Long-term effects of amlodipine versus fosinopril on microalbuminuria in elderly hypertensive patients with type 2 diabetes mellitus

Objective: The aim of this study was to compare the effects on urinary albumin excretion (UAE) of amlodipine versus fosinopril in elderly hypertensive patients with type 2 diabetes mellitus. Methods: We studied 147 elderly (60 to 75 years) hypertensive patients (diastolic blood pressure > 90 mm Hg) with concomitant, well-controlled type 2 diabetes mellitus. After a 4- week placebo period (at the beginning of which current antihypertensive agents were discontinued), they were randomly allocated to receive amlodipine 5 to 10 mg once daily (n = 73) or fosinopril 10 to 20 mg once dally (n = 74) for 24 months. Nonresponders to monotherapy were discontinued after 8 weeks. At the end of the placebo period and after 3, 6, 12, 18, and 24 months of treatment, blood pressure (BP), glycosylated hemoglobin A(1c), UAE, and creatinine clearance were determined. Results: Seventy-nine patients completed the 24-month study. Both amlodipine and fosinoprll similarly reduced BP without affecting glucose homeostasis. At 3 months, UAE was significantly reduced (P <0.01) only in the fosinopril-treated patients; however, at 12 and 24 months, it was significantly decreased with both drugs (fosinopril, P <0.01; amlodipine, P <0.05). Creatinine clearance was unaffected by fosinopril but was significantly increased (P <0.05) by amlodipine at 12 months. Conclusions: Based on these results, we concluded that long-term treatment with both amlodipine and fosinopril was effective in reducing UAE in elderly hypertensive patients with type 2 diabetes mellitus and microalbuminuria.