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Olmesartan Medoxomil/Amlodipine/Hydrochlorothiazide

Fixed-Dose Combination in Hypertension

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Abstract

The antihypertensive agents olmesartan medoxomil, amlodipine and hydrochlorothiazide (HCTZ) are now available as a fixed-dose combination tablet (olmesartan medoxomil/amlodipine/HCTZ).

In a 12-week, randomized, double-blind, multi-centre trial (TRINITY) in adults with moderate to severe hypertension, olmesartan medoxomil + amlodipine + HCTZ triple combination therapy produced significantly greater least squares mean reductions from baseline in seated diastolic blood pressure (BP) [primary endpoint] and seated systolic BP than olmesartan medoxomil/amlodipine, olmesartan medoxomil/HCTZ or amlodipine + HCTZ.

Furthermore, significantly more patients achieved BP goals and targets with the triple combination regimen than with any of the dual combination regimens at week 12, with olmesartan medoxomil + amlodipine + HCTZ also demonstrating benefit over the dual regimens in terms of ambulatory BP control.

According to subgroup analyses of the TRINITY trial, olmesartan medoxomil + amlodipine + HCTZ was more effective in reducing BP and achieving BP goals than each of the dual therapies, irrespective of hypertension severity, age, sex, race or diabetes mellitus status.

Data from a number of smaller clinical studies indicated that olmesartan medoxomil + amlodipine+ HCTZ triple combination therapy provides antihypertensive efficacy in patients whose BP is not adequately controlled with olmesartan medoxomil + amlodipine.

Olmesartan medoxomil + amlodipine + HCTZ was generally well tolerated in the TRINITY study, with adverse events usually being mild or moderate in severity.

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Acknowledgements and Disclosures

The manuscript was reviewed by: H.R. Brunner, University of Lausanne, Lausanne, Switzerland; M. Volpe, Division of Cardiology, Faculty of Medicine, Sapienza University of Rome, Sant’Andrea Hospital, Rome, Italy.

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered the opportunity to comment on this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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Correspondence to Emma D. Deeks.

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Deeks, E.D. Olmesartan Medoxomil/Amlodipine/Hydrochlorothiazide. Drugs 71, 209–220 (2011). https://doi.org/10.2165/11206770-000000000-00000

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