Clinical Drug Investigation

, Volume 29, Issue 6, pp 381–391

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


    • Second Faculty of MedicineUniversity of Rome ‘La Sapienza’ - Sant’Andrea Hospital
    • IRCCS Neuromed
  • Cristina Miele
    • Specialty School of Cardiology, University of Rome ‘La Sapienza’
  • Uwe Haag
    • HaaPACS GmbH
Original Research Article

DOI: 10.2165/00044011-200929060-00002

Cite this article as:
Volpe, M., Miele, C. & Haag, U. Clin. Drug Investig. (2009) 29: 381. doi:10.2165/00044011-200929060-00002


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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