Positive data from Phase III study of Eliquis (BMS/Pfizer) for VTE prevention

Results of the Phase III AMPLIFY-EXT trial evaluating Eliquis (apixaban), from BMS/Pfizer, vs placebo for preventing VTE, shows it demonstrated superiority in reducing recurrent VTE and death from any cause (11.6% in the placebo group, compared with 3.8% and 4.2% in the Eliquis groups. Eliquis also was superior to placebo for the predefined secondary efficacy outcome of recurrent VTE and VTE-related death (8.8% with placebo, 1.7% in Eliquis 2.5 mg and 5 mg groups). Both endpoints, the primary and secondary efficacy outcomes, were statistically significant (p<0.001).>

The rate of the primary safety outcome of major bleeding was comparable across treatment groups. The rate of the composite of major bleeding and clinically relevant non-major bleeding for the 5 mg treatment group (4.3%) was higher versus the placebo group (2.7%), while the rate for the 2.5 mg treatment group (3.2%) was similar to the placebo group. The findings were published online in The New England Journal of Medicine. See: "Apixaban for Extended Treatment of Venous Thromboembolism" Giancarlo Agnelli et al. NEJM , December 8, 2012DOI: 10.1056/NEJMoa1207541