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.
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.
Oberbauer
Rainer
R
Allgemeines Krankenhaus, Wien, Austria.
Hutchison
Brian
B
Eris
Josette
J
Arias
Manuel
M
Claesson
Kerstin
K
Mota
Alfredo
A
Kreis
Henri
H
Kleinman
Leah
L
Wang
F
F
Chen
J
J
Revicki
Dennis A
DA
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
D007166:Immunosuppressive Agents; D013256:Steroids; D016572:Cyclosporine; D020123:Sirolimus