title: Triple-combination treatment with olmesartan medoxomil/amlodipine/ hydrochlorothiazide in Hispanic/Latino patients with hypertension: the TRINITY study.
abstract: OBJECTIVE
  Evaluate efficacy/safety of olmesartan medoxomil (OM)/amlodipine (AML)/ hydrochlorothiazide (HCTZ) in Hispanic/Latino adults with hypertension.
  
  
  METHODS
  Randomized, double-blind, 12-week, parallel-group study followed by a 40-week open-label extension phase.
  
  
  METHODS
  Clinical sites (317) in the United States and Puerto Rico.
  
  
  METHODS
  Individuals > or =18 years of age with mean seated blood pressure (BP) > or =140/100 or > or =160/90 mm Hg divided into Hispanic/Latino (369) and non-Hispanic/Latino (2122) subgroups.
  
  
  METHODS
  Participants were randomized to OM 40/AML 10 mg, OM 40/HCTZ 25 mg, AML 10/HCTZ 25 mg, or OM 40/AML 10/HCTZ 25 mg during the double-blind phase. During the open-label extension, all participants received OM 40/AML 5/HCTZ 12.5 mg; participants not reaching BP goal within 2 weeks were randomly titrated to OM 40/AML 10/HCTZ 12.5 mg or OM 40/AML 5/HCTZ 25 mg, then to OM 40/AML 10/ HCTZ 25 mg after another 2 weeks.
  
  
  METHODS
  Change in mean seated diastolic BP (SeDBP) from baseline (double-blind phase).
  
  
  RESULTS
  Triple-drug therapy vs the dual therapies resulted in greater mean reduction in SeBP (Hispanic/Latino: 35.0/20.9 mm Hg vs 27.8-30.9/15.3-17.7 mm Hg; non-Hispanic/Latino: 39.0/21.7 mm Hg vs 28.9-31.5/14.6-17.8 mm Hg) and enabled more participants to reach BP goal (Hispanic/Latino: 56.8% vs 40.6%-51.2%; non-Hispanic/Latino: 65.7% vs 33.8%-46.6%) irrespective of ethnicity. The efficacy of triple-drug therapy in achieving BP goal was sustained long-term (40-week open-label extension period) in Hispanic/Latino (63.3%) and non-Hispanic/ Latino (64.2%) participants. Triple-drug therapy was well tolerated in Hispanic/Latino and non-Hispanic/Latino participants.
  
  
  CONCLUSIONS
  In this study, OM/AML/HCTZ was an effective treatment option in Hispanic/ Latino patients with hypertension.
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Lewin
authors.forename: Dean J
authors.initials: DJ
authors.lastname: Kereiakes
authors.forename: Steven G
authors.initials: SG
authors.lastname: Chrysant
authors.forename: Joseph L
authors.initials: JL
authors.lastname: Izzo
authors.forename: Suzanne
authors.initials: S
authors.lastname: Oparil
authors.forename: James
authors.initials: J
authors.lastname: Lee
authors.forename: Victor
authors.initials: V
authors.lastname: Fernandez
authors.forename: Michael
authors.initials: M
authors.lastname: Melino
mesh_terms: D000368:Aged; D017311:Amlodipine / Q000008:administration & dosage*; D000959:Antihypertensive Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006630:Hispanic or Latino; D006801:Humans; D006852:Hydrochlorothiazide / Q000008:administration & dosage*; D006973:Hypertension / Q000188:drug therapy* / Q000208:ethnology*; D007093:Imidazoles / Q000008:administration & dosage*; D016018:Least-Squares Analysis; D008297:Male; D008875:Middle Aged; D000068557:Olmesartan Medoxomil; D013777:Tetrazoles / Q000008:administration & dosage*
chemical_list: D000959:Antihypertensive Agents; D007093:Imidazoles; D013777:Tetrazoles; D006852:Hydrochlorothiazide; D017311:Amlodipine; D000068557:Olmesartan Medoxomil