ORIGINAL RESEARCH ARTICLE Antihypertensive Efficacy and Safety of Olmesartan Medoxomil and Ramipril in Elderly Mild to Moderate Essential Hypertensive Patients With or Without Metabolic Syndrome A Pooled Post Hoc Analysis of Two Comparative Trials Stefano Omboni • Ettore Malacco • Jean-Michel Mallion • Massimo Volpe Published online: 16 November 2012 Ó Springer International Publishing Switzerland 2012 Abstract Background Two recent identically designed trials (one Italian and one European multinational) have compared the head-to-head efficacy and safety of the angiotensin II receptor blocker olmesartan medoxomil and the angioten- sin converting enzyme inhibitor ramipril, in elderly patients with essential hypertension. Objective The aim of the present study was to assess the antihypertensive efficacy of olmesartan and ramipril in elderly patients with hypertension, with or without meta- bolic syndrome, by performing a pooled analysis of data from the two head-to-head trials. Methods After a 2-week, placebo wash-out, 1,453 treated or untreated elderly hypertensive patients aged 65–89 years [with sitting office diastolic blood pressure (DBP) 90–109 mmHg and/or sitting office systolic BP (SBP) 140–179 mmHg] were randomized to 12-weeks of double- blind treatment with olmesartan 10 mg or ramipril 2.5 mg once daily. Treatment could be up-titrated to 20 and 40 mg for olmesartan, and 5 and 10 mg for ramipril, after the first 2 and 6 weeks, respectively, in patients with inadequately controlled BP (BP C140/90 mmHg for non-diabetics and C130/80 mmHg for diabetics). Office BP was measured at randomization and after 2, 6 and 12 weeks of treatment. 24-h ambulatory BP recordings were obtained at random- ization and after 12 weeks. Results Of the 1,426 patients in the intent-to-treat anal- ysis, 735 (51.5 %) had metabolic syndrome (olmesartan, n = 372; ramipril, n = 363). After 12 weeks of treatment, baseline-adjusted office BP reductions were greater (p \ 0.05) with olmesartan (SBP 17.0 mmHg; 95 % CI 18.4, 15.6; DBP 9.6 mmHg; 95 % CI 10.4, 8.8) than with ramipril (SBP 14.7 mmHg; 95 % CI 16.1, 13.2; DBP 8.4 mmHg; 95 % CI 9.2, 7.6) in patients with metabolic syndrome. In these patients, BP normalization rates were also greater with olmesartan than with ramipril (46.0 vs. 35.8 %, p \ 0.01). Similarly, in patients without metabolic syndrome, the antihypertensive efficacy of olmesartan was also significantly (p \ 0.05) better than that of ramipril. In the subgroup of patients with valid ambulatory BP (ABP) recordings and metabolic syndrome (olmesartan, n = 182; ramipril, n = 170), the reduction in mean 24-h ABP was greater with olmesartan (SBP 10.2 mmHg; 95 % CI 11.8, 8.6; DBP 6.6 mmHg; 95 % CI 7.5, 5.6) than with ramipril (SBP 8.5 mmHg; 95 % CI 10.2, 6.9; DBP 4.7 mmHg; 95 % CI 5.7, 3.7), with a statistically significant (p \ 0.01) dif- ference for the DBP comparison. The proportion of patients experiencing drug-related adverse events was comparable in patients with (olmesartan 2.4 % vs. ramipril 2.8 %) and without (3.5 vs. 3.7 %) metabolic syndrome. On behalf of the ESPORT Study Group. EudraCT clinical trial numbers: 2004-001616-31 (Italian study) and 2004-002077-23 (European study). S. Omboni (&) Italian Institute of Telemedicine, Via Colombera 29, 21048 Solbiate Arno (Varese), Italy e-mail: stefano.omboni@iitelemed.org E. Malacco Department of Internal Medicine, Ospedale L. Sacco, University of Milan, Milan, Italy J.-M. Mallion Cardiology and Arterial Hypertension, CHU de Grenoble, Grenoble, France M. Volpe Division of Cardiology, II Faculty of Medicine, University of Rome ‘‘La Sapienza’’ and IRCCS Neuromed, Pozzilli (IS), Italy Drugs Aging (2012) 29:981–992 DOI 10.1007/s40266-012-0030-3