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Triple-Combination Treatment with Olmesartan Medoxomil/ Amlodipine/ Hydrochlorothiazide in Hispanic/Latino Patients with Hypertension: The TRINITY Study

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TLDR
The efficacy of triple-drug therapy in achieving BP goal was sustained long-term (40-week open-label extension period) in Hispanic/Latino and non-Hispanic/ Latino participants.
Abstract
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 OM40/AML 10/HCTZ 12.5mg or OM 40/AML 5/HCTZ 25mg, then to OM40/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. (Ethn Dis. 2014;24[1]:41–47)

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References
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Fixed-Dose Combinations Improve Medication Compliance: A Meta-Analysis

TL;DR: Fixed-dose combination decreases the risk of medication non-compliance and should be considered in patients with chronic conditions like hypertension for improving medication compliance which can translate into better clinical outcomes.
Journal ArticleDOI

Compliance, Safety, and Effectiveness of Fixed-Dose Combinations of Antihypertensive Agents. A Meta-Analysis

TL;DR: Compared with free-drug combinations, FDCs of antihypertensive agents are associated with a significant improvement in compliance and with nonsignificant beneficial trends in BP and adverse effects.
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Therapeutic Inertia Is an Impediment to Achieving the Healthy People 2010 Blood Pressure Control Goals

TL;DR: Therapeutic inertia (TI), defined as the providers’ failure to increase therapy when treatment goals are unmet, contributes to the high prevalence of uncontrolled hypertension, but the quantitative impact is unknown.
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