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P- 61 DRUG-INDUCED LIVER INJURY: REPORTING CHALLENGES AND ENZYMATIC CHANGES IN PATIENTS USING ANTIBIOTICS – RETROSPECTIVE STUDY
Nelson David Suarez, Raquel Boff, Vittoria Calvi, Paola Hoff, Sheila De Castro, Patricia Gabriela Riedel, Francielly Marques, Dvora Joveleviths
Programa de Pós-Graduação em Ciências em Gastroenterologia e Hepatologia, Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brasil
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        "resumen" => "<span id="abss0001" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0001">Introduction and Objectives</span><p id="spara001" class="elsevierStyleSimplePara elsevierViewall">Drug-induced liver injury &#40;DILI&#41; - an underreported adverse event &#40;AE&#41; - is classified as hepatocellular&#44; cholestatic or mixed&#44; through the alanine-aminotransferase &#40;ALT&#41; and alkaline phosphatase ratio&#44; when ALT &#62; 2x the upper limit of normal &#40;LSN&#41;&#46; Polypharmacy and conditions can change these data&#46; In hospitalized patients&#44; antibiotics &#40;ATB&#41; are one of the most prescribed drugs&#44; can cause DILI&#46; We aimed to evaluate the profile and frequency of ALT in patients using ATB amoxicillin-clavulanate &#40;AMX&#95;CLAV&#41;&#44; cefepime &#40;CEF&#41; and meropenem &#40;MPN&#41;&#44; verifying possibility and type of DILI&#44; notifications in the Hospital Pharmacovigilance System &#40;SFH&#41; and what limitations lead to underreporting&#46;</p></span> <span id="abss0002" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0002">Materials and Methods</span><p id="spara002" class="elsevierStyleSimplePara elsevierViewall">partial retrospective analysis of medical records of patients admitted to University Hospital&#44; with ALT&#62;2xLSN&#44; using the referred ATB&#59; AEs collection from the hospital and Anvisa databases&#44; assessing causes of underreporting&#46; Statistical significance was 5&#37; and analyzes were performed using SPSS&#174; program&#46;</p></span> <span id="abss0003" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0003">Results</span><p id="spara003" class="elsevierStyleSimplePara elsevierViewall">In 2018&#44; 739 hospitalized patients had ALT&#62;2xLSN&#46; Of these&#44; 45&#37; used ATB &#91;AMX&#95;CLAV &#40;2&#46;3&#37;&#41;&#59; CEF &#40;27&#46;2&#37;&#41;&#59; MPN &#40;15&#46;6&#41;&#93;&#46; Death in patients with ALT&#62;2xLSN was 40&#46;1&#37;&#44; majority CID A41&#46;9 &#40;27&#46;3&#37;&#41;&#46; K72&#46;0 &#91;Chronic Liver Failure&#93; scored 3&#46;5&#37;&#46; 24&#46;9&#37;&#40;n&#61;184&#41; had ALT&#62;5xULN and of these&#44; death in 53&#46;3&#37;&#40;n&#61;98&#41;&#40;p&#60;0&#46;001&#41;&#46; Use of CEF and MPN was significantly higher in deaths compared to non-deaths &#40;39&#46;9&#37; x 18&#46;7&#37;&#44; p&#60;0&#46;001&#47;27&#46;7&#37; x 7&#46;4&#37;&#44; p&#60;0&#46;001&#44; respectively CEF and NMP&#41;&#46; Concurrently&#44; SFH investigated 139 notifications&#44; 6&#46;5&#37; ATB AEs &#40;n&#61;9&#41;&#46; Of the cases&#44; 4 reported hepatotoxicity&#44; ALT being reported for MPN and AMX&#95;CLAV&#46; In ALT&#62;5xLSN patients&#44; there were 3 cholestatic &#40;3&#46;8&#37;&#41;&#44; 18 mixed &#40;60&#46;0&#37;&#41; and 3 hepatocellular &#40;13&#37;&#41;&#40;p&#60;0&#46;001&#41;&#46;</p></span> <span id="abss0004" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0004">Conclusions</span><p id="spara004" class="elsevierStyleSimplePara elsevierViewall">Hepatocellular injury in hospitalized patients with ALT&#62;5xULN using ATB is more severe&#44; although the mixed pattern is more frequent&#46; There is no active pharmacovigilance in DILI considering ALT&#59; spontaneous reports are underreported due to the complexity of the DILI diagnosis&#44; lack of specific tests and data in the medical records&#46;</p></span>"
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Article information
ISSN: 16652681
Original language: English
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