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Type: Journal article
Title: Three-year health-related quality-of-life outcomes for sirolimus-treated kidney transplant patients after elimination of cyclosporine
Author: Russ, G.
Jamieson, N.
Oberbauer, R.
Arias, M.
Murgia, C.
Blancho, G.
Sato, R.
Stoeckl, M.
Revicki, D.
Citation: Transplant International, 2007; 20(10):875-883
Publisher: Springer-Verlag
Issue Date: 2007
ISSN: 0934-0874
Statement of
Graeme Russ, Neville Jamieson, Rainer Oberbauer, Manuel Arias, Maria G. Murgia, Gilles Blancho, Reiko Sato, Maria Stoeckl, Dennis A. Revicki
Abstract: This study compared 3-year health-related quality-of-life (HRQL) outcomes of sirolimus (SRL)-treated kidney transplant patients after elimination of cyclosporine (CsA) with patients continuing on a combined CsA and SRL regimen. A randomized, multi-country, open-label, clinical trial was performed. 430 kidney transplant patients were randomly assigned to SRL+corticosteroids (ST) (n = 215) or SRL+CsA+ST (n = 215) therapy after an initial 3-month period 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, 24, and 36 post-transplantation. Mixed-model ancova was used to evaluate treatment differences in HRQL outcomes. HRQL scores were available for 361 (86.4%) eligible study patients. Significant treatment-by-assessment time interactions, favoring SRL+ST, were found on KTQ fatigue (P = 0.0005), emotions (P = 0.028), and appearance scores (P = 0.006). Statistically significant treatment-by-assessment time interactions were observed for SF-36 vitality (P = 0.0001), general health (P = 0.011), social function (P = 0.020), and role-physical scores (P = 0.049). Vitality scores improved in the SRL+ST group (mean 3.5-point change) over 36 months, compared with decreases in the SRL+CsA+ST group (mean –3.2-point change). SRL-based therapy with early CsA-elimination results in fewer appearance-related problems, less fatigue, greater vitality, and improved general health status and social functioning compared with continuous SRL+CsA+ST treatment.
Keywords: Humans; Kidney Failure, Chronic; Sirolimus; Cyclosporine; Immunosuppressive Agents; Treatment Outcome; Kidney Transplantation; Retrospective Studies; Follow-Up Studies; Graft Rejection; Time Factors; Quality of Life; Adult; Middle Aged; Female; Male; Surveys and Questionnaires
Description: The definitive version can be found at
RMID: 0020076354
DOI: 10.1111/j.1432-2277.2007.00547.x
Appears in Collections:Medicine publications

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