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Pharmacoepidemiology of tacrolimus in pediatric liver transplantation
Author(s) -
Riva Natalia,
Schaiquevich Paula,
Cáceres Guido Paulo,
Halac Esteban,
Dip Marcelo,
Imventarza Oscar
Publication year - 2017
Publication title -
pediatric transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.457
H-Index - 69
eISSN - 1399-3046
pISSN - 1397-3142
DOI - 10.1111/petr.12982
Subject(s) - medicine , tacrolimus , liver transplantation , nephrotoxicity , cohort , transplantation , calcineurin , gastroenterology , surgery , toxicity
Abstract AE s during immunosuppressive treatment with tacrolimus are very common. We retrospectively evaluated FK safety and efficacy in a large pediatric liver transplant cohort in Latin America. During 2‐year follow‐up, we analyzed data from patients who underwent liver transplantation over the period 2010‐2012 and recorded FK exposure, AE s, and AR episodes. AE s were classified according causality and severity. Tacrolimus exposure before and during AE was compared using Wilcoxon matched‐pairs test. Kaplan‐Meier curves were used for survival analysis. In total, 46 patients (out of 72 patients) experienced 69 AE s, such as hypomagnesemia (49%), PTLD (6%), hypertension (6%), and/or nephrotoxicity (22%). 43% of AE s were classified as moderate or serious, and 89% were assigned as probable or definitive. Patients who had one or more AR episodes accounted for 65%. The 12‐month acute rejection‐free survival was 41% (95% CI , 30.1%‐53.1%). A significant difference was observed in FK trough concentrations before and during hypomagnesemia and nephrotoxicity ( P <.05). This study is the first report of FK safety in a large group of pediatric liver transplant patients in Latin America. Children experience AE s, even in protocols with low FK doses. Therapeutic monitoring is an important tool to manage immunosuppressive schemes containing tacrolimus in vulnerable populations.