GlaxoSmithKline reports pivotal study shows reduced risk of venous thromboembolism

By Lisa Kerner

Erie, Pa., Feb. 13 - GlaxoSmithKline said results from the Artemis study of Arixtra (fondaparinux sodium) evaluating the overall efficacy and safety of Arixtra in older acutely medically ill patients demonstrated that treatment with the antithrombotic reduced patients' risk of overall venous thromboembolish by 46.7% with no increased risk of major bleeds compared with a placebo.

Venous thromboembolism is a disease state comprising deep vein thrombosis and pulmonary embolism, according to a company news release.

Arixtra selectively inhibits Factor Xa, a central protein in the coagulation process.

The double-blind, randomized, placebo-controlled trial included 849 patients (at least 60 years old) in 35 sites across 8 countries. Patients were admitted to hospital for congestive heart failure, acute respiratory disease, acute infections or inflammatory disease and were expected to remain in bed for at least four days.

The patients were randomized to receive Arixtra 2.5 mg or a placebo once daily of subcutaneous injections for 6 to 14 days.

The primary efficacy outcome was deep vein thrombosis detected by routine bilateral venography along with symptomatic deep vein thrombosis and fatal and non fatal pulmonary embolism up to day 15.

Results showed that venous thromboembolism was detected in 5.6% of patients treated with Arixtra versus 10.5% of patients on a placebo.

The Artemis study was published in the Feb. 11 issue of the British Medical Journal.

"[Venous thromboembolism] presents a significant risk to this patient population, however we have had limited understanding of the effectiveness of clot prevention to address [venous thromboembolism] in this group," Alexander Cohen, chairman of the steering committee of the Artemis study, said in the release.

"These results show that Arixtra is an effective and well tolerated treatment that can reduce the risk of [venous thromboembolism] for these patients, further helping us to define the role of antithrombotics in this setting."

Arixtra is approved for use in the European Union and the United States for the prevention of venous thromboembolism in patients undergoing surgery for hip fracture, knee replacement and hip replacement; and in acutely ill patients at high risk for thromboembolic complications.

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

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