Olmesartan/Amlodipine/Hydrochlorothiazide in Obese Participants With Hypertension: A TRINITY Subanalysis

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.