Sirolimus vs mycophenolate mofetil (MMF) in primary combined pancreas and kidney transplantation. Results of a long‐term prospective randomized study

• Published in: American journal of transplantation Vol. 20; no. 3; pp. 779 - 787
• Main Authors: Girman, Peter, Lipár, Květoslav, Kočík, Matěj, Voska, Luděk, Kožnarová, Radomíra, Marada, Tomáš, Lánská, Věra, Saudek, František
• Format: Journal Article
• Language: English
• Published: United States Elsevier Limited 01.03.2020
• Subjects: clinical research/practice; Diabetes; Diabetes mellitus; diabetes: type 1; Graft rejection; Graft Rejection - drug therapy; Graft Rejection - etiology; Graft Rejection - prevention & control; Graft Survival; Humans; immunosuppressant ‐ mechanistic target of rapamycin: sirolimus; Immunosuppressive Agents - therapeutic use; Kidney diseases; Kidney Transplantation; Kidney transplants; Mycophenolate mofetil; Mycophenolic acid; Mycophenolic Acid - therapeutic use; Pancreas; Pancreas Transplantation; pancreas/simultaneous pancreas‐kidney transplantation; Prospective Studies; Rapamycin; Sirolimus - therapeutic use; Surgery; Survival; Tacrolimus; Transplants & implants; diabetes: type 1; immunosuppressant - mechanistic target of rapamycin: sirolimus; pancreas/simultaneous pancreas-kidney transplantation; clinical research/practice
• ISSN: 1600-6135; 1600-6143
• DOI: 10.1111/ajt.15622

The study was intended to compare pancreas graft survival rates in two groups of pancreas and kidney transplant recipients prospectively randomized to treatment either with sirolimus or MMF. From 2002 to 2013, 238 type 1 diabetic recipients with end‐stage kidney disease were randomized 1:1 to sirolimus or MMF treatment. Noncensored pancreas survival at 5 years was 76.4 and 71.6% for sirolimus and MMF groups, respectively (P > .05). Death‐censored pancreas survival was better in the sirolimus group (P = .037). After removal of early graft losses pancreas survival did not differ between groups (MMF 83.1% vs sirolimus 91.6%, P = .11). Nonsignificantly more grafts were lost due to rejection in the MMF group (10 vs 5; P = .19). Cumulative patient 5‐year survival was 96% in the MMF group and 91% in the sirolimus group (P > .05). Five‐year cumulative noncensored kidney graft survival rates did not statistically differ (85.6% in the sirolimus group and 88.8% in MMF group). Recipients treated with MMF had significantly more episodes of gastrointestinal bleeding (7 vs 0, P = .007). More recipients in the sirolimus group required corrective surgery due to incisional hernias (21 vs 12, P = .019). ClinicalTrials No.: NCT 03582878. Combining sirolimus with tacrolimus results in similar pancreas graft survival and a lower rejection rate in comparison to tacrolimus with mycophenolate mofetil in recipients of simultaneous pancreas and kidney transplantation.