title: Risk factors for reaching renal endpoints in the assessment of Lescol in renal transplantation (ALERT) trial.
abstract: BACKGROUND
  The aim of the study was to identity risk factors for long-term renal transplant function and development of chronic allograft nephropathy (CAN) in renal transplant recipients included in the Assessment of Lescol in Renal Transplantation (ALERT) trial.
  
  
  METHODS
  The ALERT trial was a randomized, double-blind, placebo-controlled study of the effect of fluvastatin, 40 and 80 mg/day, in renal transplant recipients who were randomized to receive fluvastatin (Lescol) (n = 1,050) or placebo (n = 1,052) over 5 to 6 years of follow-up. Renal endpoints including graft loss or doubling of serum creatinine or death were analyzed by univariate and multivariate regression analysis in the placebo group.
  
  
  RESULTS
  There were 137 graft losses (13.5%) in the placebo group, mainly caused by CAN (82%). Univariate risk factors for graft loss or doubling of serum creatinine were as follows: serum creatinine, proteinuria, hypertension, pulse pressure, time since transplantation, donor age, human leukocyte antigen-DR mismatches, treatment for rejection, low high-density lipoprotein cholesterol, and smoking. Multivariate analysis revealed independent risk factors for graft loss as follows: serum creatinine (relative risk [RR], 3.12 per 100-microM increase), proteinuria (RR, 1.64 per 1-g/24 hr increase), and pulse pressure (RR, 1.12 per 10 mm Hg), whereas age was a protective factor. With patient death in the composite endpoint, diabetes mellitus, smoking, age, and number of transplantations were also risk factors.
  
  
  CONCLUSIONS
  Independent risk factors for graft loss or doubling of serum creatinine or patient death are mainly related to renal transplant function, proteinuria, and blood pressure, which emphasizes the importance of renoprotective treatment regimens in this population.
authors.affiliation: Department of Medical Science, Renal Science, Renal Unit, University Hospital, Uppsala, Sweden. bengt.fellstrom@medsci.uu.se
authors.forename: Bengt
authors.initials: B
authors.lastname: Fellström
authors.forename: Hallvard
authors.initials: H
authors.lastname: Holdaas
authors.forename: Alan G
authors.initials: AG
authors.lastname: Jardine
authors.forename: Gudrun
authors.initials: G
authors.lastname: Nyberg
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: Beatrix
authors.initials: B
authors.lastname: Staffler
authors.forename: Terje R
authors.initials: TR
authors.lastname: Pedersen
mesh_terms: D000328:Adult; D000704:Analysis of Variance; D003404:Creatinine / Q000097:blood; D004311:Double-Blind Method; D005229:Fatty Acids, Monounsaturated / Q000627:therapeutic use*; D005260:Female; D000077340:Fluvastatin; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007211:Indoles / Q000627:therapeutic use*; D016030:Kidney Transplantation / Q000276:immunology* / Q000473:pathology / Q000502:physiology; D008297:Male; D008875:Middle Aged; D010919:Placebos; D012307:Risk Factors; D014184:Transplantation, Homologous / Q000473:pathology
chemical_list: D005229:Fatty Acids, Monounsaturated; D007166:Immunosuppressive Agents; D007211:Indoles; D010919:Placebos; D000077340:Fluvastatin; D003404:Creatinine