Efficacy of amlodipine and olmesartan medoxomil in patients with hypertension: the AZOR Trial Evaluating Blood Pressure Reductions and Control (AZTEC) study.
The aim of the present study was to use ambulatory blood pressure (BP) monitoring (ABPM) to determine the efficacy of a fixed-dose combination of amlodipine (AML) and olmesartan medoxomil (OM) over the 24-hour dosing interval. This 12-week, titrate-to-goal study was conducted in 185 patients with hypertension. Patients were initially treated with AML 5 mg/ day and uptitrated to AML/OM 5/20, 5/40, and 10/40 mg/day every 3 weeks if mean seated BP (SeBP) was ≥ 120/80 mmHg. The primary efficacy endpoint was the change from baseline in mean 24-hour systolic BP at week 12 as assessed by ABPM. At baseline, the mean 24-hour ambulatory BP (± standard deviation [SD]) was 144.8 ± 11.1/85.7 ± 7.9 mmHg. At week 12, the change from baseline in mean 24-hour ambulatory BP (± standard error of the mean [SEM]) was -21.4 ± 0.8/-12.7 ± 0.5 mmHg (p < 0.0001 versus baseline). At baseline, the mean SeBP (± SD) was 158.2 ± 12.6/92.8 ± 8.6 mmHg and at week 12, the mean SeBP change (± SEM) from baseline (last observation carried forward) was -24.1 ± 1.1/-12.1 ± 0.7 mmHg (p < 0.0001 versus baseline). Proportions of patients achieving mean 24-hour ambulatory BP prespecified study targets were 70.9% (<130/80 mmHg), 48.3% (<125/75 mmHg), and 40.7% (<120/80 mmHg). Cumulatively, 76.8% of patients uptitrated to AML/OM 10/40 mg/day attained an SeBP goal of <140/90 mmHg. The study drug was well tolerated with few adverse events (peripheral edema, 2.2%; dizziness, 1.1%). An AML/OM-based titration regimen effectively reduces BP in patients with hypertension.