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Online Clinical Calculator |
ACEI slows progression of renal
dysfunction (creat 3-5 mg/dL)
|
Clinical Question:
Does benazepril improve renal outcomes for patients with a creatinine level
greater than 3.0 mg/dL?
Bottom Line:
In a group of nondiabetic patients with serum creatinine levels between 3.0
and 5.0 mg/dL, benazepril slows the progression of renal disease. These
patients were carefully monitored for any changes in renal function during
the first 8 weeks, and were carefully screened and monitored to detect any
early adverse effects on renal function.
Reference:
Hou FF, Zhang X, Zhang GH, et al. Efficacy and safety of benazepril for
advanced chronic renal insufficiency. N Engl J Med 2006;354:131-40.
Study Design:
Randomized controlled trial (double-blinded)
Synopsis:
Angiotensin-converting-enzyme inhibitors provide renal protection in
patients with mild-to-moderate renal insufficiency (serum creatinine level,
3.0 mg per deciliter or less). We assessed the efficacy and safety of
benazepril in patients without diabetes who had advanced renal
insufficiency. We enrolled 422 patients in a randomized, double-blind study.
After an eight-week run-in period, 104 patients with serum creatinine levels
of 1.5 to 3.0 mg per deciliter (group 1) received 20 mg of benazepril per
day, whereas 224 patients with serum creatinine levels of 3.1 to 5.0 mg per
deciliter (group 2) were randomly assigned to receive 20 mg of benazepril
per day (112 patients) or placebo (112 patients) and then followed for a
mean of 3.4 years. All patients received conventional antihypertensive
therapy. The primary outcome was the composite of a doubling of the serum
creatinine level, end-stage renal disease, or death. Secondary end points
included changes in the level of proteinuria and the rate of progression of
renal disease. Of 102 patients in group 1, 22 (22 percent) reached the
primary end point, as compared with 44 of 108 patients given benazepril in
group 2 (41 percent) and 65 of 107 patients given placebo in group 2 (60
percent). As compared with placebo, benazepril was associated with a 43
percent reduction in the risk of the primary end point in group 2 (P=0.005).
This benefit did not appear to be attributable to blood-pressure control.
Benazepril therapy was associated with a 52 percent reduction in the level
of proteinuria and a reduction of 23 percent in the rate of decline in renal
function. The overall incidence of major adverse events in the benazepril
and placebo subgroups of group 2 was similar. |
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