Journal of transplantation · 2026
Sirolimus Versus Mycophenolate Mofetil in Simultaneous Pancreas-Kidney Transplantation: Impact on Urinary Tract Infection Rates.
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Píšová Barbora, Chytilová Šárka, Saudek František, Girman Peter
Аннотация
BACKGROUND: Urinary tract infections (UTIs) are common complications following simultaneous pancreas and kidney transplantation (SPK). The role of specific immunosuppressive agents in modulating UTI incidence and recurrence remains poorly understood.
METHODS: In this retrospective, single-center study, we analyzed 164 SPK recipients randomized to receive either sirolimus or mycophenolate mofetil (MMF) in combination with tacrolimus. The incidence of UTIs, relapses, recurrences, and UTI-related hospitalizations was assessed over a 10-year follow-up. Univariable and multivariable negative binomial regression models were used to evaluate associations with immunosuppressive regimens and clinical outcomes in both intention-to-treat (ITT) and per-protocol analyses.
RESULTS: A total of 572 UTI episodes were recorded during follow-up (0.102 per 100 recipient-transplant days). No significant differences in overall UTI incidence or UTI-related hospitalizations were observed between the sirolimus and MMF groups. However, in the multivariable per-protocol analysis, the sirolimus group experienced significantly fewer UTI-related hospitalizations (IRR 0.46; 95% CI, 0.23-0.94; p = 0.034) and relapses (IRR 0.54; 95% CI, 0.30-0.97; p = 0.039). Significant risk factors for UTIs included female sex, JJ stent placement, and pretransplant urological abnormalities. Recurrent UTIs were associated with lower 10-year kidney graft survival (52% vs. 75%; p = 0.01) but had no impact on pancreas graft or patient survival.
CONCLUSIONS: While overall UTI incidence did not differ between immunosuppressive regimens, sirolimus use was associated with fewer hospitalizations and relapses. These findings indicate a potential clinical benefit of sirolimus in selected high-risk SPK recipients, highlighting the need for further prospective investigation. Trial Registration: ClinicalTrials.gov identifier: NCT00140543.
METHODS: In this retrospective, single-center study, we analyzed 164 SPK recipients randomized to receive either sirolimus or mycophenolate mofetil (MMF) in combination with tacrolimus. The incidence of UTIs, relapses, recurrences, and UTI-related hospitalizations was assessed over a 10-year follow-up. Univariable and multivariable negative binomial regression models were used to evaluate associations with immunosuppressive regimens and clinical outcomes in both intention-to-treat (ITT) and per-protocol analyses.
RESULTS: A total of 572 UTI episodes were recorded during follow-up (0.102 per 100 recipient-transplant days). No significant differences in overall UTI incidence or UTI-related hospitalizations were observed between the sirolimus and MMF groups. However, in the multivariable per-protocol analysis, the sirolimus group experienced significantly fewer UTI-related hospitalizations (IRR 0.46; 95% CI, 0.23-0.94; p = 0.034) and relapses (IRR 0.54; 95% CI, 0.30-0.97; p = 0.039). Significant risk factors for UTIs included female sex, JJ stent placement, and pretransplant urological abnormalities. Recurrent UTIs were associated with lower 10-year kidney graft survival (52% vs. 75%; p = 0.01) but had no impact on pancreas graft or patient survival.
CONCLUSIONS: While overall UTI incidence did not differ between immunosuppressive regimens, sirolimus use was associated with fewer hospitalizations and relapses. These findings indicate a potential clinical benefit of sirolimus in selected high-risk SPK recipients, highlighting the need for further prospective investigation. Trial Registration: ClinicalTrials.gov identifier: NCT00140543.