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 150/160 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.

Trial registration: ClinicalTrials.gov NCT00927394.

© 2012 Wiley Periodicals, Inc.

Figures

Figure 1

Study design.

Figure 2

Participant disposition.

Figure 3

Least‐square mean (LSM) reductions from baseline to week 8 in 24‐hour, daytime (6 am–10 pm), nighttime (10 pm–6 am), and last‐6‐hour (18–24 hours) mean ambulatory systolic blood pressure (maSBP) in all participants. Error bars represent standard error of the mean.

Figure 4

Profiles of (a) hourly mean ambulatory systolic blood pressure (maSBP) and (b) hourly mean ambulatory diastolic blood pressure (maDBP) at baseline and week 8 in the overall ambulatory blood pressure monitoring population.