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. © 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins.

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

PEDRINELLI, ROBERTO;
2012-01-01

Abstract

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. © 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins.
2012
Omboni, Stefano; Malacco, Ettore; Mallion, Jean Michel; Volpe, Massimo; Zanchetti, Alberto; on behalf of the Study Group: Malacco, E; Auteri, A; Volpe, M; Mallion, Jm; Baghestanian, M; Eber, B; Zweiker, R; Riegelnik, V; Van Mieghem, W; Mallion, Jm; Ducailar, G; Panzer, Pk; Kresse, Wr; Carewicz, O; Iserloh, J; Krause, Kh; Prechtel, E; Naudts, If; Schmidt, A; Zimmermann, U; Borbas, E; Kremastinos, D; Triantafyllidi, H; Stefanadis, C; Barton, J; Ambrosio, Gb; Anastasio, L; Antonelli, B; Antonucci, G; Aurelio, G; Auteri, A; Baldi, F; Battistello, L; Baule, Gm; Bellazzi, R; Blasio, A; Bonollo, V; Borello, L; Campanini, M; Candido, R; Capobianco, G; Capuano, V; Caruso, D; Corbara, F; Casanova, R; Cerasola, G; Cianflone, D; Ciconte, V; Cipriani, M; Cocchi, R; Cucchini, F; Dallemule, J; D'Amico, F; De Cesaris, R; De Curtis, G; Defeo, ; Deferrari, G; Dei Cas, L; Del Carratore, G; Demartino, M; Desideri, G; Destro, M; Di Biase, M; Di Somma, S; Donadon, V; Doronzo, B; Fariello, R; Feraco, E; Ferri, C; Fiorini, F; Fogari, R; Foresti, A; Galasso, D; Gargiulo, A; Gaudio, G; Gavazzi, A; Giannatempo, C; Guzzardi, G; Iaconelli, G; Lacchè, A; Laghi, F; Lechi, A; Lembo, G; Lettica, G; Licata, G; Locatelli, F; Maimone, I; Manfrè, M; Manfredini, R; Marracci, G; Mauro, Gf; Mazzuca, L; Melandri, F; Meloni, L; Mezzetti, A; Minutiello, L; Mondillo, S; Montereggi, A; Mos, L; Musca, ; Nami, R; Nigro, P; Novo, S; Noto, R; Olivieri, O; Palasciano, G; Palatini, P; Panettieri, Mi; Pedrinelli, Roberto; Perticone, F; Pini, C; Pirrone, Gt; Portaluppi, F; Prinzi, D; Pulitanò, G; Pupilella, T; Puzzolante, V; Radaeli, A; Raisaro, A; Rappelli, A; Ricciardi, B; Fanelli, F; Rovero, E; Russo, F; Uriarte, J; Santonastaso, M; Scala, A; Schipani, F; Sechi, L; Serviddio, G; Sganzerla, P; Spadola, V; Sprovieri, M; Stornello, M; Tamburino, C; Totaro, G; Turiel, M; Varì, N; Venco, A; Ventrella, F; Villa, G; Volpe, M; Uguccioni, M; Narkiewicz, K; Chrostowska, M; Napora, P; Gornikiewicz Brzezicka, B; Graczak, I; Klimkiewicz, J; Jesewska, M; Gamiz, Jl; Olivan, J; Puig, J; Extremera, B; Lopez, P; Martinez, J; Adrian, M; Coca, A; Doménech, M.
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