Indapamide SR was equivalent to enalapril in reducing microalbuminuria (equivalence ratio 1.08; 95% CI 0.89-1.31; P=0.01) in patients with hypertension and type 2 diabetes.
RCT (n=570)
double-blind, double-dummy
randomized
Yes
Does indapamide SR reduce microalbuminuria equivalently to enalapril in hypertensive patients with type 2 diabetes?
Indapamide SR is equivalent to enalapril in reducing microalbuminuria and effectively lowering blood pressure in patients with hypertension and type 2 diabetes.
Effect estimate: Equivalence 1.08 (95% CI 0.89 to 1.31)
Absolute Event Rate: 35% vs 39%
p-value: p=0.01
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.
Marre et al. (Thu,) conducted a rct in type 2 diabetes, essential hypertension, and persistent microalbuminuria (n=570). indapamide SR vs. enalapril 10 mg once a day was evaluated on reduction in the urinary albumin : creatinine ratio (Equivalence 1.08, 95% CI 0.89 to 1.31, p=0.01). Indapamide SR was equivalent to enalapril in reducing microalbuminuria (equivalence ratio 1.08; 95% CI 0.89-1.31; P=0.01) in patients with hypertension and type 2 diabetes.