G Valente1, L Rinaldi, M Sgambato, G Piai. 1. UOSD Fisiopatologia Epatica con Servizio di Assistenza ai Trapiantati e Trapiantandi Epatici, AORN Sant'Anna e San Sebastiano, Caserta, Italy. giovannavalente1977@libero.it
Abstract
BACKGROUND: The prolonged-release once-daily (QD) tacrolimus is a formulation developed to improve adherence to immunosuppressant (IS) regimen, reducing the frequency of dosing, and to increase safety, avoiding toxic peak concentrations. We evaluated efficiency and quality of conversion from twice-daily (BID) to QD tacrolimus formulation in stable liver transplant (LT) recipients in the real-setting of a gastrohepatology team peripheral to LT centers. PATIENTS AND METHODS: Thirty-four LT recipients (median age 60 years, range 33-69) were switched from BID tacrolimus to QD tacrolimus (1:1 dose) at a median of 38 months (range 8-211) after transplantation. Tacrolimus levels and laboratory analyses were recorded before and postconversion. Adherence to IS treatment was measured by a modified "Basel Assessment of Adherence Scale to Immunosuppressives." RESULTS: Median postconversion follow-up was 21 months (range 6-35, at least 12 months in 30 patients). Mean total tacrolimus daily dose and mean tacrolimus trough level were not significantly different before and after the switch (3.1 ± 2.3 preconversion versus 3.1 ± 2.5 and 3.0 ± 2.5 mg at 6 and 12 months postconversion, respectively; and 5.3 ± 1.8 preconversion versus 4.6 ± 1.4 and 4.5 ± 1.8 ng/mL at 6 and 12 months postconversion, respectively). All patients maintained stable liver and metabolic parameters. Renal function by glomerular filtration rate increased (67 ± 17 preconversion versus 73 ± 19 and 73 ± 20 mL/min at 6 and 12 months postconversion, respectively; P = .003). No acute rejection episode or major severe adverse events occurred postconversion. Patient-reported outcome showed a reduction of missed IS doses. CONCLUSION: We observed that in a real-world setting far from LT centers, the switch from BID tacrolimus to QD tacrolimus in stable LT recipients is efficient (safe and effective) to improve quality of medical care, with possibly better IS adherence and improvement of renal function.
BACKGROUND: The prolonged-release once-daily (QD) tacrolimus is a formulation developed to improve adherence to immunosuppressant (IS) regimen, reducing the frequency of dosing, and to increase safety, avoiding toxic peak concentrations. We evaluated efficiency and quality of conversion from twice-daily (BID) to QD tacrolimus formulation in stable liver transplant (LT) recipients in the real-setting of a gastrohepatology team peripheral to LT centers. PATIENTS AND METHODS: Thirty-four LT recipients (median age 60 years, range 33-69) were switched from BIDtacrolimus to QD tacrolimus (1:1 dose) at a median of 38 months (range 8-211) after transplantation. Tacrolimus levels and laboratory analyses were recorded before and postconversion. Adherence to IS treatment was measured by a modified "Basel Assessment of Adherence Scale to Immunosuppressives." RESULTS: Median postconversion follow-up was 21 months (range 6-35, at least 12 months in 30 patients). Mean total tacrolimus daily dose and mean tacrolimus trough level were not significantly different before and after the switch (3.1 ± 2.3 preconversion versus 3.1 ± 2.5 and 3.0 ± 2.5 mg at 6 and 12 months postconversion, respectively; and 5.3 ± 1.8 preconversion versus 4.6 ± 1.4 and 4.5 ± 1.8 ng/mL at 6 and 12 months postconversion, respectively). All patients maintained stable liver and metabolic parameters. Renal function by glomerular filtration rate increased (67 ± 17 preconversion versus 73 ± 19 and 73 ± 20 mL/min at 6 and 12 months postconversion, respectively; P = .003). No acute rejection episode or major severe adverse events occurred postconversion. Patient-reported outcome showed a reduction of missed IS doses. CONCLUSION: We observed that in a real-world setting far from LT centers, the switch from BIDtacrolimus to QD tacrolimus in stable LT recipients is efficient (safe and effective) to improve quality of medical care, with possibly better IS adherence and improvement of renal function.