Objectives: To test whether microalbuminuria in patients with type 2 di abetes and hypertension is primarily dependent on the severity of hypertension, and to compare the effectiveness of two antihypertensive drugs with opposite effects on the renin-angiotensin system > in reducing microal buminuria. Design: A multinational, multicentre, controlled, double-blind, doub le-dummy, randomized, two-parallel-groups study over 1 year. Methods: After a 4-week placebo run-in period, 570 patients (ages 60.0 ±9.9 years, 64%men) w ith type 2 diabetes, essential hypertension >, and persistent microal buminuria (20-200 μg/min) were allocated randomly to groups to receive indapam ide SR 1.5 mg (n=284) or enalapril 10 mg (n=286) once a day. Amlodipine, atenolo l, or both were added, if necessary, to achieve the target blood pressure of 140 /85 mmHg. Results: There was a significant reduction in the urinary albumin: cre atinine ratio. Mean reductions were 35%> and 39%(95%CI 30 to 47%) in the indapamide SR and enalapril groups, respectiv ely. Equivalence was demonstrated between the two groups >. The reductions in mean arterial pressure (MAP) were 16.6 ±9.0 mmHg for the indapamide SR group and 15.0 ±9.1 mmHg for the enalapril group (NS ); the reduction in SBP was significantly greater (P =0.0245) with indapamide SR . More than 50%of patients in each group required additional antihypertensive t herapy, with no differences between groups. Both treatments were well tolerated. Conclusions: Indapamide-SR-based therapy is equivalent to enalapril-based th erapy in reducing microalbuminuria with effective blood pressure reduction in pa tients with hypertension and type 2 diabetes.
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