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G-009 EFFICACY AND SAFETY OF TWO FIXED-COMBINATION ANTIHYPERTENSIVE REGIMENS, AMLODIPINE-BENAZEPRIL VERSUS VALSARTAN-HYDROCHLOROTHIAZIDE, IN TYPE 2 DIABETIC PATIENTS WITH HYPERTENSION

Background Fixed-dose combination therapy is a current trend to treat hypertension because of the advantage of pill-loading reduction. In the present study, we examined the blood pressure (BP) lowering and associated metabolic effects of benazepril-amlodopine in comparison to valsartan-hydrochlorothiazide, one of the most utilizing anti-hypertensive drugs, on type 2 diabetic subjects with hypertension. Methods In the randomized, double-blinded and non-inferiority clinical trial, type 2 diabetic subjects with hypertension who had microalbuminuria within one year were randomly assigned to benazepril-amlodopine or valsartan-hydrochlorothiazide treatment for 16 weeks. Results Of total 169 subjects after randomization, 74 of 84 subjects in benazepril-amlodopine group and 78 of 85 subjects in valsartan-hydrochlorothiazide group completed the assessment. We demonstrated a non-inferiority of benazepril-amlodopine in diastolic BP (95% CI = −3.48 to 1.60 mmHg, P = 0.446) as well as systolic BP reduction (95% CI = −1.23 to 5.99 mmHg, P = 0.195). Furthermore, benazepril-amlodopine showed a better outcome with non-decline of estimated glomerular filtration rate (eGFR) (P = 0.003), reduction of glycosylated hemoglobin (HbA1c) (P < 0.001), raised high-density lipoprotein (HDL) cholesterol (P = 0.036) and reduction of triglycerides (P = 0.002) than that in valsartan-hydrochlorothiazide group. There were no significant different in adverse effects between study groups, except higher frequency of respiratory disorders was noted in benazepril-amlodopine group. Conclusion Benazepril-amlodopine showed a non-inferiority effect on BP reduction and more benefits on renal function, glucose control, HDL cholesterol and triglyceride than valsartan-hydrochlorothiazide in type 2 diabetic subjects with hypertension. However, respiratory adverse events, especial cough, were more frequently reported when using benazepril-amlodopine.