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Title: Ximelagatran Compares Well with Standard Therapy for Deep Vein Thrombosis: Presented at ASH

"Ximelagatran Compares Well with Standard Therapy for Deep Vein Thrombosis: Presented at ASH"

By Roberta Friedman, PhD SAN DIEGO, CA -- December 15, 2003 -- The oral thrombin blocker ximelagatran is as safe and effective as the standard treatment for preventing recurrence of symptomatic deep vein thrombosis (DVT), according to findings from the THRIVE study reported here December 7th at the American Society of Hematology 45th Annual Meeting. Study investigator Charles Francis MD, professor of medicine, University of Rochester, New York, said, "We think ximelagatran has potential in treating DVT, as an oral alternative to a cumbersome" standard regimen of heparins followed by warfarin. The downside to the treatment is a delayed and apparently spontaneously resolving elevation of liver enzymes. Dr. Francis noted that the low molecular weight heparin enoxaparin also elevates liver enzymes, but earlier, so the study may have missed some of these changes. Investigators for the THRIVE study (THRombin Inhibitor in Venous thromboEmbolism) randomized 2,489 patients to receive either ximelagatran alone or enoxaparin followed by warfarin. Patients had acute DVT with pulmonary embolism confirmed for 37%. Patients were randomized within 2 weeks of their symptoms onset. Half of patients had 6 months of treatment with the oral drug, dosed at 36 mg twice a day. The other half had heparin 1 mg/kg twice daily for 5 days followed by 6 months of warfarin targeted at an international normalized ratio of 2.0 to 3.0. Compression ultrasound of the legs and ventilation perfusion lung scan detected the presence of thrombi. Both treatments gave 2% risk of thrombosis recurrence. Rate of major bleeds did not statistically differ between the two groups. Ximelagatran therapy produced bleeding events in 1.3% of patients, compared to 2.2% of patients who were given standard treatment. The study showed that the oral agent "clearly met the non-inferiority margin" as being equivalent to the standard treatment for safety and efficacy, said Dr. Francis. Serum glutamic pyruvic transaminase (ALT) levels increased in 9.6% of patients taking ximelagatran, and in 2% of those on standard therapy. "It does take a while" for the elevated enzyme to return to normal after ximelagatran therapy, said Dr. Francis, adding that "we will see what the regulatory agencies say" about the changes in this index of liver function. "I'm not particularly concerned" about the enzyme change, he added. AstraZeneca sponsored the study. [Study title: Efficacy and Safety of the Oral Direct Thrombin Inhibitor Ximelagatran Compared with Current Standard Therapy for Acute, Symptomatic Deep Vein Thrombosis, with or without Pulmonary Embolism: The THRIVE Treatment Study. Abstract 7]

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