ArticleCureus2026
Hypothesis-Generating Analysis of Four Immunosuppressive Regimens After Simultaneous Pancreas-Kidney Transplantation Using the United States Food and Drug Administration Adverse Event Reporting System.
Article in Cureus, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background Simultaneous pancreas-kidney (SPK) transplantation is a key treatment option for patients with diabetes and end-stage renal disease, but intensive multidrug immunosuppression increases the risk of adverse events (AEs). Evidence guiding stepwise de-escalation of immunosuppressive regimens in this setting remains limited, as prospective studies are difficult to conduct due to the rarity and complexity of the procedure. Large postmarketing pharmacovigilance databases such as the United States Food and Drug Administration Adverse Event Reporting System (FAERS) provide an opportunity to evaluate the safety of immunosuppressive strategies in real‑world practice. Objectives To characterize exploratory AE reporting patterns across four post-transplant immunosuppressive regimens after SPK transplantation. Methods AE reports for SPK transplant recipients were retrieved from the FAERS database (2004Q1-2025Q2). Immunosuppressive exposure was classified into four regimen groups: tacrolimus, mycophenolate mofetil, prednisone, and basiliximab (TMPB); tacrolimus, mycophenolate mofetil, and prednisone (TMP); tacrolimus and mycophenolate mofetil (TM); and tacrolimus monotherapy (T). Reports involving additional immunosuppressive agents were excluded. Transplant rejection, infections, and other clinically relevant AEs were grouped into predefined categories, and serious AEs (SAEs) were identified according to regulatory criteria. Reporting proportions were calculated for each AE category, and reporting odds ratios (RORs) and adjusted RORs (aRORs) were estimated using the TMPB group as the reference, with adjustment for sex, age, and continent. A Bonferroni‑adjusted two‑sided significance level of 0.017 was applied to account for three primary between‑regimen comparisons. Results A total of 569 SPK recipients met the inclusion criteria (TMPB group,
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