Efficacy of amlodipine and olmesartan medoxomil in patients with hypertension: the AZOR Trial Evaluating Blood Pressure Reductions and Control (AZTEC) study.

Author(s): Punzi H, Neutel JM, Kereiakes DJ, Shojaee A, Waverczak WF, Dubiel R, Maa JF

Affiliation(s): Trinity Hypertension Research Institute and Metabolic Research Institute, Punzi Medical Center, 1932 Walnut Plaza, Carrollton, TX 75006, USA. punzimedcenter@aol.com

Publication date & source: 2010-08, Ther Adv Cardiovasc Dis., 4(4):209-21. Epub 2010 Jun 2.

Publication type: Clinical Trial; Multicenter Study; Research Support, Non-U.S. Gov't

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.