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.

• Authors: George L Bakris, Suzanne Oparil, Das Purkayastha, Anthony M Yadao, Thomas Alessi, James R Sowers
• Journal: Journal of clinical hypertension (Greenwich, Conn.) (J Clin Hypertens (Greenwich)) Vol. 15 Issue 2 Pg. 92-100 (Feb 2013) ISSN: 1751-7176 [Electronic] United States
• PMID: 23339726 (Publication Type: Journal Article, 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.)
• Copyright: © 2012 Wiley Periodicals, Inc.

Chemical References

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

Topics

• Aged
• Amides (adverse effects, therapeutic use)
• Antihypertensive Agents (adverse effects, 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, therapeutic use)
• Humans
• Hypertension (drug therapy, epidemiology, physiopathology)
• Male
• Middle Aged
• Severity of Illness Index
• Tetrazoles (adverse effects, therapeutic use)
• Treatment Outcome
• Valine (adverse effects, analogs & derivatives, therapeutic use)
• Valsartan