MIGHT XIMELAGATRAN REPLACE WARFARIN IN PATIENTS WITH NONVALVULAR AFIB?

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MIGHT XIMELAGATRAN REPLACE WARFARIN IN PATIENTS WITH NONVALVULAR AFIB?

In patients with nonvalvular atrial fibrillation (NVAF), warfarin anticoagulation limits stroke risk better than aspirin does. Ximelagatran is a new, oral direct thrombin inhibitor (DTI) with consistent pharmacokinetic properties that obviate the needs for dose titration and routine coagulation monitoring that are characteristic of warfarin use. In this European, 12-week safety study, funded by ximelagatran's manufacturer, 254 patients with persistent, verified NVAF and at least 1 stroke risk factor were randomized to 1 of 3 twice-daily doses of ximelagatran (20, 40, or 60 mg) or to dose-adjusted warfarin (target INR, 2.0-3.0).

Adherence to ximelagatran was at least 96% for all 3 doses. No subject suffered a systemic embolic event. Major bleeding occurred in no ximelagatran recipients and in 1 warfarin recipient. The minor-bleeding rate ranged from 6% to 12% in the ximelagatran groups and was 9% in the warfarin group. Rates of overall adverse events were similar with ximelagatran and warfarin, as were drug-discontinuation rates. Transient liver-enzyme abnormalities were noted in 4% of ximelagatran recipients and in no warfarin recipients. Therapeutic INRs were achieved in 57% of warfarin recipients by 12 weeks.

Comment: This study reveals that warfarin and the new, oral DTI ximelagatran have similar safety profiles in patients with NVAF. As in other studies, a low percentage of warfarin recipients achieved therapeutic INRs, emphasizing the need for better anticoagulants. If large clinical trials show that ximelagatran is as good as or better than warfarin for preventing systemic emboli in NVAF, this DTI, once FDA-approved, likely would replace warfarin for this indication.

— Howard C. Herrmann, MD

Published in Journal Watch Cardiology January 2, 2004

Citation(s):

Petersen P et al. for the SPORTIF II Investigators. Ximelagatran versus warfarin for stroke prevention in patients with nonvalvular atrial fibrillation. SPORTIF II: A dose-guiding, tolerability, and safety study. J Am Coll Cardiol 2003 May 7; 41:1445-51.

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