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PLoS One. 2019 Apr 3;14(4):e0214727. doi: 10.1371/journal.pone.0214727. eCollection 2019.

Effects of azilsartan compared with telmisartan on insulin resistance in patients with essential hypertension and type 2 diabetes mellitus: An open-label, randomized clinical trial.

Author information

1
Division of Endocrinology, Metabolism, and Hypertension, Clinical Research Institute for Endocrine and Metabolic Diseases, National Hospital Organization, Kyoto Medical Center, Kyoto, Japan.
2
Japan Medical Affairs, Takeda Pharmaceutical Company Limited, Tokyo, Japan.
3
Department of Endocrinology and Metabolism, Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital, Hiroshima, Japan.
4
Department of Endocrinology and Metabolism, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.
5
Department of Endocrinology and Diabetes, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
6
Data Science Division, Biostatistics Department I, A2 Healthcare Corporation, Tokyo, Japan.

Abstract

BACKGROUND:

Based on non-clinical data, it is expected that azilsartan, an angiotensin II receptor blocker, will help improve insulin resistance in addition to its hypotensive action. The present study is aimed to explore the effect of azilsartan compared to telmisartan on insulin sensitivity in hypertensive patients in the clinical setting.

METHODS:

This multicenter, randomized, open-label, parallel-group exploratory study was conducted in Japan. We randomized adult patients (≥20 years old) with grade I or II essential hypertension and coexisting type 2 diabetes (1:1) to receive either oral azilsartan (20 mg/day;17 patients) or telmisartan (40 mg/day;16 patients) for 12 weeks. The primary endpoint was the change in the homeostasis model assessment ratio of insulin resistance (HOMA-R) from the baseline at the end of the treatment period. We also evaluated its safety and efficacy on other diabetes-related variables and blood pressure.

FINDINGS:

The mean changes in HOMA-R at the end of treatment were 0.22 (95% CI, -1.09-1.52) in the azilsartan group and -0.23 (95% CI, -0.72-0.27) in the telmisartan group. We found no clinically remarkable changes between the groups in diabetes-related variables such as fasting blood glucose, fasting insulin, HbA1c (NGSP), HOMA-β, or 1,5-anhydroglucitol. Reductions in clinic systolic and diastolic blood pressure were observed at week 4 and the reduced levels were maintained throughout the treatment period in both groups. No serious treatment-emergent adverse events (TEAEs) were observed. Only one drug-related TEAE (mild decrease in blood pressure) was reported in one patient in the azilsartan group.

CONCLUSION:

Neither azilsartan nor telmisartan had any clinically remarkable effects on insulin resistance parameters when administered for 12 weeks to patients with grade I or II essential hypertension and coexisting type 2 diabetes mellitus. Azilsartan (20 mg/day) and telmisartan (40 mg/day) exerted comparable antihypertensive effects.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT02079805.

Conflict of interest statement

The authors have read the journal policy and the authors of this manuscript have the following competing interests: MN, RS, and YY declare no competing interests. YK is an employee of the funder, Takeda Pharmaceutical Company Limited. NK reports fees for lecturing from Takeda Pharmaceutical, Astellas, MSD, Ono Pharmaceutical, Kissei Pharmaceutical, Kyowa Hakko Kirin, Kowa, Sanofi, Daiichi-Sankyo, Taisho Toyama Pharmaceutical, Sumitomo Dainippon Pharma, Mitsubishi Tanabe Pharma, Terumo, Eli Lilly Japan, Boehringer Ingelheim Japan, Novartis and Novo Nordisk Pharma. NK also reports a grant from Astellas as a principle investigator of a collaborative clinical study. MA is an employee of A2 Healthcare Corporation. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

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