Results of GlaxoSmithKline trial indicate Arixtra prevents venous thromboembolism

By Lisa Kerner

Erie, Pa., Feb. 3 - GlaxoSmithKline said results from a new study of Arixtra (fondaparinux sodium) showed the anti-thrombotic drug was generally well tolerated and effective in the prevention of symptomatic venous thromboembolism (VTE) when administered to patients the morning after orthopedic surgery.

Venous thromboembolism is a common complication of total knee or hip replacement surgery, according to a company news release.

The study, known as Flextra (Flexibility in Administration of Fondaparinux for Prevention of Symptomatic Venous Thromboembolism in Orthopaedic Surgery), was published in the January issue of The Journal of Arthroplasty.

Flextra evaluated the tolerability and efficacy of Arixtra following total joint arthroplasty. Study results demonstrated that delayed initiation of Arixtra prophylaxis may provide an alternative dosage regimen for preventing VTE after total joint arthroplasty.

"Many factors, such as patient status and a hospital's routine dosing schedule, can delay the administration of anti-thrombotics," lead author Clifford W. Colwell Jr., MD, said in the release.

"These results showed that administration of Arixtra the morning after surgery was just as effective in decreasing the risk of symptomatic VTE as administered 6 to 10 hours post-operation the day of surgery."

The primary endpoint of the study was the comparison of tolerability and efficacy of Arixtra (2.5 mg) in patients using two different dosing schedules. The study included 2,046 patients, 2,000 of whom were evaluated for efficacy. Both groups were similar for baseline, surgical, and post-surgical characteristics. Safety results, including low risk of bleeding, were similarly low for both groups.

GlaxoSmithKline is a research-based pharmaceutical and health care company based in London.

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