http://content.nejm.org/cgi/content/full/354/2/131 Efficacy and Safety of Benazepril for Advanced Chronic Renal Insufficiency
Background Angiotensin-converting–enzyme inhibitors provide renal protectio
n in patients with mild-to-moderate renal insufficiency (serum creatinine le
vel, 3.0 mg per deciliter or less). We assessed the efficacy and safety of b
enazepril 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, wh
ereas 224 patients with serum creatinine levels of 3.1 to 5.0 mg per decilit
er (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 prim
ary outcome was the composite of a doubling of the serum creatinine level, e
nd-stage renal disease, or death. Secondary end points included changes in t
he 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 p
ercent) and 65 of 107 patients given placebo in group 2 (60 percent). As com
pared 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 no
t appear to be attributable to blood-pressure control. Benazepril therapy wa
s associated with a 52 percent reduction in the level of proteinuria and a r
eduction of 23 percent in the rate of decline in renal function. The overall
incidence of major adverse events in the benazepril and placebo subgroups o
f group 2 was similar。
Conclusions Benazepril conferred substantial renal benefits in patients without diabetes who had advanced renal insufficiency. (ClinicalTrials.gov number, NCT00270426 ）
