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Effective Systolic Blood Pressure Reduction with Olmesartan Medoxomil/Amlodipine Combination Therapy

Post Hoc Analysis of Data from a Randomized, Double-Blind, Parallel-Group, Multicentre Study

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Abstract

Background and objective: Systolic blood pressure (SBP) strongly predicts cardiovascular risk and is an important factor to evaluate in studies of anti-hypertensive treatments. A recent randomized controlled study has shown that the angiotensin II type 1 receptor antagonist (angiotensin receptor blocker [ARB]) olmesartan medoxomil (hereafter olmesartan) combined with the calcium channel antagonist (calcium channel blocker) amlodipine can control SBP in a majority of patients with moderate-to-severe hypertension. The aim of this report is to present results from a post hoc analysis of this study to further evaluate the effects of this combination on SBP.

Methods: A post hoc analysis of changes in seated SBP (SeSBP) levels in patients treated with olmesartan 40 mg plus amlodipine 5 or 10 mg was carried out to investigate the distribution of SeSBP changes produced by this combination. Patients who reached the end of the 52-week study were categorized by size of SeSBP reduction from baseline as follows: ≤15 mmHg; s>15 to ≤30 mmHg; s>30 to ≤45 mmHg and s>45 mmHg.

Results: In 578 patients who received olmesartan/amlodipine 40 mg/5 mg or 40 mg/10 mg and completed the study, the mean SeSBP reduction from baseline was 31.18 mmHg, and the proportions of patients with SeSBP reductions ≤15 mmHg, >15 to ≤30 mmHg, >30 to ≤45 mmHg and >45 mmHg were 12.8%, 36.0%, 35.3% and 15.9%, respectively. In patients who received olmesartan/amlodipine 40 mg/10 mg, the proportion of patients in the ≤15 mmHg group was smaller (12.2%) and in the >45 mmHg group was larger (21.6%). Moreover, patients in the >45 mmHg category showed the greatest reduction in SeSBP from baseline (53.5 mmHg for olmesartan/amlodipine 40mg/10mg recipients). Categorical analysis of patients treated with olmesartan/amlodipine 40 mg/10 mg in a separate, factorial study showed similar results: SeSBP reductions of ≤15 mmHg; >15 to ≤30 mmHg; >30 to ≤45 mmHg and >45 mmHg were seen in 17%, 34%, 36% and 14% of patients, respectively.

Conclusion: Treatment with a combination based upon olmesartan 40 mg plus amlodipine 5 or 10 mg effectively reduces elevated SeSBP, particularly in patients with high levels of SeSBP.

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Acknowledgements

This is an analysis of a study sponsored by Daiichi Sankyo Europe GmbH, Munich, Germany. Wolters Kluwer Health provided medical writing assistance in the preparation of this manuscript, which was funded by Daiichi Sankyo Europe. Prof. Mourad has received consulting and/or lecture fees from Daiichi-Sankyo and other companies developing antihypertensive therapies during the last 5 years. Dr Le Jeune has no conflicts of interest that are directly relevant to the content of this study. The authors gratefully acknowledge the assistance of Dr Winfried Koch of HaaPACS GmbH, Schriesheim, Germany with the analysis of data presented in this report.

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  1. Assistance Publique-Hôpitaux de Paris, Avicenne Hospital—Hypertension Unit and University Paris XIII, 125 rue de Stalingrad, 93000, Bobigny cx 09, France

    Jean-Jacques Mourad & Sylvain Le Jeune

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  1. Jean-Jacques Mourad
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  2. Sylvain Le Jeune
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Correspondence to Jean-Jacques Mourad.

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Mourad, JJ., Jeune, S.L. Effective Systolic Blood Pressure Reduction with Olmesartan Medoxomil/Amlodipine Combination Therapy. Clin. Drug Investig. 29, 419–425 (2009). https://doi.org/10.2165/00044011-200929060-00005

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