Bristol-Myers Squibb and Pfizer publish ARISTOTLE subanalysis

Bristol-Myers Squibb and Pfizer have revealed the results of a subanalysis of the ARISTOTLE trial.

The findings showed that reductions in stroke or systemic embolism, the number of major bleeding events and mortality demonstrated with Eliquis in comparison to warfarin in the ARISTOTLE trial.

Consistencies were found across subgroups based on the levels of International Normalised Ratio (INR) control in patients with nonvalvular atrial fibrillation.

Study lead author Dr. Lars Wallentin of Uppsala University in Uppsala, Sweden, said: “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 subanalysis was conducted to determine whether the treatment effects of apixaban were similar in centers and patients with high quality warfarin care.”

Variations in time in therapeutic range can impact outcomes for atrial fibrillation patients who are treated for Vitamin K antagonists, such as warfarin for stroke prevention, which leads to an increased risk of stroke when INR levels are below the therapeutic range.

The ARISTOTLE trial randomised 18,201 patients from 1,034 clinical centres across 39 countries, with a centre average TTR being estimated using a linear mixed model based on the real TTRs in warfarin treated patients.

As well as showing consistency over a wide range of warfarin control, findings from the subanalysis indicate a trend towards the reduction of treatment effects at centres, where interaction tests are less reliable due to lower numbers of events.

The results of the subanalysis indicated that the benefits of Eliquis in comparison with warfarin for stroke or systemic embolism, bleeding and mortality seem similar across the range of centres.

However, it is vital that Eliquis is used properly, as discontinuing usage can increase the risk of thrombotic events, with an increased risk of stroke being observed during the transition from Eliquis to warfarin in clinical trials featuring patients with nonvalvular atrial fibrillation.

Posted by Ben Evans