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Ren Fail ; 30(6): 629-38, 2008.
Artigo em Inglês | MEDLINE | ID: mdl-18661414

RESUMO

The relative safety of parenteral iron preparations is a controversial issue in the management of anemia in chronic kidney disease (CKD), as direct head-to-head comparative trials are lacking. In this study, patients of CKD were randomized to receive intravenous low molecular weight iron dextran (ID), sodium ferrigluconate complex (SFGC), and iron sucrose (IS) at doses and infusion rates recommended by the product manufacturer. One time test dose was used only for ID and SFGC. A total of 2,980 injections (n = 339) of i.v. iron was given, and 49 patients (14.45% per patient) and a total of 56 adverse events (1.88% per infusion) were noted. Odds ratios (OR) of serious adverse drug events (ADE; i.e., death, anaphylaxis, or suspected immuno-allergic events) per patient was not significant between ID vs. SFGC (3.566) and SFGC vs. IS (2.129), whereas that between ID vs. IS (7.594) was highly significant (p = 0.034). OR of serious ADE exposure was significantly higher in ID vs. SFGC (OR = 5.670, p = 0.0147) and ID vs. IS (OR = 7.799, p < 0.001). No significant difference was seen between the three groups in terms of non-serious ADEs. Drug discontinuation occurred significantly more often with ID. One patient who developed anaphylactoid reaction with SFGC and ID tolerated iron sucrose well.


Assuntos
Anemia Ferropriva/tratamento farmacológico , Anemia Ferropriva/etiologia , Compostos Férricos/efeitos adversos , Complexo Ferro-Dextran/efeitos adversos , Falência Renal Crônica/complicações , Adulto , Fatores Etários , Análise de Variância , Anemia Ferropriva/diagnóstico , Relação Dose-Resposta a Droga , Esquema de Medicação , Feminino , Compostos Férricos/administração & dosagem , Óxido de Ferro Sacarado , Seguimentos , Ácido Glucárico , Humanos , Infusões Intravenosas , Complexo Ferro-Dextran/administração & dosagem , Falência Renal Crônica/terapia , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Probabilidade , Diálise Renal/efeitos adversos , Diálise Renal/métodos , Medição de Risco , Índice de Gravidade de Doença , Fatores Sexuais , Resultado do Tratamento
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