Avaliação da tolerabilidade do micofenolato de sódio com revestimento entérico em receptores de transplante renal

• Ano de defesa: 2016
• Autor(a) principal: Hiramoto, Liliane Lumi [UNIFESP]
• Tipo de documento: Dissertação
• Tipo de acesso: Acesso aberto
• Idioma: por
• Instituição de defesa: Universidade Federal de São Paulo (UNIFESP)
• Palavras-chave em Português: Immunosuppression; Transplant; Mycophenolate sodium enteric-coated; Tolerability; Imunossupressão; Transplante; Micofenolato sódico com revestimento entérico; Tolerabilidade
• Link de acesso: https://sucupira.capes.gov.br/sucupira/public/consultas/coleta/trabalhoConclusao/viewTrabalhoConclusao.jsf?popup=true&id_trabalho=4814339; http://repositorio.unifesp.br/handle/11600/47042

Introduction: The enteric coated mycophenolate sodium (EC-MPS) is an antiproliferative prodrug which acts in the biosynthesis of purines. A major limitation of the EC-MPS is the occurrence of gastrointestinal adverse events mostly. Thus, the modification of EC-MPS dose may be sufficient to relieve symptoms, but can result in subtherapeutic levels and increase the risk of acute rejection. Objectives: This study aims to evaluate the EC-MPS tolerability associated with TAC and PRED in renal transplant recipients. Methods: A retrospective study of a cohort of kidney transplants with living or deceased donors made between 01/01/2007 and 31/12/2011 at the Hospital do Rim to evaluate the tolerability of the EC-MPS and classification into five subgroups according to type of modification made (temporary reduction, definitive reduction, temporary interruption, definitive interruption and without modification). Results: The modification-free survival dose of EC-MPS was 49.8%. According to CTCAE, the gastrointestinal system had the highest incidence and was observed at all dose modification subgroups, with an incidence of 50% to TR, 47.3% for DR, 46.8% for TI and 37.0% for the subgroup DI. The main adverse events reported were diarrhea, CMV infection, and leukopenia. Secondary endpoints of incidence of BPAR were worse for the DI subgroup when compared to the others (DI 46.3% vs TR 28.6% vs DR 41.1% vs WM 25.8%; p <0.05). Conclusion: 50.2% of patients did not tolerate the use of EC-MPS and the three main causes of dose changes were gastrointestinal, infections and infestations and hematological changes. The adverse event of diarrhea was observed in over 37% of cases in all subgroups. The subgroup DI showed poor graft survival (44.4%) and patients survival (59.3%), and 40.9% of the patients had the infection as the main factor of drug discontinuation. In addition, the DI subgroup showed higher incidence of BPAR (46.3%) when compared to WM subgroup (25.8%), which may be associated with increased incidence of infectious adverse events type.