Efficacy and safety of azilsartan medoxomil in patients with essential hypertension


eMediNexus    19 February 2018

A phase 3, randomized, double-blind, placebo-controlled study, published recently in Clinical Hypertension, randomized adult patients with essential hypertension and baseline mean sitting clinic systolic blood pressure (scSBP) ≥150 and ≤180 mmHg to 6-week treatment with placebo (n = 65), azilsartan medoxomil (AZL-M) 40 mg (n = 132), or AZL-M 80 mg (n = 131). The primary endpoint was change from baseline to week 6 in trough scSBP.

The least-squares mean (standard error) change in trough scSBP at week 6 were - 8.8 (2.00), - 22.1 (1.41), and - 23.7 (1.40) mmHg, in the placebo, AZL-M 40-mg, and 80-mg groups, respectively. Treatments were well tolerated and adverse events were similar between groups.

A positive benefit-risk profile of AZL-M was thus evident in this study for essential hypertension in adults.

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