Safety and efficacy of the oral direct renin inhibitor aliskiren in elderly patients with hypertension

Abstract

Objectives. To evaluate the efficacy, safety and tolerability of aliskiren in elderly patients (≥65 years old) with essential hypertension. Methods. In this double-blind, multicenter study, 355 elderly patients with hypertension [office mean sitting systolic blood pressure (msSBP) ≥145-< 180 mmHg and mean 24-h ambulatory systolic BP (ASBP) ≥135 mmHg] were randomized to once-daily treatment for 8 weeks with aliskiren 75 mg (n = 91), 150 mg (n = 84), 300 mg (n = 94) or the comparator lisinopril 10 mg (n = 86). The primary efficacy variable was change in mean 24-h ASBP. Results. At endpoint, aliskiren 75 mg, 150 mg, 300 mg and lisinopril 10 mg lowered mean 24-h ASBP (least-squares mean ± SEM) by 8.4 ± 0.8, 7.1 ± 0.8, 8.7 ± 0.8 and 10.2 ± 0.9 mmHg, and mean 24-h ambulatory diastolic BP by 4.5 ± 0.5, 3.6 ± 0.5, 3.9 ± 0.5 and 6.3 ± 0.5 mmHg, respectively, with no significant difference between aliskiren doses. The trough-to-peak ratio for ASBP reduction with aliskiren 75 mg, 150 mg, 300 mg and lisinopril 10 mg was 0.77, 0.64, 0.79 and 0.87, respectively. All treatments lowered office msSBP and mean sitting diastolic BP (msDBP) compared with baseline. A significantly greater proportion of patients receiving aliskiren 300 mg achieved BP control (msSBP/msDBP < 140/90 mmHg) compared with those receiving aliskiren 75 mg (36.2% vs 24.2%, p = 0.033). There was no evidence of dose-related increases in the rate of adverse events with aliskiren treatment. Conclusions. Aliskiren, a novel direct renin inhibitor, provides effective 24-h BP lowering with no evidence of dose-related increases in the incidence of adverse events in elderly patients with hypertension.