A matched cohort pharmacoepidemiological analysis of steroid free immunosuppression in renal transplantation

Transplantation. 2009 Mar 15;87(5):672-80. doi: 10.1097/TP.0b013e318195aa54.


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.

Conclusion: 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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adrenal Cortex Hormones / therapeutic use
  • Adult
  • Cohort Studies
  • Female
  • Graft Rejection / epidemiology
  • HLA Antigens / analysis
  • Histocompatibility Testing
  • Humans
  • Immunosuppressive Agents / therapeutic use*
  • Incidence
  • Kidney Diseases / classification
  • Kidney Diseases / surgery
  • Kidney Transplantation / immunology*
  • Kidney Transplantation / mortality
  • Longitudinal Studies
  • Male
  • Middle Aged
  • Survival Analysis


  • Adrenal Cortex Hormones
  • HLA Antigens
  • Immunosuppressive Agents