Effect of lercanidipine compared with ramipril on albumin excretion rate in hypertensive Type 2 diabetic patients with microalbuminuria: DIAL Study (Diabete, Ipertensione, Albuminuria, Lercanidipina)

Abstract

Aim. Microalbuminuria (MAU) and hypertension (AH) are risk factors (RFs) for diabetic nephropathy in patients with Type 2 diabetes mellitus (DM-2). Recent data suggest that blockade of the renin-angiotensin system (RAS) slows the progression of diabetic nephropathy. In contrast, the results on the renoprotective effect of calcium channel antagonists (CAs) are conflicting. We evaluated the effectiveness of lercanidipine, in comparison with ramipril, on the reduction in albumin excretion rate (AER) and blood pressure (BP) in mild-to-moderate hypertensive patients with DM-2 and persistent MAU. Material and methods. A total of 277 patients were enrolled in a multi-centre, randomised, double-blind, activecontrolled, parallel-group trial: 180 were randomised to receive 10-20 mg/d of lercanidipine or 5-10 mg/d of ramipril and followed up for 9-12 months. The primary outcome was the change in AER from baseline. Results. After 9-12 months of follow-up, a reduction in AER of -17,4±65 μg/min (р<0,05) and -19,7±52,5 μg/ min (р<0,05), in the lercanidipine and ramipril group, respectively, was observed, without significant differences between the groups. A significant reduction in systolic and diastolic BP was observed in both the lercanidipine and ramipril-based treatment groups (р<0,0001 for both). Conclusion. Treatment with lercanidipine (10-20 mg/d) does not worsen albuminuria in patients with AH, DM-2, and MAU. Both lercanidipine and ramipril treatments resulted in a significant reduction in AER, without a statistically significant difference between the two groups.

Keywords

• diabetic nephropathy
• microalbuminuria
• lercanidipine
• type 2 diabetes mellitus