October 26, 2012Open Access
View Full PaperRandomized Study of Antihypertensive Efficacy and Safety of Combination Aliskiren/Valsartan vs Valsartan Monotherapy in Hypertensive Participants With Type 2 Diabetes Mellitus
Key Result
Combination aliskiren/valsartan significantly reduced 24-hour ambulatory blood pressure compared to valsartan monotherapy (-14.1/-8.7 vs -10.2/-6.3 mm Hg; P<.001) in patients with diabetes and CKD.
Study Design
Type
RCT (n=1,143)
Blinding
Double-blind
Randomization
randomized
Structured PICO
Does combination aliskiren/valsartan reduce ambulatory blood pressure in hypertensive participants with type 2 diabetes and stage 1 or 2 CKD compared to valsartan monotherapy?
P
Population
1,143 hypertensive participants with type 2 diabetes and stage 1 or 2 chronic kidney disease, followed for 8 weeks.
I
Intervention
Combination aliskiren/valsartan 150/160 mg for 2 weeks, force-titrated to 300/320 mg for another 6 weeks
C
Comparator
Valsartan 160 mg monotherapy for 2 weeks, force-titrated to 320 mg for another 6 weeks
O
Outcome
Ambulatory blood pressure (ABP) at week 8surrogate
Combination aliskiren/valsartan provides additive blood pressure reduction compared to valsartan monotherapy with similar tolerability in hypertensive patients with type 2 diabetes and early-stage CKD.
Main Result
Absolute Event Rate: -14.1% vs -10.2%
p-value: p=<.001
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 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.