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GSK’s Arixtra shows promise in acutely ill patients

A pivotal study has shown GlaxoSmithKline's antithrombotic Arixtra to be effective and well tolerated in acutely ill patients, with the treatment reducing the risk of venous thromboembolism with major bleeding risks comparable to placebo.

Results from the study, named Artemis, demonstrated that treatment with Arixtra (fondaparinux sodium) reduced patients’ risk of overall venous thromboembolism (VTE) by nearly half (46.7%), with no increased risk of major bleeds compared with placebo.

The study was published in the British Medical Journal and evaluated the overall efficacy and safety of Arixtra in acutely medically ill patients aged 60 or older.

Results showed that VTE was detected in 5.6% of patients treated with Arixtra versus 10.5% of patients on placebo, demonstrating a significant reduction in relative risk. In terms of safety, meanwhile, major bleeding occurred in one patient (0.2%) in each group and minor bleeds were observed in 11 patients (2.6%) in the fondaparinux group and four (1%) in the placebo group. No patients in the fondaparinux group and five in the placebo group had fatal pulmonary embolism.

“VTE presents a significant risk to this patient population, however we have had limited understanding of the effectiveness of clot prevention to address VTE in this group,” said Dr Alexander Cohen, honorary consultant vascular physician at King’s College Hospital, London, UK and chairman of the study’s steering committee.

“These results show that Arixtra is an effective and well tolerated treatment that can reduce the risk of VTE for these patients, further helping us to define the role of antithrombotics in this setting,” he continued.

VTE is a potential risk for many acutely ill medical patients admitted to hospital. Acutely ill medical patients may be those with congestive heart failure, respiratory illness, and infectious or inflammatory disease. Each of these acute medical conditions is a strong independent risk factor for VTE, and may also cause prolonged immobilization, another risk factor.