Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) today announced the results of a pre-specified subanalysis of the Phase 3 ARISTOTLE trial that assessed the effect of blood pressure control on outcomes as well as the treatment effect of Eliquis (apixaban) compared to warfarin according to blood pressure control. 1 The results showed that poor blood pressure control was associated with a substantially higher risk of stroke or systemic embolism, independent of Eliquis or warfarin treatment. However, this subanalysis found consistent results for Eliquis versus warfarin in reducing the risk of stroke, regardless of blood pressure control. 1 These data will be presented Saturday, March 29, at the American College of Cardiology’s (ACC) 63rd Annual Scientific Session in Washington, D.C.
“High blood pressure is a risk factor for stroke in patients with atrial fibrillation. In this analysis, poorly controlled blood pressure at any time during the trial increased the risk of stroke by approximately 50 percent. The results for apixaban compared to warfarin in reducing the risk of stroke were consistent regardless of blood pressure,” said study lead author Meena Rao, MD, MPH, Duke Clinical Research Institute at Duke University Medical Center. “These data highlight the critical importance of blood pressure control in addition to anticoagulation in helping to lower the risk of stroke in patients with atrial fibrillation.”
In ARISTOTLE, a total of 15,916 (87.5 percent) patients had a history of hypertension requiring treatment. During the trial, 50 percent of patients had poorly controlled hypertension (defined as systolic blood pressure > 140 mm Hg and/or diastolic blood pressure > 90 mm Hg) at some point. Poorly controlled hypertension during the course of the trial was associated with a significant 53 percent increase in the risk of stroke or systemic embolism. Eliquis was consistent in reducing the risk of stroke or systemic embolism versus warfarin in patients with and without poor blood pressure control during the trial (p for interaction = 0.97). 1
In this subanalysis, the effect of Eliquis in reducing the risk of stroke and systemic embolism versus warfarin was consistent with the main results of the ARISTOTLE trial. Further, the effect of Eliquis in reducing the risk of stroke and systemic embolism versus warfarin was also consistent with the results of the ARISTOTLE trial in previously published subanalyses of other comorbidities, including congestive heart failure, advanced age, renal impairment and prior stroke.A total of 11 Bristol-Myers Squibb/Pfizer alliance-sponsored abstracts, including this ARISTOTLE subanalysis, were accepted for presentation at the American College of Cardiology’s 63rd Annual Scientific Session.