title: Effect of fluvastatin on cardiac outcomes in renal transplant recipients: a multicentre, randomised, placebo-controlled trial.
abstract: BACKGROUND
  Renal transplant recipients are at increased risk of premature cardiovascular disease. Although statins reduce cardiovascular risk in the general population, their efficacy and safety in renal transplant recipients have not been established. We investigated the effects of fluvastatin on cardiac and renal endpoints in this population.
  
  
  METHODS
  We did a multicentre, randomised, double-blind, placebo-controlled trial in 2102 renal transplant recipients with total cholesterol 4.0-9.0 mmol/L. We randomly assigned patients fluvastatin (n=1050) or placebo (n=1052) and follow up was for 5-6 years. The primary endpoint was the occurrence of a major adverse cardiac event, defined as cardiac death, non-fatal myocardial infarction (MI), or coronary intervention procedure. Secondary endpoints were individual cardiac events, combined cardiac death or non-fatal MI, cerebrovascular events, non-cardiovascular death, all-cause mortality, and graft loss or doubling of serum creatinine. Analysis was by intention to treat.
  
  
  RESULTS
  After a mean follow-up of 5.1 years, fluvastatin lowered LDL cholesterol concentrations by 32%. Risk reduction with fluvastatin for the primary endpoint (risk ratio 0.83 [95% CI 0.64-1.06], p=0.139) was not significant, although there were fewer cardiac deaths or non-fatal MI (70 vs 104, 0.65 [0.48-0.88] p=0.005) in the fluvastatin group than in the placebo group. Coronary intervention procedures and other secondary endpoints did not differ significantly between groups.
  
  
  CONCLUSIONS
  Although cardiac deaths and non-fatal MI seemed to be reduced, fluvastatin did not generally reduce rates of coronary intervention procedures or mortality. Overall effects of fluvastatin were similar to those of statins in other populations.
authors.affiliation: hallvard.holdaas@rikshospitalet.no
authors.forename: Hallvard
authors.initials: H
authors.lastname: Holdaas
authors.forename: Bengt
authors.initials: B
authors.lastname: Fellström
authors.forename: Alan G
authors.initials: AG
authors.lastname: Jardine
authors.forename: Ingar
authors.initials: I
authors.lastname: Holme
authors.forename: Gudrun
authors.initials: G
authors.lastname: Nyberg
authors.forename: Per
authors.initials: P
authors.lastname: Fauchald
authors.forename: Carola
authors.initials: C
authors.lastname: Grönhagen-Riska
authors.forename: Søren
authors.initials: S
authors.lastname: Madsen
authors.forename: Hans-Hellmut
authors.initials: HH
authors.lastname: Neumayer
authors.forename: Edward
authors.initials: E
authors.lastname: Cole
authors.forename: Bart
authors.initials: B
authors.lastname: Maes
authors.forename: Patrice
authors.initials: P
authors.lastname: Ambühl
authors.forename: Anders G
authors.initials: AG
authors.lastname: Olsson
authors.forename: Anders
authors.initials: A
authors.lastname: Hartmann
authors.forename: Dag O
authors.initials: DO
authors.lastname: Solbu
authors.forename: Terje R
authors.initials: TR
authors.lastname: Pedersen
mesh_terms: D000328:Adult; D000368:Aged; D000924:Anticholesteremic Agents / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D008078:Cholesterol, LDL / Q000097:blood / Q000187:drug effects; D004311:Double-Blind Method; D004347:Drug Interactions; D005229:Fatty Acids, Monounsaturated / Q000627:therapeutic use*; D005260:Female; D000077340:Fluvastatin; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D007211:Indoles / Q000627:therapeutic use*; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D010919:Placebos; D012307:Risk Factors
chemical_list: D000924:Anticholesteremic Agents; D008078:Cholesterol, LDL; D005229:Fatty Acids, Monounsaturated; D007166:Immunosuppressive Agents; D007211:Indoles; D010919:Placebos; D000077340:Fluvastatin