Aliskiren for geriatric lowering of systolic hypertension: A randomized controlled trial

D. A. Duprez, M. A. Munger, J. Botha, D. L. Keefe, A. N. Charney

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63 Scopus citations

Abstract

Efficacy and safety of the direct renin inhibitor aliskiren was compared with ramipril for treatment of essential systolic hypertension in elderly patients. A 36-week, randomized, double-blind, parallel-group, active-controlled, optional-titration study was performed in 901 patients (aliskiren, n457; ramipril, n444) 65 years of age with systolic blood pressure (SBP) 140 mm Hg. Aliskiren 150-300 mg per day or ramipril 5-10 mg per day for was administered for 12 weeks with optional add-on therapy of hydrochlorothiazide (12.5-25 mg per day) at week 12 and amlodipine (5-10 mg per day) at week 22. The primary end point was non-inferiority of aliskiren vs ramipril monotherapy for change from baseline in mean sitting SBP (msSBP) at week 12. Decreases from baseline msSBP and mean sitting diastolic BP with aliskiren monotherapy (14.0 and 5.1 mm Hg, respectively) were non-inferior (P0.001 for both values) and superior to ramipril monotherapy (11.6, 3.6 mm Hg; P0.02, P0.01, respectively). More patients achieved BP control with aliskiren (42%) than ramipril (33%; P0.01). At week 36, fewer patients receiving aliskiren-based therapy required add-on treatment with hydrochlorothiazide or amlodipine (P0.01 and 0.048, respectively). Tolerability was similar, but more patients receiving ramipril reported cough (P0.001). In elderly patients with systolic hypertension, aliskiren proved to be more effective and better overall anti-hypertensive therapy compared to ramipril.

Original languageEnglish (US)
Pages (from-to)600-608
Number of pages9
JournalJournal of Human Hypertension
Volume24
Issue number9
DOIs
StatePublished - Sep 2010

Bibliographical note

Funding Information:
This study was funded by Novartis Pharma AG, Basel, Switzerland. Novartis was represented on the trial steering committee in the study design, analysis and interpretation of data. The sponsor provided study drug preparations. Editorial assistance was provided by Complete Healthcare Communications Inc. (Chadds Ford, PA, USA) and supported by Novartis Pharmaceuticals Corporation.

Keywords

  • aliskiren
  • blood pressure
  • combination therapy
  • direct renin inhibition
  • ramipril

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