A Clinical Study to Compare the Anti Hypertensive Benefits of Cilnidipine, Azilsartan in Type 2 DM Patients

Abstract

Background: Hypertension accompanies type 2 diabetes mellitus increasing cardiovascular and renal risk and creating a need for effective, well-tolerated antihypertensive therapy. This study compared the short-term effects of cilnidipine and azilsartan in adults with T2DM and newly diagnosed hypertension. Methodology: In this open label randomized control trial, 61 subjects were administered Azilsartan 40mg once daily (n=30) and Cilnidipine 5mg once daily (n=31) for 3 months. The effects on blood pressure, glycemic parameters, lipid profile, high sensitivity C Reactive Protein (hs-CRP), renal parameters, Body Mass Index and quality of life parameters were evaluated. Results: Significant decreases in both systolic and diastolic blood pressure were achieved in both groups with no significant difference between groups in terms of post-treatment blood pressure. Blood glucose, both fasting and postprandial was improved in both groups. Significant improvements in total cholesterol, triglyceride and high-sensitivity CRP levels were observed in azilsartan group with no significant differences between groups in terms of these parameters. Both groups experienced a decrease in serum creatinine and an increase in eGFR with no significant between-group differences in eGFR. Body weight and BMI were essentially unchanged. Conclusion: Both azilsartan and cilnidipine proved to be beneficial for achieving good BP control in T2DM patients with new onset hypertension. The results suggest that cilnidipine can be a valuable choice for antihypertensive treatment of patients, further validation of metabolic and renal effects of cilnidipine is needed. Future large-scale studies are necessary to reveal comparative efficacy and protective effects of the drug.