Hopital Bichat， Service de Diabetologie et d"Endocrinologie， Paris， France. michel.marre@bch.ap-hop-paris.fr
OBJECTIVES: To test whether microalbuminuria in patients with type 2 diabetes 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 [the diuretic， indapamide sustained release (SR)， and an angiotensin-converting enzyme inhibitor， enalapril] in reducing microalbuminuria.
DESIGN: A multinational， multicentre， controlled， double-blind， double-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) with type 2 diabetes， essential hypertension [systolic blood pressure (SBP) 140-180 mmHg， and diastolic blood pressure (DBP) < 110 mmHg]， and persistent microalbuminuria (20-200 microg/min) were allocated randomly to groups to receive indapamide SR 1.5 mg (n = 284) or enalapril 10 mg (n = 286) once a day. Amlodipine， atenolol， 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 : creatinine ratio. Mean reductions were 35% [95% confidence interval (CI) 24 to 43] and 39% (95% CI 30 to 47%) in the indapamide SR and enalapril groups， respectively. Equivalence was demonstrated between the two groups [1.08 (95% CI 0.89 to 1.31%); P = 0.01]. 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 therapy， with no differences between groups. Both treatments were well tolerated.
CONCLUSIONS: Indapamide-SR-based therapy is equivalent to enalapril-based therapy in reducing microalbuminuria with effective blood pressure reduction in patients with hypertension and type 2 diabetes