Randomized Study of Antihypertensive Efficacy and Safety of Combination Aliskiren/Valsartan vs Valsartan Monotherapy in Hypertensive Participants With Type 2 Diabetes Mellitus
Article first published online: 26 OCT 2012
© 2012 Wiley Periodicals, Inc.
The Journal of Clinical Hypertension
Volume 15, Issue 2, pages 92–100, February 2013
How to Cite
Bakris, G. L., Oparil, S., Purkayastha, D., Yadao, A. M., Alessi, T. and Sowers, J. R. (2013), Randomized Study of Antihypertensive Efficacy and Safety of Combination Aliskiren/Valsartan vs Valsartan Monotherapy in Hypertensive Participants With Type 2 Diabetes Mellitus. The Journal of Clinical Hypertension, 15: 92–100. doi: 10.1111/jch.12032
- Issue published online: 22 JAN 2013
- Article first published online: 26 OCT 2012
- Manuscript received: July 17, 2012; revised: September 11, 2012; accepted: September 13, 2012
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.