title: Three-year health-related quality-of-life outcomes for sirolimus-treated kidney transplant patients after elimination of cyclosporine.
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.
authors.affiliation: The Queen Elizabeth Hospital, Woodville, Woodville South, SA, Australia.
authors.forename: Graeme
authors.initials: G
authors.lastname: Russ
authors.forename: Neville
authors.initials: N
authors.lastname: Jamieson
authors.forename: Rainer
authors.initials: R
authors.lastname: Oberbauer
authors.forename: Manuel
authors.initials: M
authors.lastname: Arias
authors.forename: Maria G
authors.initials: MG
authors.lastname: Murgia
authors.forename: Gilles
authors.initials: G
authors.lastname: Blancho
authors.forename: Reiko
authors.initials: R
authors.lastname: Sato
authors.forename: Maria
authors.initials: M
authors.lastname: Stoeckl
authors.forename: Dennis A
authors.initials: DA
authors.lastname: Revicki
mesh_terms: D000328:Adult; D016572:Cyclosporine / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000188:drug therapy* / Q000523:psychology; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007676:Kidney Failure, Chronic / Q000601:surgery*; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012189:Retrospective Studies; D020123:Sirolimus / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D016572:Cyclosporine; D020123:Sirolimus