Q J Med 2001; 94: 89-94
© 2001 Association of Physicians
Randomized placebo-controlled trial of perindopril in normotensive, normoalbuminuric patients with type 1 diabetes mellitus
From the Section of Endocrinology and Nephrology, Department of Internal Medicine, Esbjerg County Hospital, Esbjerg, Denmark
Received 14 January 2000 and in revised form 4 December 2000
Diabetic nephropathy is one of the leading causes of end-stage renal disease. We examined whether ACE inhibitor treatment may have a nephroprotective effect in normotensive insulin-dependent diabetic patients without microalbuminuria and with normal glomerular filtration rate (GFR), and whether any effect was associated with the ACE genotype. In a prospective double-blind randomized study, normotensive patients with type 1 diabetes mellitus with normal serum creatinine and no microalbuminuria were treated with either placebo or perindopril, an ACE inhibitor. Urine albumine/creatinine ratio (ACR), mean blood pressure (MBP) and index of glomerular filtration rate (GFR) based on S-creatinine were determined. ACE genotype was determined by electrophoresis. ACR was higher in the placebo group than in the perindopril group after 4 months, and continued to increase during the study period. After 36 months of observation, ACR in the placebo group was 1.7±1.1 mg/mmol, and 0.6±0.2 mg/mmol in the ACE-inhibitor-treated group (p<0.001, MannWhitney test). During treatment, a significant increase in ACR in the placebo group (p=0.007), Wilcoxon matched paired test) was observed. There were no differences between the groups regarding MBP or GFR. The nephroprotective effects of ACE inhibitor treatment was not associated with the ACE genotype (II, ID, DD).
Address correspondence to Dr J. Kvetny, Section of Endocrinology, Department of Internal Medicine, Esbjerg Centralsygehus, DK-6700 Esbjerg, Denmark. e-mail: jkv{at}ribeamt.dk
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