Ximelagatran monitoring not needed in deep vein thrombosis

Last Updated: 2005-04-25 15:06:13 -0400 (Reuters Health)

NEW YORK (Reuters Health) - When given to patients with acute deep vein thrombosis, the pharmacokinetics of melagatran, the active form of ximelagatran, are predictable and the exposure-response curves suggest that individualized dosing and monitoring of the parent drug is not needed.

The findings, which appear in the April issue of Clinical Pharmacology & Therapeutics, are based on analysis of drug levels in 264 patients with acute deep vein thrombosis. The subjects were treated with ximelagatran at a dose of 24, 36, 48, or 60 mg twice daily for 12 to 16 days and total of 1836 blood samples were available for analysis.

Creatine clearance, volume of distribution, and body weight all correlated with drug clearance after oral administration, lead author Marie Cullberg, from AstraZeneca R&D in Molndal, Sweden, and colleagues note.

By contrast, gender, age, and smoking status had no effect on the pharmacokinetics of melagatran after accounting for body weight and renal function, the investigators point out.

The estimated exposure-response curves for efficacy and bleeding were relatively flat, suggesting that ximelagatran need not be tailored to a particular patient or monitored, the researchers conclude.

Clin Pharmacol Ther 2005;77:279-290.

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