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

Autor: Cristina Miele, Uwe Haag, Massimo Volpe
Rok vydání: 2009
Předmět:
Zdroj: Clinical drug investigation. 29(6)
ISSN: 1173-2563
Popis: Treatment guidelines recommend combination therapy to control blood pressure (BP) in the majority of hypertensive patients. This long-term open-label study assessed a treatment algorithm based on olmesartan medoxomil (hereafter olmesartan), amlodipine and hydrochlorothiazide (HCTZ).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.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 SBP140 mmHg and DBP90 mmHg for patients without diabetes mellitus, and SBP130 mmHg and DBP80 mmHg for patients with diabetes. Treatment was generally well tolerated, with no unexpected safety concerns.A treatment algorithm based on olmesartan/amlodipine (+/- HCTZ) provides a high degree of BP control in patients with moderate-to-severe hypertension. The open-label study design suggests similar results are obtainable in clinical practice.
Databáze: OpenAIRE