Triple-combination treatment with olmesartan medoxomil/amlodipine/ hydrochlorothiazide in Hispanic/Latino patients with hypertension: the TRINITY study.

Objective(s): Evaluate efficacy/safety of olmesartan medoxomil (OM)/amlodipine (AML)/hydrochlorothiazide (HCTZ) in Hispanic/Latino adults with hypertension. Design: Randomized, double-blind, 12-week, parallel-group study followed by a 40-week open-label extension phase. Setting: Clinical sites (317) in the United States and Puerto Rico. Patients or Participants: Individuals >= 18 years of age with mean seated blood pressure (BP) >= 140/100 or >= 160/90 mm Hg divided into Hispanic/Latino (369) and non-Hispanic/Latino (2122) subgroups. Interventions: 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. Main Outcome Measure: 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.