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

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 150/160 mg or valsartan 160 mg monotherapy for 2 weeks, with force‐titration to 300/320 mg and 320 mg, respectively, for another 6 weeks. 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/−8.7 mm Hg with aliskiren/valsartan vs −10.2/−6.3 mm Hg with valsartan ( P <.001). Adverse events were reported in 202 participants (35.2%) taking aliskiren/valsartan and 182 participants (32.2%) taking valsartan. No participant had blood urea nitrogen values >40 mg/dL or serum creatinine values >2.0 mg/dL. There were no confirmed cases of serum potassium values ≥6.0 mEq/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. J Clin Hypertens (Greenwich). 2012;00:00–00. ©2012 Wiley Periodicals, Inc.