Olmesartan/Amlodipine/Hydrochlorothiazide in Obese Participants With Hypertension: A TRINITY Subanalysis
Article first published online: 4 JUN 2013
© 2013 Wiley Periodicals, Inc.
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
The Journal of Clinical Hypertension
Volume 15, Issue 8, pages 584–592, August 2013
How to Cite
J Clin Hypertens (Greenwich). 2013;15:584–592. ©2013 Wiley Periodicals, Inc.
- Issue published online: 24 JUL 2013
- Article first published online: 4 JUN 2013
- Manuscript Accepted: 19 APR 2013
- Manuscript Revised: 12 APR 2013
- Manuscript Received: 19 FEB 2013
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/m2) and nonobese (BMI <30 kg/m2) 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/m2. Irrespective of BMI, triple-combination treatment resulted in greater LS mean reductions in seated BP (SeBP) (≥30 kg/m2, 6.7–10.5/4.5–7.3 mm Hg; <30 kg/m2, 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/m2, 62% vs 31%–46% [P<.0001]; <30 kg/m2, 69% vs 41%–55% [P<.005]) at week 12. SeBP reduction and goal attainment (≥30 kg/m2, 63%; <30 kg/m2, 67%) was maintained through week 52/early termination. Triple-combination treatment was well tolerated in both BMI subgroups.