Abstract
Background: It has been demonstrated that L-/N-type calcium channel blocker (CCB), cilnidipine, but not L-type CCB, decreased urinary protein in renin-angiotensin system (RAS) inhibitor-treated hypertensive patients with macroproteinuria. Design and Methods: To clarify whether L-/N-type CCB also has a greater renoprotective effect than L-type CCB in RAS inhibitor-treated hypertensive patients with diabetic microalbuminuria, we conducted a multi-center, open-labeled, randomized trial to compare changes in natural logarithm of albumin/creatinine (Cr) ratio in spot urine between the addition of cilnidipine and amlodipine in RAS inhibitor-treated hypertensive patients with type 2 diabetes and microalbuminuria. Serum Cr, estimated glomerular filtration rate (eGFR), blood pressure (BP) and pulse rate (PR) were also examined. Results: A total of 367 patients were randomly assigned to receive cilnidipine (n = 186) or amlodipine (n = 179) and final doses of cilnidpine and amlodipine were 10.3 ± 4.1 and 4.9 ± 2.1 mg/day, respectively. Both cilnidipine (from 146.6 ± 12.7/81.5 ± 10.3 to 130.4 ± 13.9/73.4 ± 10.2 mmHg) and amlodipine (from 145.4 ± 11.6/80.2 ± 9.8 to 129.7 ± 13.3/71.8 ± 9.8 mmHg) were equally decreased BP and its changes were not different between the two groups. Also, PR was similarly decreased by both drugs. Urinary albumin/Cr ratio was slightly decreased by cilnidipine (from 111.5 ± 139.0 to 107.9 ± 130.2 mg/g) but not by amlodipine (from 88.3 ± 63.5 to 89.1 ± 97.6 mg/g). Changes in natural logarithm of urinary albumin/Cr ratio were not different between the cilnidipine and amlodipine groups. Also, changes in serum Cr and eGFR were not different. Conclusions: The present trials did not demonstrate that cilnidipine has a greater antialbuminuric effect than amlodipine in RAS inhibitor-treated hypertensive patients with type 2 diabetes and microalbuminuria.
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