Thrombosis/Hemostasis, June 1, 2009; 15(3): 316 - 326. [Abstract] [PDF]

				M. P. Gulseth Ximelagatran: An orally active direct thrombin inhibitor Am. J. Health Syst. Pharm., July 15, 2005; 62(14): 1451 - 1467. [Abstract] [Full Text] [PDF]