title: A matched cohort pharmacoepidemiological analysis of steroid free immunosuppression in renal transplantation.
abstract: BACKGROUND
  This longitudinal, sequential, matched closed-cohort design pharmacoepidemiological analysis examined the influence of maintenance steroid therapy in 380 first graft recipients after renal transplantation under conditions of normal clinical practice.
  
  
  METHODS
  Nonexposed (steroid avoidance, n=190) and exposed (steroid treated, n=190) cohorts were matched 1:1 for key demographic factors, including donor source (living or deceased), diabetic status, panel reactive antibody level, recipient age (by decade), and sex.
  
  
  RESULTS
  Cohorts were comparable for all variables except median human leukocyte antigen mismatch (4 vs. 3, P=0.03), use of tacrolimus (90.0% vs. 59.5%, P<or=0.0001), and of basiliximab (94.7% vs. 57.4%, P<or=0.0001), which were higher in the nonexposed cohort. Estimated glomerular filtration rate (mL/min/1.73 m) was comparable at 1 year (median: 58.1 vs. 58.3, P=0.92) and 2 years (median: 55.5 vs. 58.0, P=0.97) in nonexposed and in exposed cohorts (P=0.97). There was no difference in Kaplan-Meier estimates of biopsy-proven acute rejection (14.8% vs. 17.0%; hazard ratio: 0.88, P=0.60) or of 2-year death censored graft failure (4.7% vs. 3.2%; P=0.44) between nonexposed or exposed cohorts. Median total cholesterol (4.6 vs. 5.0 mmol/L, P=0.0002), low-density lipoprotein (2.6 vs. 2.8 mmol/L, P=0.005), high-density lipoprotein levels (1.1 vs. 1.3, P=0.0001), and median weight change from baseline (-1.7 vs. +1.0 kg, P=0.001) were significantly lower in the nonexposed cohort. Forty-five patients (29%) in the nonexposed cohort commenced steroid therapy, principally for graft dysfunction or acute rejection.
  
  
  CONCLUSIONS
  In summary, steroid avoidance did not negatively impact 2-year graft function, biopsy-proven acute rejection rate, or short-term graft survival and offers clinical benefits, which weigh in the decision regarding maintenance therapy.
authors.affiliation: Division of Nephrology, Vancouver General Hospital, Diamond Health Care Centre, Vancouver BC, Canada.
authors.forename: Katherine A
authors.initials: KA
authors.lastname: Barraclough
authors.forename: David N
authors.initials: DN
authors.lastname: Landsberg
authors.forename: R Jean
authors.initials: RJ
authors.lastname: Shapiro
authors.forename: John S
authors.initials: JS
authors.lastname: Gill
authors.forename: Guiyun
authors.initials: G
authors.lastname: Li
authors.forename: Robert F
authors.initials: RF
authors.lastname: Balshaw
authors.forename: Worawon
authors.initials: W
authors.lastname: Chailimpamontree
authors.forename: Paul A
authors.initials: PA
authors.lastname: Keown
mesh_terms: D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000328:Adult; D015331:Cohort Studies; D005260:Female; D006084:Graft Rejection / Q000453:epidemiology; D006680:HLA Antigens / Q000032:analysis; D006650:Histocompatibility Testing; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D015994:Incidence; D007674:Kidney Diseases / Q000145:classification / Q000601:surgery; D016030:Kidney Transplantation / Q000276:immunology* / Q000401:mortality; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis
chemical_list: D000305:Adrenal Cortex Hormones; D006680:HLA Antigens; D007166:Immunosuppressive Agents