Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) today announced results of a pre-specified subanalysis of the Phase 3 ARISTOTLE trial in relation to patient age. ARISTOTLE was designed to evaluate the efficacy and safety of Eliquis compared to warfarin for reducing the risk of stroke or systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). This subanalysis found consistent results across age groups for reducing the risk of stroke and systemic embolism and reducing the risk of all-cause death with fewer bleeding events. Owing to the higher risk at older age (age 75 and older), the absolute benefit to patients with NVAF was greater with Eliquis in the older population. These data were published today in the European Heart Journal.
Eliquis was more effective than warfarin in reducing the risk of stroke and reducing mortality across age groups, and was associated with less major bleeding, less total bleeding and less intracranial hemorrhage, regardless of age. The p-value for interaction across age groups was non-significant (p>0.11 for all) for the major outcomes of stroke and systemic embolism, major bleeding, and death, meaning that the results of this subanalysis were consistent with the overall results of the ARISTOTLE trial.
“Patients with atrial fibrillation are at an increased risk of major cardiovascular events such as stroke, and this risk increases substantially with age,” said study lead author Dr. Sigrun Halvorsen, Department of Cardiology, Oslo University Hospital, Norway. “ Eliquis has demonstrated superiority versus warfarin for reducing the risk of stroke and all-cause mortality with fewer major bleeding events in patients with NVAF with consistency across age groups, including patients 75 and older and the very elderly over the age of 80.”
Although the ARISTOTLE trial was neither designed nor powered to investigate the differences for safety and efficacy of Eliquis compared to warfarin for individual age groups, a pre-specified subanalysis of the ARISTOTLE trial was performed according to age. The efficacy and safety of Eliquis compared with warfarin were assessed according to age during the 1.8 years median follow-up. Of the trial population, 30 percent were under age 65, 39 percent were 65 to 74 years old and 31 percent were 75 years or older. In the overall ARISTOTLE trial population, the rates of stroke, major bleeding and death were higher in the older age groups (p<0.001 for all) across treatment groups.IMPORTANT SAFETY INFORMATION FOR ELIQUIS BOXED WARNING: DISCONTINUING ELIQUIS IN PATIENTS WITHOUT ADEQUATE CONTINUOUS ANTICOAGULATION INCREASES RISK OF STROKE. Discontinuing ELIQUIS places patients at an increased risk of thrombotic events. An increased rate of stroke was observed following discontinuation of ELIQUIS in clinical trials in patients with nonvalvular atrial fibrillation. If anticoagulation with ELIQUIS must be discontinued for a reason other than pathological bleeding, coverage with another anticoagulant should be strongly considered . CONTRAINDICATIONS - Active pathological bleeding