Efficacy and safety of long-term treatment with the combination of amlodipine besylate and olmesartan medoxomil in patients with hypertension

Abstract

J Clin Hypertens (Greenwich). 2009;11:475-482. (c) 2009 Wiley Periodicals, Inc.The authors report on the 44-week open-label extension of the 8-week, double-blind Combination of Olmesartan Medoxomil and Amlodipine Besylate in Controlling High Blood Pressure (COACH) trial in 1684 patients. Initial therapy was amlodipine (AML) plus olmesartan medoxomil (OM) 5+40 mg/d, up-titrated to AML+OM 10+40 mg/d plus hydrochlorothiazide (HCTZ) 12.5 mg then 25 mg if patients did not achieve blood pressure (BP) goal (<140/90 mm Hg or <130/80 mm Hg in patients with diabetes). Baseline mean BP decreased from 164/102 mm Hg to 131/82 mm Hg at end of study, with an overall 66.7% of patients, including those with diabetes, achieving BP goal. The BP goal achievement was 80% for AML+OM 5+40 mg/d, 70.6% for AML+OM 10+40 mg/d, 66.6% for AML+OM+HCTZ 10+40+12.5 mg/d, and 46.3% for AML+OM+HCTZ 10+40+25 mg/d. Study medication was safe and well tolerated. Combination antihypertensive therapy with AML+OM+/-HTCZ, up-titrated as necessary, allowed a majority of patients to achieve BP goal.

Trial registration: ClinicalTrials.gov NCT00649389.

Figures

Figure 1

Design of the Combination of Olmesartan Medoxomil and Amlodipine Besylate in Controlling High Blood Pressure (COACH) study. AML indicates amlodipine; BP, blood pressure; HCTZ, hydrochlorothiazide; OLE, open‐label extension; OM, olmesartan medoxomil; SeDBP, seated diastolic BP.

Figure 2

Achievement of blood pressure (BP) goal by treatment regimen. Values represent the percentage of patients achieving the BP treatment goal at the week 52/early termination (ET) time point and “n” represents the number of patients on that regimen at week 52/ET. “All regimens” cohort includes 63 patients who received non–protocol‐specified treatments defined as “other.” The BP goal was <140/90 mm Hg or <130/80 mm Hg for patients with diabetes. AML indicates amlodipine; HCTZ, hydrochlorothiazide; OM, olmesartan medoxomil.

Figure 3

Achievement of blood pressure (BP) targets by treatment regimen. Data represent all patients who were exposed to a particular treatment regimen throughout the duration of the open‐label extension, regardless of whether they remained on the regimen or were titrated to another. All drug concentrations are mg/d. AML indicates amlodipine; HCTZ, hydrochlorothiazide; OM, olmesartan medoxomil.