title: Health-related quality-of-life outcomes of sirolimus-treated kidney transplant patients after elimination of cyclosporine A: results of a 2-year randomized clinical trial.
abstract: BACKGROUND
  This study compared 2-year health-related quality-of-life (HRQL) outcomes of sirolimus (SRL)-treated kidney transplant patients after elimination of cyclosporine A (CsA) to patients continuing on a combined CsA and SRL regimen.
  
  
  METHODS
  A randomized, open-label, clinical trial was performed in Europe, Australia, and Canada. Four hundred thirty kidney transplant patients were randomly assigned to sirolimus plus steroids (ST) (n=215) or SRL and CsA+ST (n=215) therapy after 3 months of combined SRL+CsA+ST treatment. HRQL was measured using the Kidney Transplant Questionnaire (KTQ) and the SF-36 Health Survey at month 3 (time of randomization) and months 12 and 24 after transplantation. Repeated-measures analysis of covariance was used to evaluate treatment differences in HRQL scores over the 2-year period.
  
  
  RESULTS
  HRQL scores were available for 361 (86%) eligible study patients. Statistically significant treatment-by-assessment time interactions, favoring SRL+ST, were found on KTQ Fatigue (P=0.0158) and Appearance scores (P=0.0007). No treatment differences were observed in KTQ Physical Symptom, Uncertainty-Fear, and Emotion scores. Statistically significant treatment-by-assessment time interactions were observed for SF-36 Vitality scores (P=0.0203) but not other SF-36 scores (P>0.05). For Vitality scores, the SRL+ST group remained stable (mean, 0.4-point change) from month 3 to month 24 compared with decreases in the SRL+CsA+ST group (mean, -6.5-point change).
  
  
  CONCLUSIONS
  SRL-based therapy with early elimination of CsA results in fewer appearance-related problems, less fatigue, and better vitality compared with continuous treatment with SRL, CsA, and ST.
authors.affiliation: Allgemeines Krankenhaus, Wien, Austria.
authors.forename: Rainer
authors.initials: R
authors.lastname: Oberbauer
authors.forename: Brian
authors.initials: B
authors.lastname: Hutchison
authors.forename: Josette
authors.initials: J
authors.lastname: Eris
authors.forename: Manuel
authors.initials: M
authors.lastname: Arias
authors.forename: Kerstin
authors.initials: K
authors.lastname: Claesson
authors.forename: Alfredo
authors.initials: A
authors.lastname: Mota
authors.forename: Henri
authors.initials: H
authors.lastname: Kreis
authors.forename: Leah
authors.initials: L
authors.lastname: Kleinman
authors.forename: F
authors.initials: F
authors.lastname: Wang
authors.forename: J
authors.initials: J
authors.lastname: Chen
authors.forename: Dennis A
authors.initials: DA
authors.lastname: Revicki
mesh_terms: D000328:Adult; D000704:Analysis of Variance; D016572:Cyclosporine / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004644:Emotions / Q000187:drug effects; D005221:Fatigue / Q000503:physiopathology; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D020123:Sirolimus / Q000008:administration & dosage*; D013256:Steroids / Q000008:administration & dosage; D011795:Surveys and Questionnaires
chemical_list: D007166:Immunosuppressive Agents; D013256:Steroids; D016572:Cyclosporine; D020123:Sirolimus