title: Olmesartan/amlodipine/hydrochlorothiazide in obese participants with hypertension: a TRINITY subanalysis.
abstract: The objective of this prespecified TRINITY study subgroup analysis was to assess the efficacy and safety of triple-combination treatment with olmesartan medoxomil (OM) 40 mg, amlodipine besylate (AML) 10 mg, and hydrochlorothiazide (HCTZ) 25 mg vs the component dual-combination treatments in obese (body mass index [BMI] ≥30 kg/m(2) ) and nonobese (BMI <30 kg/m(2) ) hypertensive participants. The double-blind treatment period primary end point was the least-squares (LS) mean reduction in seated diastolic BP (SeDBP) at week 12 (end of the double-blind period). Of the 2492 randomized participants, 1555 (62.4%) had BMI ≥30 kg/m(2) . Irrespective of BMI, triple-combination treatment resulted in greater LS mean reductions in seated BP (SeBP) (≥30 kg/m(2) , 6.7-10.5/4.5-7.3 mm Hg; <30 kg/m(2) , 5.1-8.6/2.5-6.0 mm Hg [P<.005] vs dual-combination treatments for both subgroups) at week 12. Furthermore, triple-combination treatment enabled a greater proportion of participants to reach BP goal vs the dual-combination treatments (≥30 kg/m(2) , 62% vs 31%-46% [P<.0001]; <30 kg/m(2) , 69% vs 41%-55% [P<.005]) at week 12. SeBP reduction and goal attainment (≥30 kg/m(2) , 63%; <30 kg/m(2) , 67%) was maintained through week 52/early termination. Triple-combination treatment was well tolerated in both BMI subgroups.
authors.affiliation: Sterling Research Group, Cincinnati, OH 45219, USA. eroth@sterlingresearch.org
authors.forename: Eli M
authors.initials: EM
authors.lastname: Roth
authors.forename: Suzanne
authors.initials: S
authors.lastname: Oparil
authors.forename: Michael
authors.initials: M
authors.lastname: Melino
authors.forename: James
authors.initials: J
authors.lastname: Lee
authors.forename: Victor
authors.initials: V
authors.lastname: Fernandez
authors.forename: Reinilde
authors.initials: R
authors.lastname: Heyrman
mesh_terms: D000328:Adult; D000368:Aged; D017311:Amlodipine / Q000009:adverse effects / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D015992:Body Mass Index; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006852:Hydrochlorothiazide / Q000009:adverse effects / Q000627:therapeutic use*; D006973:Hypertension / Q000150:complications / Q000188:drug therapy*; D007093:Imidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000150:complications / Q000188:drug therapy*; D000068557:Olmesartan Medoxomil; D015995:Prevalence; D013777:Tetrazoles / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D007093:Imidazoles; D013777:Tetrazoles; D006852:Hydrochlorothiazide; D017311:Amlodipine; D000068557:Olmesartan Medoxomil
references.citation: Clin Ther. 2010 Jul;32(7):1252-69
references.pmid: 20678674
references.citation: J Am Soc Hypertens. 2010 Jan-Feb;4(1):42-50
references.pmid: 20374950
references.citation: Arch Intern Med. 2002 Sep 9;162(16):1867-72
references.pmid: 12196085
references.citation: JAMA. 2007 Nov 7;298(17):2028-37
references.pmid: 17986696
references.citation: Hypertension. 2003 Dec;42(6):1206-52
references.pmid: 14656957
references.citation: JAMA. 2010 May 26;303(20):2043-50
references.pmid: 20501926
references.citation: Eur Heart J. 2007 Jun;28(12):1462-536
references.pmid: 17562668
references.citation: Circulation. 2011 Aug 30;124(9):1046-58
references.pmid: 21824920
references.citation: JAMA. 2012 Feb 1;307(5):491-7
references.pmid: 22253363
references.citation: Circulation. 1983 May;67(5):968-77
references.pmid: 6219830
references.citation: Obesity (Silver Spring). 2008 Oct;16(10):2323-30
references.pmid: 18719634
references.citation: Circulation. 2013 Jan 1;127(1):143-52
references.pmid: 23283859
references.citation: J Hypertens. 2009 Feb;27(2):207-11
references.pmid: 19155773
references.citation: Am J Cardiol. 2010 Nov 1;106(9):1270-6
references.pmid: 21029823
references.citation: J Am Coll Surg. 2008 Dec;207(6):928-34
references.pmid: 19183541
references.citation: J Clin Hypertens (Greenwich). 2002 Nov-Dec;4(6):393-404
references.pmid: 12461301
references.citation: N Engl J Med. 2008 Dec 4;359(23):2417-28
references.pmid: 19052124
references.citation: Am J Hypertens. 2008 Oct;21(10):1124-8
references.pmid: 18772861
references.citation: Popul Health Manag. 2010 Jun;13(3):151-61
references.pmid: 20521902
references.citation: JAMA. 2003 Apr 23-30;289(16):2073-82
references.pmid: 12709465
references.citation: J Clin Hypertens (Greenwich). 2012 Mar;14(3):149-57
references.pmid: 22372774
references.citation: Hypertension. 2008 Jun;51(6):1403-19
references.pmid: 18391085
references.citation: Circulation. 2011 Mar 1;123(8):933-44
references.pmid: 21262990
references.citation: Lancet. 2004 Jun 19;363(9426):2022-31
references.pmid: 15207952
references.citation: Am J Hypertens. 2004 Oct;17(10):904-10
references.pmid: 15485752
references.citation: J Hypertens. 2004 Apr;22(4):847-57
references.pmid: 15126928
references.citation: Hypertension. 2011 Jun;57(6):1076-80
references.pmid: 21502568
references.citation: J Hypertens. 2003 May;21(5):875-86
references.pmid: 12714861