Randomized Study of Antihypertensive Efficacy and Safety of Combination Aliskiren/Valsartan vs Valsartan Monotherapy in Hypertensive Participants With Type 2 Diabetes Mellitus

Abstract

In this double-blind study, 1143 hypertensive participants with type 2 diabetes and stage 1 or 2 chronic kidney disease (CKD) were randomized to receive combination aliskiren/valsartan 150/160mg or valsartan 160mg monotherapy for 2weeks, with force-titration to 300/320mg and 320mg, respectively, for another 6weeks. Ambulatory blood pressure (ABP), the primary outcome, was available for 665 participants. Reductions from baseline to week 8 in 24-hour ABP were -14.1/-8.7mmHg with aliskiren/valsartan vs -10.2/-6.3mmHg with valsartan (P 40mg/dL or serum creatinine values >2.0mg/dL. There were no confirmed cases of serum potassium values ≥6.0mEq/L. Combination aliskiren/valsartan has additive effects on blood pressure reduction and tolerability similar to valsartan in hypertensive/diabetic participants with early-stage (stages 1 and 2) CKD. ©2012 Wiley Periodicals, Inc.