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Combination Therapy with Olmesartan Medoxomil and Hydrochlorothiazide

Secondary Analysis of the Proportion of Patients Achieving Recommended Blood Pressure Goals from a Randomized, Double-Blind, Factorial Study

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Abstract

Background

The combination of olmesartan medoxomil and hydrochlorothiazide (HCTZ) [olmesartan medoxomil/HCTZ] has previously been shown to produce significantly greater SBP/DBP reductions than monotherapy with either agent alone in a randomized, double-blind, factorial study in patients with stage 2 hypertension. Compared with the evaluation of a single mean BP reduction in a patient population, determining the efficacy of an antihypertensive agent in achieving multiple BP targets provides additional information about the range of BP reductions attainable within this study population.

Objective

To conduct a secondary analysis of this study to evaluate the proportion of patients achieving combined SBP/DBP targets recommended in current hypertension treatment guidelines as well as individual SBP and DBP targets.

Methods

A total of 502 patients with DBP ≥100 and ≤115 mmHg were randomized to 8 weeks of treatment with placebo, HCTZ 12.5 or 25 mg/day, olmesartan medoxomil 10, 20, or 40 mg/day, or olmesartan medoxomil/HCTZ 10/12.5, 10/25, 20/12.5, 20/25, 40/12.5, or 40/25 mg/day. Mean baseline SBP ranged from 151.9 to 156.6 mmHg and mean baseline DBP ranged from 102.6 to 104.4 mmHg across the twelve treatment arms. The chi-squared test was used to compare the proportion of patients achieving each BP goal in each of the 11 active treatment regimens with that in the placebo group.

Results

The proportion of patients achieving an SBP <140 or <130 mmHg, DBP <90, <85, or <80 mmHg and combined SBP/DBP <140/90, <130/85, <130/80, or <120/80 mmHg typically increased with escalating dosages of olmesartan medoxomil and HCTZ when administered alone or in combination, but was always highest in those treated with the combination. As the BP goal became progressively more stringent, the proportion of patients achieving the BP goal decreased in each treatment group, although the trend toward greater reductions in patients treated with combination therapy remained intact. All combined SBP/DBP goals were achieved by a statistically significant proportion of patients (p<0.05) in the olmesartan medoxomil/HCTZ 20/25, 40/12.5, and 40/25 treatment groups.

Conclusions

A majority of patients with uncomplicated stage 2 hypertension can achieve recommended BP goals when treated with the combination of olmesartan medoxomil and HCTZ.

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Acknowledgments

This study was sponsored and funded by Daiichi Sankyo, Inc., Parsippany, New Jersey, USA. Dr Chrysant has received research grants, consultation fees, and honoraria from Daiichi Sankyo, Inc. Kathleen J. Chavanu, PharmD, is an employee of Daiichi Sankyo, Inc. Jianbo Xu was a full time consultant for Daiichi Sankyo, Inc. during the time of manuscript development. Editorial assistance was provided by Karen Stauffer, PhD, Alan J. Klopp, PhD, of Wolters Kluwer Health Medical Communications and Blair Jarvis, MSc., who worked on behalf of Wolters Kluwer Health Medical Communications.

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Authors and Affiliations

  1. Oklahoma Cardiovascular and Hypertension Center and the University of Oklahoma, School of Medicine, 5850 W. Wilshire Boulevard, Oklahoma City, Oklahoma, OK 73132, USA

    Steven G. Chrysant (Clinical Professor of Medicine)

  2. Daiichi Sankyo, Inc., Parsippany, New Jersey, USA

    Kathleen J. Chavanu & Jianbo Xu

Authors
  1. Steven G. Chrysant
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  2. Kathleen J. Chavanu
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  3. Jianbo Xu
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Correspondence to Steven G. Chrysant.

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Chrysant, S.G., Chavanu, K.J. & Xu, J. Combination Therapy with Olmesartan Medoxomil and Hydrochlorothiazide. Am J Cardiovasc Drugs 9, 241–251 (2009). https://doi.org/10.2165/00129784-200909040-00001

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