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.
Punzi
Henry
H
Trinity Hypertension Research Institute and Metabolic Research Institute, Punzi Medical Center, 1932 Walnut Plaza, Carrollton, TX 75006, USA. punzimedcenter@aol.com
Neutel
Joel M
JM
Kereiakes
Dean J
DJ
Shojaee
Ali
A
Waverczak
William F
WF
Dubiel
Robert
R
Maa
Jen-Fue
JF
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017311:Amlodipine / Q000009:adverse effects / Q000627:therapeutic use*; D047228:Angiotensin II Type 1 Receptor Blockers / Q000009:adverse effects / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects*; D018660:Blood Pressure Monitoring, Ambulatory; D002121:Calcium Channel Blockers / Q000009:adverse effects / Q000627:therapeutic use*; D004338:Drug Combinations; D005260:Female; D006801:Humans; D006973:Hypertension / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D007093:Imidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011446:Prospective Studies; D013777:Tetrazoles / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D014665:Vasodilator Agents / Q000009:adverse effects / Q000627:therapeutic use*
D047228:Angiotensin II Type 1 Receptor Blockers; D000959:Antihypertensive Agents; D002121:Calcium Channel Blockers; D004338:Drug Combinations; D007093:Imidazoles; D013777:Tetrazoles; D014665:Vasodilator Agents; D017311:Amlodipine; C437965:olmesartan