B-MS/Pfizer anti-clotting drug shows promise

The anti-clotting drug apixaban which is being developed by USA-based drug majors Bristol-Myers Squibb and Pfizer, has met its primary safety and efficacy goals in a mid-stage trial involving deep vein thrombosis patients, according to CNN Money and other media reports.

The 12-week Phase II study recruited 520 DVT patients who were provided with one of four treatment regimens, either 5mg or 10mg of apixaban twice a day, 20mg once daily or an injectable anticoagulent plus warfarin in the control group. The results showed that the rate of DVT incidents in each of the three drug-treated groups were 6%, 5.6% and 2.6%, respectively, compared with 4.2% in the control arm. The bleeding rates across the four treatment groups were comparable (8.6%, 4.5%, 7.3% and 7.9%), while none of the three drug regimens were associated with liver toxicity.

The findings were announced by lead investigator Harry Buller, chairman of the department of vascular medicine at the Academic Medical Center in Amsterdam, Netherlands, at this year's meeting of the International Society on Thrombosis and Hemostasis in Geneva, Switzerland. Dr Buller explained that, unlike current anticoagulants such as heparin and warfarin, which must be injected or given intravenously, apixaban is an oral agent that does not require regular monitoring or dosage adjustments.