Conversion to tacrolimus extended-release formulation: short-term clinical results

Area of Science:

• Nephrology
• Transplantation Immunology
• Clinical Pharmacy

Background:

• Tacrolimus is a key immunosuppressant in kidney transplantation.
• Twice-daily tacrolimus (BID TAC) requires frequent dosing.
• Extended-release formulations offer potential for improved adherence and convenience.

Purpose of the Study:

• To evaluate the short-term clinical outcomes of converting stable kidney transplant recipients from BID TAC to once-daily tacrolimus (OD TAC) on a milligram-for-milligram basis.
• To assess the safety of this conversion in terms of renal function, metabolic parameters, and rejection incidence.

Main Methods:

• A cohort of 38 stable kidney transplant recipients was switched from BID TAC to OD TAC (milligram for milligram).
• Patients were monitored for clinical and laboratory parameters at 7, 21, and 90 days post-conversion.
• Key assessments included serum creatinine, blood glucose, hemoglobin, proteinuria, and tacrolimus concentrations.

Main Results:

• No significant changes were observed in renal function, blood glucose, hemoglobin, or proteinuria.
• No acute rejection episodes occurred.
• Tacrolimus concentrations decreased significantly post-conversion, particularly in patients receiving lower doses.

Conclusions:

• Milligram-for-milligram conversion from BID TAC to OD TAC is clinically safe in stable kidney transplant recipients.
• Close monitoring of tacrolimus levels is essential, especially for patients on lower doses, to prevent subtherapeutic concentrations.