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Published on: October 12, 2012
Pharmacodynamic evaluation of warfarin and rosuvastatin co-administration in healthy subjects
Daisy Jindal1, Monika Tandon, Sanjay Sharma
1Apollo Hospital, New Delhi, India. jindal_daisy@yahoo.com
Objective:
To determine whether co-administration of rosuvastatin alters the pharmacodynamics of warfarin, thereby requiring additional monitoring of the anticoagulant effects of warfarin.
Methods:
In this open-labeled, placebo-controlled, randomized, two-period, crossover trial with a washout period of 15 days, 12 healthy male volunteers were administered daily oral doses of 5 mg warfarin for 14 days. Either rosuvastatin 40 mg/day (treatment A) or placebo (treatment B) was concomitantly administered on days 8-14. The pharmacodynamic parameters prothrombin time (PT) and international normalized ratio (INR) were evaluated on all 14 days pre-dose during both study periods. On the 8th, 10th, 12th, and 14th days of each study period, PT and INR were also measured at 4 h post-dose of rosuvastatin or placebo. Bleeding time and clotting time were assessed on the 1st, 8th, and 14th days pre-dose.
Results:
Data of 10 subjects have been analyzed. No significant effect of rosuvastatin was seen on the steady-state pharmacodynamics of warfarin during concomitant administration.
Conclusion:
Rosuvastatin did not significantly alter the anticoagulant effects of warfarin in this study.
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