Torres, ArmandoRodríguez-Adanero, ConcepciónFernández Rivera, ConstantinoMarrero-Miranda, Domingode Bonis-Redondo, EduardoRodríguez-Hernández, Aurelio P.Pérez-Tamajón, LourdesGonzález-Rinne, AnaÁlvarez-Sosa, DiegoÁlvarez-González, AlejandraSánchez-Dorta, NuriaPérez-Carreño, EstefaníaDíaz-Martín, LauraLuis-Lima, SergioRodríguez-Rodríguez, Ana E.Vera-González, Antonia María deRomero-Delgado, CristinaCalvo-Rodríguez, MaríaSeijo Bestilleiro, RocíoRodríguez-Jiménez, ConsueloPrieto-López, Manuel ArturoRivero-González, Antonio ManuelHernández-Marrero, DomingoPorrini, Esteban2025-02-052025-02-052024-12-20Torres A, Rodríguez-Adanero C, Fernández-Rivera C, Marrero-Miranda D, de Bonis-Redondo E, Rodríguez-Hernández AP, Pérez-Tamajón L, González-Rinne A, Álvarez-Sosa D, Álvarez-González A, Sanchez-Dorta N, Pérez-Carreño E, Díaz-Martín L, Luis-Lima S, Rodríguez-Rodríguez AE, Vera González AM, Romero-Delgado C, Calvo-Rodríguez M, Seijo-Bestilleiro R, Rodríguez-Jiménez C, Prieto López MA, Rivero-González AM, Hernández-Marrero D, Porrini E. Efficacy of the once-daily tacrolimus formulation LCPT compared to the immediate-release formulation in preventing early post-transplant diabetes in high-risk kidney transplant patients: a randomized, controlled, open-label pilot study (EUDRACT: 2017-000718-52). J Clin Med. 2024 Dec 20;13(24):7802.2077-0383http://hdl.handle.net/2183/41069[Abstract] Background/Objectives: Post-transplant diabetes mellitus (PTDM) and prediabetes (PreDM) are common after renal transplantation and increase the risk of cardiovascular events and mortality. Compared to immediate-release tacrolimus (IR-Tac), the LCPT formulation, with delayed absorption, offers higher bioavailability and a smoother time-concentration curve, potentially reducing beta-cell stress. Methods: This randomized pilot trial compared de novo immunosuppression with IR-Tac (twice daily) and LCPT (once daily). At-risk recipients (age ≥ 60 years or 18-59 years with metabolic syndrome) were enrolled and followed for 3 months. The primary and secondary outcomes were the incidence of PTDM and PreDM, respectively. Results: 27 patients were randomized to IR-Tac and 25 to LCPT. The incidence of PTDM was comparable between groups [IR Tac: 18.5% (95% CI: 8.2-36.7%) vs. LCPT: 24% (95% CI: 11.5-43.4%); p = 0.7]. Although not statistically significant, the LCPT group exhibited a trend toward a reduction in PreDM incidence [IR-Tac: 40.7% (95% CI: 25-59%) vs. LCPT: 20% (95% CI: 9-39%); p = 0.1]. A sensitivity analysis showed similar results, with no significant differences in cumulative corticosteroid doses or baseline body mass index (BMI) between groups. The LCPT group showed a trend toward higher tacrolimus exposure at the end of the study [trough levels: IR-Tac group 8.3 (6.9-9.2) vs. LCPT group 9.4 (7.4-11.4) ng/mL; p = 0.05)], as well as fewer acute rejection episodes (none vs. three). Delayed graft function was more common in the IR-Tac group (37% vs. 8%; p = 0.01), and the eGFR was lower. Adverse events were comparable between groups. Conclusions: The potential biological activity of LCPT in preventing glucose metabolic alterations in at-risk patients warrants further investigation.engCreative Commons Attribution 4.0 International Licensehttp://creativecommons.org/licenses/by/3.0/es/LCPT tacrolimusEarly-release tacrolimusKidney transplantationPost-transplant diabetesPost-transplant prediabetesTacrolimus pharmacokineticsjournal articleopen access10.3390/jcm13247802