Effectiveness and safety of the conversion to MeltDose(®) extended-release tacrolimus from other formulations of tacrolimus in stable kidney transplant patients: A retrospective study.
Por:
Sánchez Fructuoso A, Ruiz JC, Franco A, Diekmann F, Redondo D, Calviño J, Serra N, Aladrén MJ, Cigarrán S, Manonelles A, Ramos A, Gómez G, González Posada JM, Andrés A, Beneyto I, Muñiz AL, Perelló M and Lauzurica R
Publicada:
1 ene 2020
Ahead of Print:
31 dic 2019
Resumen:
Tacrolimus is the cornerstone of immunosuppressive therapy after kidney transplantation. Its narrow therapeutic window mandates serum level strict monitoring and dose adjustments to ensure the optimal risk-benefit balance. This observational retrospective study analyzed the effectiveness and safety of conversion from twice-daily immediate-release tacrolimus (IR-Tac) or once-daily prolonged-release tacrolimus (PR-Tac) to the recent formulation once-daily MeltDose(®) extended-release tacrolimus (LCP-Tac) in 365 stable kidney transplant recipients. We compared kidney function three months before and three months after the conversion. Three months after conversion, the total daily dose was reduced ~35% (P < .0001), and improved bioavailability and stable serum LCP-Tac concentrations were observed. There was no increase in the number of patients requiring tacrolimus dose adjustments after conversion. Renal function was unaltered, and no cases of BPAR were reported. Reports of tremors, as collected in the clinical histories for each patient, decreased from pre-conversion (20.8%) to post-conversion (11.8%, P < .0001). LCP-Tac generated a cost reduction of 63% compared with PR-Tac. In conclusion, the conversion strategy to LCP-Tac from other tacrolimus formulations in stable kidney transplant patients showed safety and effectiveness in a real-world setting, confirming the data from RCTs. The specific pharmacokinetic properties of LCP-Tac could be potentially advantageous in patients with tacrolimus-related adverse events.
Filiaciones:
Sánchez Fructuoso A:
Nephrology, University Hospital Clínico San Carlos, Madrid, Spain
Ruiz JC:
Nephrology, University Hospital Marqués de Valdecilla, Santander, Spain
Franco A:
Nephrology, University Hospital General, Alicante, Spain
Diekmann F:
Nephrology, University Hospital Clinic, Barcelona, Spain
Redondo D:
Nephrology, University Hospital del Mar, Barcelona, Spain
Calviño J:
Nephrology, Hospital Lucus Augusti, Lugo, Spain
Serra N:
Nephrology, Fundación Puigvert, Barcelona, Spain
Aladrén MJ:
Nephrology, Hospital Miguel Servet, Zaragoza, Spain
Cigarrán S:
Nephrology, Hospital da Costa, Burela, Lugo, Spain
Manonelles A:
Nephrology, University Hospital Bellvitge, Hospitalet de Llobregat, Spain
Ramos A:
Nephrology, Fundación Jiménez Díaz, Madrid, Spain
Gómez G:
Nephrology, University Hospital son Espases, Palma de Mallorca, Spain
González Posada JM:
Nephrology, University Hospital Nuestra Señora de la Candelaria, Santa Cruz de Tenerife, Spain
Andrés A:
Nephrology, University Hospital Doce de Octubre, Madrid, Spain
Beneyto I:
Nephrology, University Hospital La Fe, Valencia, Spain
Muñiz AL:
Nephrology, University Hospital A Coruña, La Coruña, Spain
Perelló M:
Nephrology, University Hospital Vall de Hebrón, Barcelona, Spain
:
Nephrology, University Hospital Germans Trias y Pujol, Badalona, Spain
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