title: Acetylcysteine for the prevention of renal outcomes in patients with diabetes mellitus undergoing coronary and peripheral vascular angiography: a substudy of the acetylcysteine for contrast-induced nephropathy trial.
abstract: BACKGROUND
  Diabetes mellitus represents an independent risk factor for contrast-induced acute kidney injury. We report the results of a prespecified substudy of patients with diabetes mellitus included in the Acetylcysteine for Contrast-Induced Nephropathy Trial (ACT), the largest randomized study evaluating the effects of acetylcysteine for the prevention of contrast-induced acute kidney injury conducted to date.
  
  
  RESULTS
  From the 2308 patients included in the ACT, 1395 had diabetes mellitus and were considered for the present analysis. The study drugs (acetylcysteine 1200 mg or matching placebo) were administered orally twice daily for 2 doses before and 2 doses after the procedure. The allocation was concealed (central Web-based randomization). Participants, healthcare staff, data collectors, and outcome assessors were blinded. All analysis followed the intention-to-treat principle. The incidence of contrast-induced acute kidney injury (primary end point) was 13.8% in the acetylcysteine group and 14.7% in the control group (relative risk 0.93; 95% confidence interval, 0.69-1.26; P=0.64). A combined end point of death or need for dialysis at 30 days was also similar in both the groups (2.2% and 2.1%, respectively; hazard ratio, 1.07; 95% confidence interval, 0.52-2.19; P=0.86).
  
  
  CONCLUSIONS
  In this subanalysis, acetylcysteine did not reduce the risk of contrast-induced acute kidney injury or other clinically relevant outcomes in patients with diabetes mellitus undergoing coronary and peripheral vascular angiography.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT00736866.
authors.affiliation: Research Institute-Hospital do Coração (HCor), São Paulo, Brazil. oberwanger@hcor.com.br
authors.forename: Otavio
authors.initials: O
authors.lastname: Berwanger
authors.forename: Alexandre Biasi
authors.initials: AB
authors.lastname: Cavalcanti
authors.forename: Amanda M G
authors.initials: AM
authors.lastname: Sousa
authors.forename: Anna
authors.initials: A
authors.lastname: Buehler
authors.forename: Helio José
authors.initials: HJ
authors.lastname: Castello-Júnior
authors.forename: Marcelo J C
authors.initials: MJ
authors.lastname: Cantarelli
authors.forename: José Armando
authors.initials: JA
authors.lastname: Mangione
authors.forename: Ricardo R
authors.initials: RR
authors.lastname: Bergo
authors.forename: Luiz Eduardo K
authors.initials: LE
authors.lastname: São Thiago
authors.forename: Paulo M S
authors.initials: PM
authors.lastname: Nunes
authors.forename: Paulo Antônio Marra
authors.initials: PA
authors.lastname: da Motta
authors.forename: Alessandra
authors.initials: A
authors.lastname: Kodama
authors.forename: Elivane
authors.initials: E
authors.lastname: Victor
authors.forename: Vitor Oliveira
authors.initials: VO
authors.lastname: Carvalho
authors.forename: Jose Eduardo
authors.initials: JE
authors.lastname: Sousa
mesh_terms: D000111:Acetylcysteine / Q000008:administration & dosage*; D058186:Acute Kidney Injury / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D000368:Aged; D003287:Contrast Media / Q000009:adverse effects*; D017023:Coronary Angiography / Q000009:adverse effects; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging* / Q000401:mortality; D003925:Diabetic Angiopathies / Q000000981:diagnostic imaging* / Q000401:mortality; D005260:Female; D016166:Free Radical Scavengers / Q000008:administration & dosage; D005919:Glomerular Filtration Rate; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D016491:Peripheral Vascular Diseases / Q000000981:diagnostic imaging* / Q000401:mortality; D010919:Placebos; D012307:Risk Factors; D017211:Treatment Failure
chemical_list: D003287:Contrast Media; D016166:Free Radical Scavengers; D010919:Placebos; D000111:Acetylcysteine