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Twenty-four hour and early morning blood pressure control of olmesartan vs. ramipril in elderly hypertensive patients: pooled individual data analysis of two randomized, double-blind, parallel-group studies

Omboni, Stefanoa; Malacco, Ettoreb; Mallion, Jean-Michelc; Volpe, Massimod; Zanchetti, Albertoeon behalf of the Study Group

doi: 10.1097/HJH.0b013e32835466ac
ORIGINAL PAPERS: Therapeutic aspects

Objective: To assess the antihypertensive efficacy of olmesartan medoxomil and ramipril on 24-h ambulatory blood pressure (ABP) in elderly hypertensive patients by pooled data analysis of two studies with identical designs (one Italian, one European).

Methods: After a 2-week placebo wash-out 1453 elderly hypertensive patients (65–89 years; sitting office DBP 90–109 mmHg and/or sitting office SBP 140–179 mmHg) were randomized to a 12-week double-blind treatment with olmesartan medoxomil 10 mg or ramipril 2.5 mg once-daily, up-titrated (20 and 40 mg olmesartan medoxomil; 5 and 10 mg ramipril) after 2 and 6 weeks in patients without normalized office BP. 24-h ABP was recorded at randomization and after 12 weeks.

Results: In 715 patients with valid baseline and end-of-treatment recordings baseline-adjusted 24-h SBP and DBP reductions were greater with olmesartan medoxomil (n = 356) than with ramipril (n = 359) [between-treatment differences and 95% confidence interval (CI), SBP: 2.2 (3.8, 0.6), P = 0.006; DBP: 1.3 (2.2, 0.3), P = 0.009]. Olmesartan medoxomil showed larger BP reductions in the last 6 h from the dosing interval and higher smoothness indices than ramipril. Olmesartan medoxomil reduced the SBP morning rise [−2.8 (−4.9, −0.8) mmHg], whereas ramipril did not [+1.5 (–0.6, +3.6) mmHg; P = 0.004 between-treatments]. Five hundred and eighty-two patients with sustained hypertension (office and 24-h ambulatory hypertension) showed the largest antihypertensive effect, with between-treatment differences still in favor of olmesartan medoxomil [SBP: 2.1 (3.9, 0.4), P = 0.019; DBP: 1.2 (2.3, 0.1), P = 0.032].

Conclusions: Olmesartan medoxomil provides a more effective and sustained 24-h BP control than ramipril in elderly hypertensive patients, particularly in the hours farthest from last intake.

aItalian Institute of Telemedicine, Varese

bDepartment of Internal Medicine. Ospedale L. Sacco, University of Milan, Milan, Italy

cCardiology and Arterial Hypertension, CHU de Grenoble, Grenoble, France

dDivision of Cardiology, II Faculty of Medicine, University of Rome ‘La Sapienza’ and IRCCS Neuromed, Pozzilli, Isernia

eCentro di Fisiologia Clinica e Ipertensione Università di Milano and Istituto Auxologico Italiano, Milan, Italy

Correspondence to Dr Stefano Omboni, Italian Institute of Telemedicine, Via Colombera 29, 21048 Solbiate Arno (Varese), Italy. Tel: +39 0331 984529; fax: +39 0331 984530; e-mail:

Abbreviations: ABP, ambulatory blood pressure; ACE, angiotensin-converting enzyme; ARB, angiotensin II receptor blocker; BP, blood pressure; SD, standard deviation

Received 10 November, 2011

Revised 8 March, 2012

Accepted 3 April, 2012

© 2012 Lippincott Williams & Wilkins, Inc.