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Long-term efficacy and safety of triple-combination therapy with olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide for hypertension.

Abstract
J Clin Hypertens (Greenwich). 2012;14:149-157. ©2012 Wiley Periodicals, Inc. Most patients with hypertension require combination therapy in order to achieve blood pressure (BP) goals. This 40-week open-label extension of the 12-week double-blind Triple Therapy With Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide in Hypertensive Patients Study (TRINITY) evaluated the efficacy and safety of triple-combination treatments with olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide (OM/AML/HCTZ) in 2112 participants with moderate to severe hypertension. Following 2 weeks of initial treatment with OM 40/AML 5/HCTZ 12.5 mg, participants not achieving BP goal were titrated to OM 40/AML 5/HCTZ 25 mg or OM 40/AML 10/HCTZ 12.5 mg on a randomized basis. At week 16, participants who did not achieve BP goal were further titrated to OM 40/AML 10/HCTZ 25 mg. At the end of the study, 44.5% to 79.8% of participants reached BP goal and the mean BP decreased from 168.6/100.7 mm Hg (baseline BP at randomization) to 125.0 to 136.8 mm Hg/77.8 to 82.5 mm Hg, depending on treatment. Long-term treatment with OM/AML/HCTZ was well tolerated and effective with no new safety concerns.
AuthorsDean J Kereiakes, Steven G Chrysant, Joseph L Izzo Jr, Thomas Littlejohn 3rd, Suzanne Oparil, Michael Melino, James Lee, Victor Fernandez, Reinilde Heyrman
JournalJournal of clinical hypertension (Greenwich, Conn.) (J Clin Hypertens (Greenwich)) Vol. 14 Issue 3 Pg. 149-57 (Mar 2012) ISSN: 1751-7176 [Electronic] United States
PMID22372774 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Copyright© 2012 Wiley Periodicals, Inc.
Chemical References
  • Angiotensin II Type 1 Receptor Blockers
  • Antihypertensive Agents
  • Diuretics
  • Imidazoles
  • Tetrazoles
  • Hydrochlorothiazide
  • Amlodipine
  • olmesartan
Topics
  • Aged
  • Amlodipine (adverse effects, therapeutic use)
  • Angiotensin II Type 1 Receptor Blockers (adverse effects, therapeutic use)
  • Antihypertensive Agents (adverse effects, therapeutic use)
  • Blood Pressure
  • Diuretics (adverse effects, therapeutic use)
  • Double-Blind Method
  • Drug Therapy, Combination (adverse effects)
  • Female
  • Humans
  • Hydrochlorothiazide (adverse effects, therapeutic use)
  • Hypertension (drug therapy)
  • Imidazoles (adverse effects, therapeutic use)
  • Male
  • Middle Aged
  • Severity of Illness Index
  • Tetrazoles (adverse effects, therapeutic use)
  • Time Factors

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