Why the study?
Does azilsartan medoxomil reduce sitting clinic systolic blood pressure in adult Korean patients with essential hypertension?
Does azilsartan medoxomil reduce sitting clinic systolic blood pressure in adult Korean patients with essential hypertension?
Azilsartan medoxomil at 40 mg and 80 mg doses significantly reduces clinic systolic and diastolic blood pressure compared to placebo in Korean patients with essential hypertension.
Supports azilsartan medoxomil for hypertension in Korean adults; extends efficacy data to this population.
This was a phase 3, randomized, double-blind, placebo-controlled study. Adult Korean patients with essential hypertension and a baseline mean sitting clinic systolic blood pressure (scSBP) ≥150 and ≤180 mmHg were randomized 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 the change from baseline to week 6 in trough scSBP. The least-squares mean (standard error) change from baseline in trough scSBP in the placebo, AZL-M 40-mg, and 80-mg groups at week 6 were − 8.8 (2.00), − 22.1 (1.41), and − 23.7 (1.40) mmHg, respectively (p < 0.001 for AZL-M 40 and 80 mg vs placebo). No clinically meaningful heterogeneity in efficacy was observed between subgroups (age, sex, diabetes status) and the overall population. Treatments were well tolerated and adverse events were similar between groups. Results of this study confirm a positive benefit-risk profile of AZL-M for essential hypertension in Korean adults. Clinicaltrial.gov; identifier number: NCT02203916 . Registered July 28, 2014 (retrospectively registered)
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Juhász et al. (2018) studied this question.
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