Efficacy and Safety of a Stepped-Care Regimen Using Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide in Patients
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Clin Drug Invest 2009; 29 (6): 381-391 1173-2563/09/0006-0381/$49.95/0
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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 Massimo Volpe,1,2 Cristina Miele3 and Uwe Haag4 1 2 3 4
2nd Faculty of Medicine, University of Rome ‘La Sapienza’ – Sant’Andrea Hospital, Rome, Italy IRCCS Neuromed, Pozzilli, Italy Specialty School of Cardiology, University of Rome ‘La Sapienza’, Rome, Italy HaaPACS GmbH, Schriesheim, Germany
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 5 mg/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
Volpe et al.
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guideline recommended goal BP of SBP
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