Key result
Aliskiren/hydrochlorothiazide reduces SBP by ~16 mmHg compared to aliskiren alone.
Why the study?
The efficacy, safety, and tolerability of aliskiren/hydrochlorothiazide single-pill combinations in patients with hypertension inadequately responsive to aliskiren monotherapy were evaluated.
Does a single-pill combination of aliskiren/hydrochlorothiazide improve blood pressure reduction in patients with hypertension and an inadequate response to aliskiren monotherapy?
Population
880 patients with hypertension and inadequate BP response to aliskiren monotherapy
Comparison
Aliskiren/HCT 300/25 mg or 300/12.5 mg vs aliskiren 300 mg monotherapy
Design
Randomized double-blind controlled trial
Follow-up
8 weeks
Authors
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Aliskiren/HCT SPC improves BP control in nonresponders; extends RCT evidence for combinations in resistant hypertension.
RCT (n=880)
Double-blind
randomized
Does a single-pill combination of aliskiren/hydrochlorothiazide improve blood pressure reduction in patients with hypertension and an inadequate response to aliskiren monotherapy?
p-value: p=<0.001
Aliskiren/hydrochlorothiazide single-pill combinations provide clinically significant additional blood pressure reductions and improved control rates compared to aliskiren monotherapy in non-responders.
Nickenig et al. (2008) conducted an RCT in hypertension with inadequate BP response to aliskiren monotherapy (n=880). aliskiren/hydrochlorothiazide vs. aliskiren 300 mg monotherapy was evaluated on least-squares mean changes in mean sitting systolic/diastolic BP from baseline (p=<0.001). Aliskiren/hydrochlorothiazide 300/25 mg and 300/12.5 mg significantly reduced msSBP/DBP by 15.9/11.0 and 13.5/10.5 mmHg vs 8.0/7.4 mmHg with aliskiren alone (p<0.001).
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