Evaluation of the dose--response relationship of aliskiren, a direct renin inhibitor, in an 8-week, multicenter, randomized, double-blind, parallel-group, placebo-controlled study in adult patients with stage 1 or 2 essential hypertension

Clinical Therapeutics
Juan G PuigDeborah L Keefe

Abstract

Aliskiren is approved for the treatment of hypertension at once-daily doses of 150 or 300 mg by the US Food and Drug Administration and the European Commission. It is generally well tolerated and provides 24-hour, dose-dependent blood pressure (BP) reduction; however, the effect of the 75-mg dose has been inconsistent in previous trials. This study was designed to assess the efficacy and tolerability of once-daily administration of aliskiren 75 mg and to evaluate the dose-response relationship across all 3 doses of aliskiren (75, 150, and 300 mg). In this 8-week, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, patients aged > or =18 years with stage 1 or 2 essential hypertension entered a 3- to 4-week, single-blind, placebo run-in period. Eligible patients were randomized (1:1:1:1) to receive oral, once-daily doses of aliskiren 75, 150, or 300 mg or placebo. The primary efficacy variable was the change from baseline in mean sitting diastolic BP (msDBP) at the week-8 end point. Tolerability was assessed by monitoring and recording all adverse events (AEs). A total of 642 patients (mean [SD] age, 52.0 [10.73] years; 60.0% male; 80.8% white; mean body weight, 89.2 [18.4] kg [range, 50-160 kg]) were...Continue Reading

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Citations

Nov 17, 2012·Hypertension Research : Official Journal of the Japanese Society of Hypertension·Yongfei ChenFeng Yu
Jun 10, 2017·Journal of Clinical Medicine·Nikolaos-Dimitrios PantzarisDimitrios Velissaris
Apr 1, 2011·European Journal of Cardiovascular Prevention and Rehabilitation : Official Journal of the European Society of Cardiology, Working Groups on Epidemiology & Prevention and Cardiac Rehabilitation and Exercise Physiology·Natale Daniele BrunettiMatteo Di Biase
Nov 22, 2014·The Cochrane Database of Systematic Reviews·Stephen P AdamsJames M Wright
Aug 17, 2012·Expert Review of Cardiovascular Therapy·Benjamin J EpsteinNiren K Shah
Apr 6, 2017·The Cochrane Database of Systematic Reviews·Vijaya M MusiniJames M Wright

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