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Efficacy and Safety of a Stepped-Care Regimen Using Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide in Patients with Moderate-to-Severe Hypertension

An Open-Label, Long-Term Study

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Abstract

Background: Treatment guidelines recommend combination therapy to control blood pressure (BP) in the majority of hypertensive patients. This longterm open-label study assessed a treatment algorithm based on olmesartan medoxomil (hereafter olmesartan), amlodipine and hydrochlorothiazide (HCTZ).

Methods: Patients with moderate-to-severe hypertension who were inadequately controlled with amlodipine 5mg/day monotherapy and who subsequently completed 16 weeks of double-blind combination treatment with olmesartan and amlodipine entered a 28-week open-label phase in which all patients initially received olmesartan/amlodipine 40/5 mg/day. After 4, 10 and 19 weeks, patients with inadequately controlled hypertension (seated trough diastolic [DBP] and systolic [SBP] BP ≥90 mmHg and ≥140 mmHg, respectively) had their doses increased in a step-wise manner to: (i) olmesartan/amlodipine 40/10 mg; (ii) olmesartan/amlodipine/HCTZ 40/10/12.5 mg; and (iii) olmesartan/amlodipine/HCTZ 40/10/25 mg.

Results: In total, 692 patients entered the open-label phase (691 on olmesartan/amlodipine 40/5 mg). The majority of patients remained on olmesartan/amlodipine 40/5 mg without dose elevation, and, of these, 74.3% achieved goal BP at study completion or early termination. Additional patients achieved goal BP with each successive uptitration of therapy: in patients who finished the study on olmesartan/amlodipine 40/10 mg and olmesartan/amlodipine/HCTZ 40/10/12.5 mg, the respective proportions who reached goal BP were 59.0% and 47.1%. Overall, 66.9% of patients achieved the European guideline recommended goal BP of SBP <140 mmHg and DBP <90 mmHg for patients without diabetes mellitus, and SBP <130 mmHg and DBP <80 mmHg for patients with diabetes. Treatment was generally well tolerated, with no unexpected safety concerns.

Conclusions: A treatment algorithm based on olmesartan/amlodipine (± HCTZ) provides a high degree of BP control in patients with moderateto-severe hypertension. The open-label study design suggests similar results are obtainable in clinical practice.

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Acknowledgements

This study was sponsored by Daiichi Sankyo Europe GmbH, Munich, Germany.

The authors would like to thank Dr Peter Brommer of Gemeinschaftspraxis, Tann/Rhön, Germany for assistance in the conduct of this study; Dr Winfried Koch of HaaPACS GmbH, Schriesheim, Germany for assistance with the analysis of data presented in this report; and Jackie Campbell from Wolters Kluwer Health Medical Communications, Chester, UK who provided medical writing support on behalf of Daiichi-Sankyo Europe.

Massimo Volpe has served as a speaker for Daichii Sankyo, Guidotti and Malesci; has served on an International Advisory Board for Daichii Sankyo; and has received a research grant from Pfizer. Cristina Miele has no conflicts of interest to declare. Uwe Haag is a consultant to Daiichi Sankyo.

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Authors and Affiliations

  1. Second Faculty of Medicine, University of Rome ‘La Sapienza’ - Sant’Andrea Hospital, Via di Grottarossa, 1035, Rome, Italy

    Massimo Volpe

  2. IRCCS Neuromed, Pozzilli, Italy

    Massimo Volpe

  3. Specialty School of Cardiology, University of Rome ‘La Sapienza’, Rome, Italy

    Cristina Miele

  4. HaaPACS GmbH, Schriesheim, Germany

    Uwe Haag

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  1. Massimo Volpe
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  2. Cristina Miele
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Correspondence to Massimo Volpe.

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Volpe, M., Miele, C. & Haag, U. Efficacy and Safety of a Stepped-Care Regimen Using Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide in Patients with Moderate-to-Severe Hypertension. Clin. Drug Investig. 29, 381–391 (2009). https://doi.org/10.2165/00044011-200929060-00002

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  • DOI: https://doi.org/10.2165/00044011-200929060-00002

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