Randomized study of antihypertensive efficacy and safety of combination aliskiren/valsartan vs valsartan monotherapy in hypertensive participants with type 2 diabetes mellitus

J Clin Hypertens (Greenwich). 2013 Feb;15(2):92-100. doi: 10.1111/jch.12032. Epub 2012 Oct 26.

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Aged
  • Amides / adverse effects
  • Amides / therapeutic use*
  • Antihypertensive Agents / adverse effects
  • Antihypertensive Agents / therapeutic use*
  • Blood Pressure / physiology
  • Blood Urea Nitrogen
  • Comorbidity
  • Creatinine / blood
  • Diabetes Mellitus, Type 2 / epidemiology*
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Fumarates / adverse effects
  • Fumarates / therapeutic use*
  • Humans
  • Hypertension / drug therapy*
  • Hypertension / epidemiology*
  • Hypertension / physiopathology
  • Male
  • Middle Aged
  • Severity of Illness Index
  • Tetrazoles / adverse effects
  • Tetrazoles / therapeutic use*
  • Treatment Outcome
  • Valine / adverse effects
  • Valine / analogs & derivatives*
  • Valine / therapeutic use
  • Valsartan

Substances

  • Amides
  • Antihypertensive Agents
  • Fumarates
  • Tetrazoles
  • aliskiren
  • Valsartan
  • Creatinine
  • Valine

Associated data

  • ClinicalTrials.gov/NCT00927394