title: Efficacy of olmesartan/amlodipine combination therapy in reducing ambulatory blood pressure in moderate-to-severe hypertensive patients not controlled by amlodipine alone.
abstract: This previously unpublished, preplanned analysis investigated the efficacy of the olmesartan/amlodipine combination at different doses on 24-h blood pressure (BP) control, as well as assessed trough estimation of trough-to-peak ratio (TPR) and smoothness index (SI). Ambulatory BP monitoring was performed in patients with moderate-to-severe hypertension whose BP was inadequately controlled after 8 weeks' treatment with amlodipine 5 mg. Patients were randomized to continue with amlodipine 5 mg or to receive olmesartan/amlodipine 10/5, 20/5 or 40/5 mg for 8 weeks (Period II). Patients not achieving BP control were uptitrated to a more powerful regimen for another 8 weeks (Period III). During Period II, each olmesartan/amlodipine combination reduced 24-h systolic and diastolic BP (SBP/DBP), as well as morning and early morning SBP/DBP, significantly more than amlodipine 5 mg (P<0.001 for all). TPRs were higher in each olmesartan/amlodipine group than with amlodipine 5 mg, and SI values showed dose-related increases; olmesartan/amlodipine 40/5 mg produced a significantly higher SI for SBP and DBP (1.55 and 1.33, respectively) than amlodipine 5 mg (0.96 and 0.77, respectively, P<0.0001 for each). During Period III, uptitrated patients showed further BP reductions, which were largest in those on olmesartan/amlodipine 40/10 mg. SI values increased in uptitrated patients and were highest with olmesartan/amlodipine 40/10 mg (SBP 1.62/DBP 1.41). The olmesartan/amlodipine combination effectively reduces BP over 24 h, including the morning hours, in a dose-related manner. Compared with amlodipine alone, the olmesartan/amlodipine combination has a better 24-h coverage (TPR) and a dose-related improvement in BP lowering homogeneity (SI).
authors.affiliation: Department of Cardiology, S. Luca Hospital, IRCCS Istituto Auxologico Italiano, Milan, Italy.
authors.forename: Grzegorz
authors.initials: G
authors.lastname: Bilo
authors.affiliation: HaaPACS GmbH, Bahnhofstr. 19c, Schriesheim, Germany.
authors.forename: Winfried
authors.initials: W
authors.lastname: Koch
authors.affiliation: 1] Department of Cardiology, S. Luca Hospital, IRCCS Istituto Auxologico Italiano, Milan, Italy [2] Department of Cardiology, Jichi Medical University School of Medicine, Tochigi, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Hoshide
authors.affiliation: 1] Department of Cardiology, S. Luca Hospital, IRCCS Istituto Auxologico Italiano, Milan, Italy [2] Department of Clinical Medicine and Prevention, University of Milano-Bicocca, Milan, Italy.
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Parati
mesh_terms: D000328:Adult; D000368:Aged; D017311:Amlodipine / Q000494:pharmacology / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000494:pharmacology / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects*; D018660:Blood Pressure Monitoring, Ambulatory; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D007093:Imidazoles / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D019233:Retreatment; D013777:Tetrazoles / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D007093:Imidazoles; D013777:Tetrazoles; D017311:Amlodipine; C437965:olmesartan