Positive results from sub-analysis of Eliquis ARISTOTLE trial

US drug major Bristol-Myers Squibb (NYSE: BMY) and partner Pfizer (NYSE: PFE) reported results from a pre-specified sub-analysis of the ARISTOTLE trial (n=18,201) showing that the reduction in stroke or systemic embolism, number of major bleeding events and mortality demonstrated with Eliquis (apixaban) compared to warfarin were consistent across subgroups defined based on levels of International Normalized Ratio control in patients with non-valvular atrial fibrillation.

Based on the results of the sub-analysis, the benefits of Eliquis (which is already marketed in the USA and Europe) compared with warfarin for stroke or systemic embolism, and mortality appear similar across the range of centers’ and patients’ quality of INR control.

“Concerning the quality of warfarin treatment, there is a large variation in time in therapeutic range among different countries and centers, which affects outcomes. This sub-analysis was conducted to determine whether the treatment effects of apixaban were similar in centers and patients with high quality warfarin care,” said study lead author Lars Wallentin of Uppsala University in Uppsala, Sweden, adding: “These additional analyses supported that the primary results of ARISTOTLE were consistent across a broad range of quality of warfarin management.”