Efficacy of manidipine/delapril versus losartan/hydrochlorothiazide fixed combinations in patients with hypertension and diabetes

Abstract

Background Hypertension markedly increases the already high risk for cardiovascular complications in patients with diabetes mellitus. Less than one in eight patients with hypertension and type 2 diabetes have adequately controlled blood pressure. As a result, antihypertensive combinations are now widely used in management of hypertension associated with diabetes.Methods This double-blind study investigated efficacy of a new fixed dose combination of a calcium antagonist, manidipine 10 mg, and an angiotensin-converting enzyme inhibitor, delapril 30 mg, compared with a combination of an angiotensin receptor blocker, losartan 50 mg, and a diuretic, hydrochlorothiazide 12.5 mg. Patients with hypertension ( blood pressure >= 130/ 80 mmHg) with controlled type 2 diabetes ( HbA1c <= 7.5%) were randomized to manidipine/delapril ( n=153) or losartan/hydrochlorothiazide ( n=161), administered once daily for 12 weeks. Patients underwent ambulatory blood pressure monitor evaluation at baseline and end of treatment.Results Mean decreases in 24- h systolic blood pressure were seen with both manidipine/ delapril ( -9.3mmHg) and losartan/hydrochlorothiazide ( -10.7mmHg) combinations. The mean ( 95% confidence interval) treatment difference was -1.4 ( -4.5/1.8) mmHg, demonstrating noninferiority of the manidipine/ delapril combination. Reduction in 24- h diastolic blood pressure ( -4.6 versus -4.5mmHg) and daytime ( systolic blood pressure -10.5 versus -11.1mmHg) and night-time ( systolic blood pressure -7.1 versus -9.3mmHg) blood pressure were also not significantly different between treatments. Compliance and adverse events were comparable for both groups.Conclusion The study demonstrated that the combination of manidipine and delapril is as effective as losartan and hydrochlorothiazide in treatment of hypertension in type 2 diabetes.