Key result
Azilsartan did not significantly improve insulin resistance compared to telmisartan (HOMA-IR mean difference 0.3) after 12 weeks of therapy in patients with hypertension and type 2 diabetes mellitus.
Why the study?
Interplay between the autonomic nervous system, RAAS, and immunity contributes to hypertension in diabetes, motivating a comparison of azilsartan and telmisartan effects on insulin resistance and metabolic biomarkers.
Does azilsartan improve insulin resistance and metabolic biomarkers compared to telmisartan in patients with essential hypertension and type 2 diabetes mellitus?
RCT (n=50)
Open-label
Simple randomization
No
Does azilsartan improve insulin resistance and metabolic biomarkers compared to telmisartan in patients with essential hypertension and type 2 diabetes mellitus?
Mean Difference: 0.3 (95% CI -0.87–1.48)
Absolute Event Rate: 0.15% vs 0.32%
p-value: p=0.60
In patients with essential hypertension and type 2 diabetes mellitus, azilsartan and telmisartan provided comparable blood pressure reduction but neither significantly improved insulin resistance or metabolic biomarkers over a 12-week period.
No metabolic advantage for azilsartan over telmisartan in hypertensive T2DM; confirms neither ARB improves insulin resistance over 12 weeks.
Introduction The complex interplay between the autonomic nervous system, renin-angiotensin-aldosterone system (RAAS), and immunity contributes to the pathogenesis of hypertension in diabetes mellitus. The objective of this study was to investigate and compare the effect of azilsartan and telmisartan on insulin resistance and metabolic biomarkers in patients with both hypertension and type 2 diabetes mellitus. Methods The present study was a prospective, randomized, active-controlled, open-label, parallel-group clinical trial. Patients with grade I or II essential hypertension with type 2 diabetes mellitus were randomized into two groups of 25 patients each. Baseline evaluation of homeostasis model assessment-insulin resistance (HOMA-IR), plasma glucose, insulin, leptin and adiponectin levels, and systolic and diastolic blood pressure (SBP and DBP) of patients was done. Patients were reassessed after 12 weeks of drug therapy with azilsartan 40 mg OD (once daily) or telmisartan 40 mg OD. Results The mean changes in HOMA-IR from the baseline at the end of 12 weeks of treatment were 0.15 (-0.64, 0.94.52) in the azilsartan group and 0.32 (-0.61, 1.26) in the telmisartan group. The mean difference in the changes from the baseline in HOMA-IR between the two groups was 0.3 (-0.87, 1.48), which was not statistically significant. No statistically significant changes were observed between the two groups in metabolic biomarkers (leptin: -0.84, CI: -4.83 to 3.14, and adiponectin: -0.12, CI: -0.62 to 0.37). Systolic (SBP) and diastolic blood pressure (DBP) decreased at the end of the 12-week treatment in both the groups; however, there was no significant difference between the two groups (SBP: -2.6, CI: -10.35 to 5.1, and DBP: -3.0, CI: -7.7 to 1.7). Conclusion Neither azilsartan nor telmisartan had any significant effects on insulin resistance and metabolic biomarkers after 12 weeks of drug therapy in hypertension patients associated with type 2 diabetes mellitus. However, they showed a comparable antihypertensive effect. The adverse effects observed were mild in nature, and their incidence was comparable between the two groups.
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Meher et al. (2022) conducted an RCT in Essential hypertension associated with type 2 diabetes mellitus (n=50). Azilsartan vs. Telmisartan 40 mg OD was evaluated on Change in HOMA-IR value from baseline to 12 weeks (MD 0.3, 95% CI -0.87 to 1.48, p=0.60). Azilsartan did not significantly improve insulin resistance compared to telmisartan (HOMA-IR mean difference 0.3) after 12 weeks of therapy in patients with hypertension and type 2 diabetes mellitus.
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