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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.
PLoS One. 2019; 14(4):e0214727.Plos

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.

Authors+Show Affiliations

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

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

30943275

Citation

Naruse, Mitsuhide, et al. "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." PloS One, vol. 14, no. 4, 2019, pp. e0214727.
Naruse M, Koike Y, Kamei N, et al. 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. PLoS ONE. 2019;14(4):e0214727.
Naruse, M., Koike, Y., Kamei, N., Sakamoto, R., Yambe, Y., & Arimitsu, M. (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. PloS One, 14(4), e0214727. https://doi.org/10.1371/journal.pone.0214727
Naruse M, et al. 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. PLoS ONE. 2019;14(4):e0214727. PubMed PMID: 30943275.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Naruse,Mitsuhide, AU - Koike,Yasuhiro, AU - Kamei,Nozomu, AU - Sakamoto,Ryuichi, AU - Yambe,Yuko, AU - Arimitsu,Michinori, Y1 - 2019/04/03/ PY - 2018/10/17/received PY - 2019/02/26/accepted PY - 2019/4/4/entrez PY - 2019/4/4/pubmed PY - 2020/1/18/medline SP - e0214727 EP - e0214727 JF - PloS one JO - PLoS ONE VL - 14 IS - 4 N2 - 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. SN - 1932-6203 UR - https://www.unboundmedicine.com/medline/citation/30943275/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_ L2 - http://dx.plos.org/10.1371/journal.pone.0214727 DB - PRIME DP - Unbound Medicine ER -