2010 - TTS International Congress
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Clinical Immunosuppression Kidney early
22.11 - short-term clinical result to use of extended release tacrolimus in kidney transplant recipients
Presenter: Jesus, Bustamante Bustamante, Valladolid, Spain
Authors: Pascual Núñez P., Sanz Ballesteros S., Mendiluce Herrero A., Bustamante Bustamante J.
SHORT-TERM CLINICAL RESULT TO USE OF EXTENDED RELEASE TACROLIMUS IN KIDNEY TRANSPLANT RECIPIENTS
CLINICAL IMMUNOSUPPRESSION - KIDNEY EARLY
P. Pascual núñez, S. Sanz ballesteros, A. Mendiluce herrero, J. Bustamante bustamante
Nephrology, Hospital Clinico Universitario, valladolid/SPAIN
Body:
| Body: Tacrolimus extended release formulation has been developed to enable once daily dosing to improve compliance. The aim of this study is to know the results of use of extended release tacrolimus (XL) during the first posttrasnsplant year, the incidence of adverse events and to assess kidney function. Methods: We studied 30 patients, follow up the first year. All subjects received XL-Tacrolimus (0.22 mg / kg), Basiliximab, and corticosteroids; and mycophenolate mofetil, only those with high risk of rejection. We analyzed the characteristics of the donor and recipient, pretransplant cardiovascular risk factors and kidney function, levels of immunosuppressive therapy, incidence of acute rejection, side effects and adverse events related to XL-Tacrolimus. Results: 76% were male and 24% women. The mean age was 57.8 years. Seven cases (28%) were a second transplant. Before trasplant, 92% of patients had Hypertension and 16% Diabetes Mellitus. The mean doses of XL-Tacrolimus were 0.22mg/kg at 7 days, 0.19 mg / kg at 30 days, 0.15mg/kg at 3 months, and 0,046 mg/kg at 6 and 12 months, to achieve target blood levels according to our protocol. The incidence of acute tubular necrosis was 20% and of acute rejection 8%; there were 4 cases of infection (13%) for Varicella-Zoster Virus and 25 cases of urinary tract infection, most of them were slights, 1 pielonephrytis and 1 urinary tuberculosis. There were not serious adverse events related to tacrolimus XL, but 36% of patients developed hyperkalemia during fisrt 3 posttransplant months and only 10% at 6-12 months, and 44% hyperuricemia at first 3 month and 23% after three months until 1 year. Both effects seem to relate to elevated levels of XL-Tacrolimus. The mean serum creatinine was 2.3 mg/dl at 7 days, 1.8mg/dl at 30days and 1.9mg/dl at three months, and 1,42mg/dl at 12 months. The most frequent side effect was a tremor (48%). 3 patients present nephrotoxicity and they were changed by everolimus. There were 13% posttrasplantation Diabetes mellitus. One-year patient and graft survival were 100%. Conclusions: The XL-tacrolimus was, in general, well tolerated, although we found a high incidence of hyperkalemia, and hyperuricemia, more important in 3 firts months associated with high levels of the drug. To improve these results we should extend the study, both in number of patients and follow-up. |
Disclosure: All authors have declared no conflicts of interest.
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