title: Advantage of rapamycin over mycophenolate mofetil when used with tacrolimus for simultaneous pancreas kidney transplants: randomized, single-center trial at 10 years.
abstract: Simultaneous pancreas kidney transplantation (SPKT) is the treatment of choice for patients with type 1 diabetes and end-stage renal disease. Rapamycin and mycophenolate mofetil (MMF) have been used for maintenance immunosuppression with tacrolimus in SPKT; however, long-term outcomes are lacking. From September 2000 through December 2009, 170 SPKT recipients were enrolled in a randomized, prospective trial receiving Rapamycin (n = 84) or MMF (n = 86). All patients received dual induction therapy with thymoglobulin and daclizumab, and low-dose maintenance tacrolimus and corticosteroids. Compared to MMF, rates of freedom from first biopsy-proven acute kidney or pancreas rejection were superior for Rapamycin at year 1 (kidney: 100% vs. 88%; P = 0.001; pancreas: 99% vs. 92%; P = 0.04) and at year 10 (kidney: 88% vs. 71%, P = 0.01; pancreas: 99% vs. 89%, P = 0.01). The higher rates of rejection were associated with withholding MMF (vs. Rapamycin, p = 0.009), generally for gastrointestinal or bone marrow toxicity. There was no significant difference in creatinine, proteinuria, c-peptide, viral infections, lymphoproliferative disorders or posttransplant diabetes. HbA1C and lipid levels were normal in both groups, although higher in the Rapamycin arm. There were no significant differences in patient or allograft survival. In this 10-year SPKT study, Rapamycin in combination with tacrolimus was better tolerated and more effective than MMF. Overall, the patient and allograft survival were equivalent.
authors.affiliation: Department of Surgery, Lillian Jean Kaplan Renal Transplant Center of the Division of Kidney and Pancreas Transplantation, University of Miami, Leonard M. Miller School of Medicine, Miami, FL, USA.
authors.forename: G
authors.initials: G
authors.lastname: Ciancio
authors.forename: J
authors.initials: J
authors.lastname: Sageshima
authors.forename: L
authors.initials: L
authors.lastname: Chen
authors.forename: J J
authors.initials: JJ
authors.lastname: Gaynor
authors.forename: L
authors.initials: L
authors.lastname: Hanson
authors.forename: L
authors.initials: L
authors.lastname: Tueros
authors.forename: E
authors.initials: E
authors.lastname: Montenora-Velarde
authors.forename: C
authors.initials: C
authors.lastname: Gomez
authors.forename: W
authors.initials: W
authors.lastname: Kupin
authors.forename: G
authors.initials: G
authors.lastname: Guerra
authors.forename: A
authors.initials: A
authors.lastname: Mattiazzi
authors.forename: A
authors.initials: A
authors.lastname: Fornoni
authors.forename: A
authors.initials: A
authors.lastname: Pugliese
authors.forename: D
authors.initials: D
authors.lastname: Roth
authors.forename: M
authors.initials: M
authors.lastname: Wolf
authors.forename: G W
authors.initials: GW
authors.lastname: Burke
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D005260:Female; D006084:Graft Rejection / Q000188:drug therapy*; D006085:Graft Survival / Q000187:drug effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007223:Infant; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016035:Pancreas Transplantation; D011379:Prognosis; D011446:Prospective Studies; D020123:Sirolimus / Q000627:therapeutic use*; D016559:Tacrolimus / Q000627:therapeutic use*; D013997:Time Factors; D014184:Transplantation, Homologous; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid; D020123:Sirolimus; D016559:Tacrolimus