title: Efficacy and safety of benazepril for advanced chronic renal insufficiency.
abstract: 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.)
authors.affiliation: Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou, China. ffhou@public.guangzhou.gd.cn
authors.forename: Fan Fan
authors.initials: FF
authors.lastname: Hou
authors.forename: Xun
authors.initials: X
authors.lastname: Zhang
authors.forename: Guo Hua
authors.initials: GH
authors.lastname: Zhang
authors.forename: Di
authors.initials: D
authors.lastname: Xie
authors.forename: Ping Yan
authors.initials: PY
authors.lastname: Chen
authors.forename: Wei Ru
authors.initials: WR
authors.lastname: Zhang
authors.forename: Jian Ping
authors.initials: JP
authors.lastname: Jiang
authors.forename: Min
authors.initials: M
authors.lastname: Liang
authors.forename: Guo Bao
authors.initials: GB
authors.lastname: Wang
authors.forename: Zheng Rong
authors.initials: ZR
authors.lastname: Liu
authors.forename: Ren Wen
authors.initials: RW
authors.lastname: Geng
mesh_terms: D000328:Adult; D000368:Aged; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000627:therapeutic use; D001552:Benzazepines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D002681:China; D003404:Creatinine / Q000097:blood; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007676:Kidney Failure, Chronic / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D011507:Proteinuria / Q000188:drug therapy; D051436:Renal Insufficiency, Chronic / Q000188:drug therapy* / Q000401:mortality
chemical_list: D000806:Angiotensin-Converting Enzyme Inhibitors; D000959:Antihypertensive Agents; D001552:Benzazepines; D003404:Creatinine; C044946:benazepril