Abstract
BackgroundBased 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.MethodsThis 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.FindingsThe 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.ConclusionNeither 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 registrationClinicalTrials.gov NCT02079805
Highlights
The Guidelines for the Management of Hypertension issued by the Japanese Society of Hypertension state that hypertension and type 2 diabetes mellitus are primary risk factors for major vascular disorders caused by endothelial dysfunction, atherothrombosis, and so on [1]
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
Since the incidence of cerebrovascular disease and/or ischemic heart disease increases in the concurrent presence of hypertension and type 2 diabetes mellitus, strict management of blood pressure and blood glucose levels is recommended in hypertensive patients with type 2 diabetes mellitus [1, 2]
Summary
The Guidelines for the Management of Hypertension issued by the Japanese Society of Hypertension state that hypertension and type 2 diabetes mellitus are primary risk factors for major vascular disorders caused by endothelial dysfunction, atherothrombosis, and so on [1]. Hypertension and type 2 diabetes mellitus represent components of metabolic syndrome, a disorder based on insulin resistance [2, 3]. The Guidelines for the Management of Hypertension recommend angiotensin II receptor blockers (ARBs) and angiotensin converting enzyme (ACE) inhibitors, which have been shown to improve insulin sensitivity, as the first-line drugs for patients with concurrent hypertension and type 2 diabetes mellitus without adversely affecting lipid metabolism [1]. Telmisartan, an ARB with strong antihypertensive efficacy, has been shown to activate peroxisome proliferator-activated receptor γ (PPARγ) in non-clinical studies and to improve diabetes-related indices, including insulin resistance, in hypertensive patients with type 2 diabetes mellitus [3,4,5,6,7,8,9,10]. The present study is aimed to explore the effect of azilsartan compared to telmisartan on insulin sensitivity in hypertensive patients in the clinical setting
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