title: Long-term outcome of sirolimus rescue in kidney-pancreas transplantation.
abstract: The aim of this study was to evaluate long-term outcome of sirolimus (SRL) rescue in kidney-pancreas transplantation (KPTx). We reviewed 112 KPTx performed at our institution from 12/3/95 to 6/27/02. All patients received antibody (Ab) induction, tacrolimus (TAC), mycophenolate mofetil (MMF), and steroids. Thirty-five patients (31%) had SRL substituted for MMF for the following indications: (1) acute rejection (AR) of kidney or pancreas despite adequate TAC levels; (2) intolerance of full-dose MMF; (3) rising creatinine; and (4) TAC-induced hyperglycemia. Target SRL and TAC levels were 10 ng/mL and 5 ng/mL, respectively. Mean follow-up was 3 +/- 2 years overall and 1.2 +/- 0.5 years after SRL rescue. No patients died. One- and 3-year actuarial kidney and pancreas graft survival was 97%, 97%, and 95%, 90%, respectively. Of 10 patients switched to SRL for AR, 1 kidney failed from Ab-resistant AR, 1 kidney developed borderline AR, and the other 8 remain AR-free. Seven other patients developed AR despite therapeutic SRL levels; of these, 6 (86%) had mean TAC levels of <4.5 in the month preceding AR. Mean creatinine overall and for the rising creatinine group remained stable. All patients switched to SRL for TAC-induced hyperglycemia or MMF intolerance demonstrated biochemical or clinical improvement. Sirolimus-related infection or other serious adverse events (SAE) were uncommon. In conclusion, KPTx recipients can be safely switched to SRL with long-term stabilization of renal function, excellent graft and patient survival, and no increase in SAE. A minimum TAC level of 4.5 ng/mL may be necessary to prevent late AR.
authors.affiliation: Division of Transplant Surgery, Medical University of South Carolina, Charleston, 29425, USA. rogersje@musc.edu
authors.forename: J
authors.initials: J
authors.lastname: Rogers
authors.forename: E E
authors.initials: EE
authors.lastname: Ashcraft
authors.forename: P K
authors.initials: PK
authors.lastname: Baliga
authors.forename: K D
authors.initials: KD
authors.lastname: Chavin
authors.forename: A
authors.initials: A
authors.lastname: Lin
authors.forename: O
authors.initials: O
authors.lastname: Emovon
authors.forename: F
authors.initials: F
authors.lastname: Afzal
authors.forename: G M
authors.initials: GM
authors.lastname: Baillie
authors.forename: D J
authors.initials: DJ
authors.lastname: Taber
authors.forename: S
authors.initials: S
authors.lastname: Alvarez
authors.forename: R C
authors.initials: RC
authors.lastname: Pullatt
authors.forename: P R
authors.initials: PR
authors.lastname: Rajagopalan
mesh_terms: D003404:Creatinine / Q000097:blood; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016030:Kidney Transplantation / Q000276:immunology* / Q000379:methods / Q000502:physiology; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016035:Pancreas Transplantation / Q000276:immunology* / Q000379:methods; D012189:Retrospective Studies; D020123:Sirolimus / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D003404:Creatinine; D009173:Mycophenolic Acid; D020123:Sirolimus