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Use of Enalapril To Attenuate Decline in Renal Function in Normotensive, Normoalbuminuric Patients with Type 2 Diabetes Mellitus: A Randomized, Controlled Trial

Mordchai Ravid, MD; David Brosh, MD; Zohar Levi, MD; Yosefa Bar-Dayan, MD; Dorit Ravid, MD; and Rita Rachmani, MD
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From Tel-Aviv University and Meir Hospital, Kfar-Sava, Israel. Acknowledgment: The authors thank Professor Lily Neuman from the Department of Epidemiology and Biostatistics, Faculty of Medicine, Ben-Gurion University Beer-Sheva, for guidance in statistical analysis. Grant Support: In part by a 1994 Yehudith and Avi Tyomkin research grant. Requests for Reprints: Mordchai Ravid, MD, Meir Hospital, Kfar-Sava 44281, Israel; e-mail: mravid@netvision.net.il. Current Author Addresses: Dr. M. Ravid: Meir Hospital, Kfar-Sava 44281, Israel.

Copyright ©2004 by the American College of Physicians

Ann Intern Med. 1998;128(12_Part_1):982-988. doi:10.7326/0003-4819-128-12_Part_1-199806150-00004
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Background: Angiotensin-converting enzyme (ACE) inhibitors attenuate the decline in renal function in diabetic patients with microalbuminuria. However, no data are available on the use of ACE inhibitors to prevent the decrease in renal function in normotensive, normoalbuminuric patients with type 2 diabetes.

Objective: To evaluate the effect of prolonged ACE inhibition on renal function and albuminuria in patients with type 2 diabetes.

Design: Randomized, double-blind, placebo-controlled trial with 6-year follow-up.

Setting: Eight outpatient clinics coordinated by a department of medicine in a university hospital.

Patients: 156 patients in whom type 2 diabetes was diagnosed after 40 years of age who had a baseline mean blood pressure less than 107 mm Hg and albuminuria (albumin excretion ≤ 30 mg/24 h).

Intervention: Enalapril, 10 mg/d, or placebo.

Measurements: Degree of albuminuria at 24 hours, creatinine clearance, blood pressure, and hemoglobin A1C values.

Results: Enalapril therapy decreased albumin excretion from a mean ±SD of 11.6 ± 7 mg/24 h to 9.7 ± 6 mg/24 h at 2 years. This was followed by a gradual increase to 15.8 ± 8 mg/24 h at 6 years. In the placebo group, albumin excretion increased from 10.8 ± 8 mg/24 h to 26.5 ± 10 mg/24 h at 6 years (P = 0.001 for enalapril compared with placebo). Transition to microalbuminuria occurred in 15 of 79 (19%) placebo recipients and 5 of 77 (6.5%) enalapril recipients. Enalapril treatment resulted in an absolute risk reduction of 12.5% (95% CI, 2% to 23%; P = 0.042) for development of microalbuminuria. After 6 years, creatinine clearance decreased from 1.78 ± 0.13 mL/s to 1.63 ± 0.12 mL/s (mean decrease, 0.025 mL/s per year) in enalapril recipients and from 1.81 ± 0.15 mL/s to 1.57 ± 0.17 mL/s (mean decrease, 0.04 mL/s per year) in placebo recipients (P = 0.040). Hemoglobin A1C values decreased modestly in both groups. Mean blood pressure remained normal (<107 mm Hg) in all patients.

Conclusions: Enalapril attenuated the decline in renal function and reduced the extent of albuminuria in normotensive, normoalbuminuric patients with type 2 diabetes. Further research is needed to determine whether this treatment forestalls the development of overt nephropathy.


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Figure 1.
Flow of participants through the trial.
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Figure 2.
Creatinine clearance, albumin excretion, and mean blood pressure in normotensive, normoalbuminuric patients with type 2 diabetes who received enalapril (dashed lines) or placebo (solid lines).PP

Each value represents the annual group mean based on two to three measurements per patient. The decrease in creatinine clearance was more pronounced in the placebo group ( = 0.047 for the fifth year and 0.042 for the sixth year). Patients who received enalapril had a lesser degree of albuminuria ( = 0.001).

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