title: Prevention of radiocontrast medium-induced nephropathy using short-term high-dose simvastatin in patients with renal insufficiency undergoing coronary angiography (PROMISS) trial--a randomized controlled study.
abstract: BACKGROUND
  Contrast media cause oxidative stress, which has been suggested as one possible mechanism responsible for contrast-induced nephropathy. Statins appear to have pleiotropic effects, including antioxidant properties. We investigated to determine whether simvastatin pretreatment reduces the risk of contrast-induced nephropathy in a high-risk population of patients with renal insufficiency undergoing coronary angiography.
  
  
  METHODS
  We conducted a prospective, randomized, double-blind, placebo-controlled, 2-center trial, involving 247 consecutive patients with chronic renal insufficiency (calculated creatinine clearance < or = 60 mL/min and/or serum creatinine > or = 1.1 mg/dL) undergoing coronary angiography. Patients were randomized to simvastatin (n = 124; 160 mg total, 40 mg orally every 12 hours starting the evening before and ending the morning after the procedure) or placebo (n = 123). All patients received pre - and postprocedure hydration. The iso-osmolar contrast agent iodixanol was used for coronary angiography in all patients.
  
  
  RESULTS
  There was no difference between simvastatin and placebo in mean peak increase in serum creatinine measured within 48 hours after coronary angiography, the primary study end point (0.002 +/- 0.164 vs 0.017 +/- 0.230 mg/mL respectively, P = .559). The incidence of contrast-induced nephropathy, a secondary end point defined as increase of either > or = 25% or > or = 0.5 mg/dL in serum creatinine, was 2.5% in simvastatin-treated patients (3/118) and 3.4% in placebo-treated patients (4/118), a nonsignificant difference (P = 1.00). There were also no differences between the 2 groups in length of hospital stay or 1- and 6-month clinical outcomes.
  
  
  CONCLUSIONS
  Simvastatin pretreatment for short-term at high dose do not prevent renal function deterioration after administration of contrast medium in patients with baseline renal insufficiency undergoing coronary angiography.
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Seoul National University College of Medicine/Cardiovascular Center, Seoul National University Hospital, Seoul, South Korea.
authors.forename: Sang-Ho
authors.initials: SH
authors.lastname: Jo
authors.forename: Bon-Kwon
authors.initials: BK
authors.lastname: Koo
authors.forename: Jin-Shik
authors.initials: JS
authors.lastname: Park
authors.forename: Hyun-Jae
authors.initials: HJ
authors.lastname: Kang
authors.forename: Young-Seok
authors.initials: YS
authors.lastname: Cho
authors.forename: Yong-Jin
authors.initials: YJ
authors.lastname: Kim
authors.forename: Tae-Jin
authors.initials: TJ
authors.lastname: Youn
authors.forename: Woo-Young
authors.initials: WY
authors.lastname: Chung
authors.forename: In-Ho
authors.initials: IH
authors.lastname: Chae
authors.forename: Dong-Ju
authors.initials: DJ
authors.lastname: Choi
authors.forename: Dae-Won
authors.initials: DW
authors.lastname: Sohn
authors.forename: Byung-Hee
authors.initials: BH
authors.lastname: Oh
authors.forename: Young-Bae
authors.initials: YB
authors.lastname: Park
authors.forename: Yun-Shik
authors.initials: YS
authors.lastname: Choi
authors.forename: Hyo-Soo
authors.initials: HS
authors.lastname: Kim
mesh_terms: D000284:Administration, Oral; D000368:Aged; D003287:Contrast Media / Q000009:adverse effects*; D017023:Coronary Angiography / Q000009:adverse effects*; D003327:Coronary Disease / Q000150:complications / Q000000981:diagnostic imaging*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage*; D015994:Incidence; D007723:Korea / Q000453:epidemiology; D008297:Male; D011446:Prospective Studies; D051437:Renal Insufficiency / Q000139:chemically induced / Q000150:complications* / Q000453:epidemiology / Q000517:prevention & control*; D012307:Risk Factors; D019821:Simvastatin / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome; D014283:Triiodobenzoic Acids / Q000009:adverse effects
chemical_list: D003287:Contrast Media; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D014283:Triiodobenzoic Acids; D019821:Simvastatin; C044834:iodixanol