Abstract
Background: Tacrolimus (TAC) as a well demonstrated effectiveness in the prevention of acute rejection after renal transplantation. The TAC extended-released formulation(TAC XL) given once daily improves adherence while keeping the same safety and efficacy profile. The aim of this study is to present our experience with TAC XL used in stable renal transplant patients from two centres in Argentina Methods: Retrospective analysis of renal transplant patients with 3 months of stable renal function and no evidence of acute rejection, converted to TAC XL to improve adherence and a follow up of at least 6 months. 77 patients were included from two centres converted between 06/2008 and 5/2013. Data recorded at baseline and at 6,12 and 24 months after conversion included creatinine, urine Pr/Cr, MDRD, CKD-EPI, dose and trough TAC levels and adverse events We identified 4 groups depending on the TAC dose ratio at conversion, Group 1: same dose, Group 2: reduced dose, Group 3: increased dose, and Group 4: conversion from other regimes different from TAC (CsA or mTORi). Values are expressed as mean ± DS. T test for compare means and Bonforroni test for multiple comparisons between groups. Results: Mean time to conversion was 45,3±38,8 months (3 - 174). Renal function and proteinuria remain stable from baseline to 12, and 24 months: Creatinine (mg/dl) 1,57±0,9; 1,42±0,5 and 1,40±0,5 respectively, MDRD 56,2±20; 57±18,6; 58±19,6 respectively and urine Pr/Cr 0,38±0,72; 0,23±0,38; 0,25±0,47 respectively (P=NS). TAC trough levels and dose remained stable and within the therapeutic rage across the different conversion groups at 6, 12 and 24 months: TAC XL trough level (ng/dl) 7,1±3, 6; 6,5±2,3; and 6,8±2 respectively; and daily dose 4,3±3; 4,1±3; and 3,9±2,5 respectively (p=NS). There were no differences between groups concerning efficacy and safety variables and dose/trough level analysis. Only Group 4 requires higher doses to reach the therapeutic range without statistical significance. 5 (6.5 %) patients experienced rejections (3 cellular, 2 humoral) Summary: In our experience TAC XL used in conversion in stable renal transplants is safe, with stable renal function and proteinuria at two years. TAC XL shows a significant flexibility regarding different conversion strategies.
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