Released 27 August 2008

New venous thromboembolism drug 'not better than existing treatments'

Tests on a new drug that prevents venous thromboembolism (VTE) in patients undergoing total knee replacements indicate that the treatment is no more effective than existing standards of care.

Drug companies Bristol-Myers Squibb and Pfizer said that early evaluation of results from a Phase III study of apixaban for the prevention VTE in total knee replacement surgery seemed to show it was unlikely to prove more useful than existing treatments.

The trial compared apixaban - a novel, oral Factor Xa inhibitor - with the US Food& Drug Administration's approved dose of enoxaparin.

While the results showed that apixaban was equally effective, it did not confirm that the drug was significantly more effective than enoxaparin - as previous studies had indicated.

The researchers noted that the major bleeding event rate for apixaban was numerically lower, but not significantly lower, than that of enoxaparin.

Jack Lawrence, vice president of research and development at Bristol-Myers Squibb, commented: "Bristol-Myers Squibb and Pfizer remain enthusiastic and committed to the clinical development program for apixaban."

A spokesman for the Arthritis Research Campaign said it was important to get joint replacement patients up and moving and soon as possible after surgery to reduce the likelihood of suffering a venous thromboembolism.ADNFCR-1096-ID-18750659-ADNFCR

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