Efficacy and Tolerability of Olmesartan Medoxomil Combined with Amlodipine in Patients with Moderate to Severe Hypertension after Amlodipine Monotherapy A Randomized, Double-Blind, Parallel-Group,Multicentre Study

摘要

Background and objectives: Cerebrovascular and cardiac adverse events can be significantly reduced by effective antihypertensive therapy; however, BP control rates remain poor. The objective of this randomized, double-blind, parallel-group, multicentre study was to determine the efficacy and safety of olmesartan medox-omil/amlodipine combination therapy in patients with moderate to severe hypertension who had failed to respond to treatment with 8 weeks of open-label amlodipine.Methods: A total of 1017 patients entered the open-label amlodipine monotherapy stage; mean BP at week 0 was 164/102 mmHg. After 8 weeks of amlodipine monotherapy (5 mg/day), non-responding patients (n = 755) were randomized to receive placebo plus amlodipine 5 mg or a combination of olmesartan medoxomil (10-40 mg) with amlodipine 5 mg for 8 weeks. At week 16, patients who had achieved diastolic BP (DBP) <90 mmHg and/or systolic BP (SBP) <140 mmHg continued on randomized treatment for a further 8 weeks. Patients in whom both SBP and DBP were >140/90 mmHg at week 16 had their medication uptitrated to olmesartan medoxomil/amlodipine 20/5 mg, olmesartan medoxomil/amlodipine 40/5 mg or olmesartan medoxomil/amlodipine 40/10 mg.Results: Combination of olmesartan medoxomil (10-40 mg) with amlodipine 5 mg for 8 weeks (double-blind) reduced mean SBP/DBP by up to 16.8 mmHg and 9.6 mmHg, respectively.