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N Engl J Med. 2006 Jan 12;354(2):131-40.

Efficacy and safety of benazepril for advanced chronic renal insufficiency.

Hou FF, Zhang X, Zhang GH, Xie D, Chen PY, Zhang WR, Jiang JP, Liang M, Wang
GB, Liu ZR, Geng RW.

Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou,
China. ffhou@public.guangzhou.gd.cn

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: Benazepril conferred substantial renal benefits in
patients without diabetes who had advanced renal insufficiency.
(ClinicalTrials.gov number, NCT00270426.) Copyright 2006
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