Efficacy and Safety of Benazepril for Advanced Chronic Renal Insufficiency

作者：Fan Fan Hou, Xun Zhang, Guo Hua Zhang, Di Xie, Ping Yan Chen, Wei Ru Zhang, Jian Jiang, Min Liang, Guo Bao Wang, Zheng Rong Liu, Ren Wen Geng · 发表于：New England Journal of Medicine · 年份：2006 · DOI：10.1056/nejmoa053107 · 被引用次数：713 · 研究领域：Blood Pressure and Hypertension Studies、Chronic Kidney Disease and Diabetes、Diabetes Treatment and Management

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. Bena...