Jean-Michel Mallion1, Anthony Heagerty, Petra Laeis. 1. Cardiologie et Hypertension Arterielle, Service de Cardiologie et Hypertension artérielle, Hopital A. Michallon CHU, BP 217-38043 Grenoble Cedex, France. jmmallion@chu-grenoble.fr
Abstract
OBJECTIVE: The prevalence of isolated systolic hypertension (ISH) is high in the elderly, and the objective of this study was to compare the antihypertensive efficacy of olmesartan medoxomil with that of nitrendipine in elderly (65-74 years) and very elderly (>/= 75 years) male and female patients with ISH. METHODS: Patients were randomized to 24 weeks of treatment with either olmesartan medoxomil 20 mg daily (n = 256) or nitrendipine 20 mg (n = 126) twice daily, with possible dose increase (to 40 mg daily) and addition of hydrochlorothiazide (HCTZ) 12.5 or 25 mg daily if required. RESULTS: On the primary endpoint [reduction in mean sitting systolic blood pressure (SBP) after 12 weeks of treatment], the two treatments were similar (olmesartan medoxomil, -30.0 mmHg; nitrendipine, -31.4 mmHg). No significant difference between the treatment groups was observed, and non-inferiority of olmesartan medoxomil to nitrendipine was demonstrated using an analysis of covariance (ANCOVA) model. Reductions in mean sitting and standing SBP and diastolic blood pressure (DBP) up to week 24 were also similar with both treatments. Blood pressure (BP) goal attainment rates (sitting SBP </= 135 mmHg) increased consecutively, and were higher with olmesartan medoxomil (62.5%) than with nitrendipine (56.0%) at week 24 (not significant). Both treatments were well tolerated. CONCLUSIONS: In elderly patients with ISH, the mean reduction in SBP produced by olmesartan is similar to that produced by nitrendipine.
RCT Entities:
OBJECTIVE: The prevalence of isolated systolic hypertension (ISH) is high in the elderly, and the objective of this study was to compare the antihypertensive efficacy of olmesartanmedoxomil with that of nitrendipine in elderly (65-74 years) and very elderly (>/= 75 years) male and female patients with ISH. METHODS:Patients were randomized to 24 weeks of treatment with either olmesartanmedoxomil 20 mg daily (n = 256) or nitrendipine 20 mg (n = 126) twice daily, with possible dose increase (to 40 mg daily) and addition of hydrochlorothiazide (HCTZ) 12.5 or 25 mg daily if required. RESULTS: On the primary endpoint [reduction in mean sitting systolic blood pressure (SBP) after 12 weeks of treatment], the two treatments were similar (olmesartanmedoxomil, -30.0 mmHg; nitrendipine, -31.4 mmHg). No significant difference between the treatment groups was observed, and non-inferiority of olmesartanmedoxomil to nitrendipine was demonstrated using an analysis of covariance (ANCOVA) model. Reductions in mean sitting and standing SBP and diastolic blood pressure (DBP) up to week 24 were also similar with both treatments. Blood pressure (BP) goal attainment rates (sitting SBP </= 135 mmHg) increased consecutively, and were higher with olmesartanmedoxomil (62.5%) than with nitrendipine (56.0%) at week 24 (not significant). Both treatments were well tolerated. CONCLUSIONS: In elderly patients with ISH, the mean reduction in SBP produced by olmesartan is similar to that produced by nitrendipine.
Authors: Dean J Kereiakes; Joel Neutel; Kathy A Stoakes; William F Waverczak; Jianbo Xu; Ali Shojaee; Robert Dubiel Journal: J Clin Hypertens (Greenwich) Date: 2009-08 Impact factor: 3.738