Clin Hypertens.  2018 ;24(1):2. 10.1186/s40885-018-0086-4.

Efficacy and safety of azilsartan medoxomil, an angiotensin receptor blocker, in Korean patients with essential hypertension

• Juhasz A
• Wu J
• Hisada M
• Tsukada T
• Jeong MH

• KMID: 2434256
• DOI: http://doi.org/10.1186/s40885-018-0086-4

Abstract

BACKGROUND
This was a phase 3, randomized, double-blind, placebo-controlled study.
METHODS
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.
RESULTS
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.
CONCLUSIONS
Results of this study confirm a positive benefit-risk profile of AZL-M for essential hypertension in Korean adults. TRIAL REGISTRATION: Clinicaltrial.gov; identifier number: NCT02203916. Registered July 28, 2014 (retrospectively registered) ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s40885-018-0086-4) contains supplementary material, which is available to authorized users.

Keyword

Hypertension; Azilsartan medoxomil; Angiotensin II receptor antagonist; Blood pressure; Korea

MeSH Terms

Adult
Angiotensins*
Blood Pressure
Humans
Hypertension*
Korea
Population Characteristics
Angiotensins