Comparative efficacy and safety of combination aliskiren/amlodipine and amlodipine monotherapy in African Americans with stage 2 hypertension

Abstract

Initial multiple drug therapy for hypertension achieves greater and quicker reductions and higher blood pressure (BP) control rates than monotherapy. This 8-week, prospective, multicenter, randomized, double-blind study compared the efficacy and safety of the initial combination of aliskiren/amlodipine with amlodipine monotherapy in African Americans with stage 2 hypertension. After a 1- to 4-week washout, patients received aliskiren/amlodipine 150/5mg or amlodipine 5mg for 1week and then were force-titrated to aliskiren/amlodipine 300/10mg or amlodipine 10mg for 7weeks. At week 8, greater reductions in mean sitting systolic BP were obtained with aliskiren/amlodipine (n=220) than with amlodipine (n=223) (least squares mean change [standard error of the mean], -34.1 [1.14] mmHg vs -28.9 [1.12] mmHg; P <140/90mmHg) with aliskiren/amlodipine than with amlodipine at week 8 (57.3% vs 48.0%; P= .051). Both treatment groups had similar adverse event rates (35.0% and 32.7%, respectively). The most common adverse events were peripheral edema (7.7% with aliskiren/amlodipine and 9.0% with amlodipine), headache, fatigue, and nausea. The combination of aliskiren/amlodipine reduced peripheral, ambulatory, and central BP more than amlodipine alone with similar tolerability in African Americans with stage 2 hypertension. © 2011 Wiley Periodicals, Inc.