Antihypertensive efficacy of the angiotensin receptor blocker azilsartan medoxomil compared with the angiotensin-converting enzyme inhibitor ramipril

Abstract

Drug therapy often fails to control hypertension. Azilsartan medoxomil (AZL-M) is a newly developed angiotensin II receptor blocker with high efficacy and good tolerability. This double-blind, controlled, randomised trial compared its antihypertensive efficacy and safety vs the angiotensin-converting enzyme inhibitor ramipril (RAM) in patients with clinic systolic blood pressure (SBP) 150-180 mm Hg. Patients were randomised (n=884) to 20 mg AZL-M or 2.5 mg RAM once daily for 2 weeks, then force-titrated to 40 or 80 mg AZL-M or 10 mg RAM for 22 weeks. The primary endpoint was change in trough, seated, clinic SBP. Mean patient age was 57±11 years, 52.4% were male, 99.5% were Caucasian. Mean baseline BP was 161.1±7.9/94.9±9.0 mm Hg. Clinic SBP decreased by 20.6±0.95 and 21.2±0.95 mm Hg with AZL-M 40 and 80 mg vs12.2±0.95 mm Hg with RAM (P<0.001 for both AZL-M doses). Adverse events leading to discontinuation were less frequent with AZL-M 40 and 80 mg (2.4% and 3.1%, respectively) than with RAM (4.8%). These data demonstrated that treatment of stage 1-2 hypertension with AZL-M was more effective than RAM and better tolerated.

Figure 1

Changes in clinic (a) SBP and (b) DBP over time. The differences between the two AZL-M groups and the RAM group at week 24 were highly significant for both SBP and DBP (P<0.001).

Figure 2

Hourly SBP at (a) baseline and (b) after 24 weeks of treatment with AZL-M 40 or 80 mg or RAM 10 mg.

Figure 3

Open circles are seated, clinic SBP treatment differences between the group that received AZL-M 40 mg and the RAM group. Closed circles are the treatment differences between the AZL-M 80 mg group and the RAM group. The median clinic SBP at baseline was 160.3 mm Hg. Baseline estimated glomerular filtration rate (eGFR) categories expressed as ml min⁻¹ per 1.73 m². *P<0.05 vs RAM. BMI, body mass index.