Key result
Ximelagatran links to dose-dependent ALAT increases but less frequent ASAT elevations, indicating nontoxic liver effects.
Why the study?
Does ximelagatran affect ALAT and ASAT levels compared to enoxaparin/warfarin or placebo in patients with venous thromboembolism?
Population
75 patients in Germany treated for acute venous thromboembolism and prophylaxis of recurrent events
Comparison
Oral ximelagatran (2 x 36 mg or 2 x 24 mg) vs Enoxaparin/warfarin or placebo
Design
Cohort
Follow-up
6 months
Authors
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May warrant ALAT monitoring with ximelagatran; leaves open comparative hepatotoxicity versus enoxaparin/warfarin.
Cohort (n=75)
Does ximelagatran affect ALAT and ASAT levels compared to enoxaparin/warfarin or placebo in patients with venous thromboembolism?
Ximelagatran causes a dose-dependent increase in ALAT without a corresponding increase in ASAT, suggesting a non-toxic effect on liver cells.
Harenberg et al. (2006) conducted a cohort in acute venous thromboembolism (VTE) (n=75). Ximelagatran vs. Enoxaparin/warfarin or placebo was evaluated on Time course of ALAT and ASAT levels. Ximelagatran induced a dose-dependent increase in ALAT values at 3 and 6 months (p=0.0105 and p=0.0063 vs lower dose), with less frequent ASAT increases indicating a nontoxic effect on liver cells.
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