Key result
Enalapril reduces nephropathy risk by ~42% over seven years compared to placebo.
Why the study?
The long-term renoprotective effect of angiotensin-converting enzyme inhibition on advanced nephropathy in normotensive patients with non-insulin-dependent diabetes mellitus was not established.
Does enalapril prevent the development of nephropathy in normotensive patients with non-insulin-dependent diabetes mellitus and microalbuminuria?
Comparison
Enalapril 10 mg/day vs placebo for 5 years, followed by optional open-label enalapril or no treatment
Design
Randomized controlled study, double-blinded first phase and open second phase
Follow-up
7 years
Authors
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ACE inhibitors stabilize renal function for 7 years in normotensive type 2 diabetes with microalbuminuria; extends prior short-term RCT data and supports early use.
RCT (n=94)
Double-blinded (first phase) and open (second phase)
randomized
Does enalapril prevent the development of nephropathy in normotensive patients with non-insulin-dependent diabetes mellitus and microalbuminuria?
Absolute Risk Reduction: 42 (95% CI 15–69)
Absolute Risk Reduction: 42%
p-value: p=<.001
Enalapril provides long-term renoprotection and significantly reduces the risk of developing nephropathy in normotensive patients with type 2 diabetes and microalbuminuria.
M. Ravid (1996) conducted an RCT in non-insulin-dependent diabetes mellitus (n=94). enalapril maleate vs. placebo was evaluated on development of nephropathy (ARR 42%, 95% CI 15-69, p=<.001). Enalapril treatment resulted in an absolute risk reduction of 42% for the development of nephropathy over 7 years (95% CI 15-69%; P<0.001).
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