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Definition and risk factors for chronicity following acute idiosyncratic drug-induced liver injury.

ABSTRACT: BACKGROUND & AIMS:Chronic outcome following acute idiosyncratic drug-induced liver injury (DILI) is not yet defined. This prospective, long-term follow-up study aimed to analyze time to liver enzyme resolutions to establish the best definition and risk factors of DILI chronicity. METHODS:298 out of 850 patients in the Spanish DILI registry with no pre-existing disease affecting the liver and follow-up to resolution or ?1year were analyzed. Chronicity was defined as abnormal liver biochemistry, imaging test or histology one year after DILI recognition. RESULTS:Out of 298 patients enrolled 273 (92%) resolved ?1year from DILI recognition and 25 patients (8%) were chronic. Independent risk factors for chronicity were older age [OR: 1.06, p=0.011], dyslipidemia [OR: 4.26, p=0.04] and severe DILI [OR: 14.22, p=0.005]. Alanine aminotransferase (ALT), alkaline phosphatase (ALP) and total bilirubin (TB) median values were higher in the chronic group during follow-up. Values of ALP and TB >1.1 x upper limit of normal (xULN) and 2.8 xULN respectively, in the second month from DILI onset, were found to predict chronic DILI (p<0.001). Main drug classes involved in chronicity were statins (24%) and anti-infectives (24%). Histological examination in chronic patients demonstrated two cases with ductal lesion and seven with cirrhosis. CONCLUSIONS:One year is the best cut-off point to define chronic DILI or prolonged recovery, with risk factors being older age, dyslipidemia and severity of the acute episode. Statins are distinctly related to chronicity. ALP and TB values in the second month could help predict chronicity or very prolonged recovery. LAY SUMMARY:Drug-induced liver injury (DILI) patients who do not resolve their liver damage during the first year should be considered chronic DILI patients. Risk factors for DILI chronicity are older age, dyslipidemia and severity of the acute episode. Chronic DILI is not a very common condition; normally featuring mild liver profile abnormalities and not being an important clinical problem, with the exception of a small number of cases of early onset cirrhosis.

SUBMITTER: Medina-Caliz I

PROVIDER: S-EPMC7458366 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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Definition and risk factors for chronicity following acute idiosyncratic drug-induced liver injury.

Medina-Caliz Inmaculada I Robles-Diaz Mercedes M Garcia-Muñoz Beatriz B Stephens Camilla C Ortega-Alonso Aida A Garcia-Cortes Miren M González-Jimenez Andres A Sanabria-Cabrera Judith A JA Moreno Inmaculada I Fernandez M Carmen MC Romero-Gomez Manuel M Navarro Jose M JM Barriocanal Ana M AM Montane Eva E Hallal Hacibe H Blanco Sonia S Soriano German G Roman Eva M EM Gómez-Dominguez Elena E Castiella Agustin A Zapata Eva M EM Jimenez-Perez Miguel M Moreno Jose M JM Aldea-Perona Ana A Hernández-Guerra Manuel M Prieto Martin M Zoubek Miguel E ME Kaplowitz Neil N Lucena M Isabel MI Andrade Raul J RJ

Journal of hepatology 20160513 3

<h4>Background & aims</h4>Chronic outcome following acute idiosyncratic drug-induced liver injury (DILI) is not yet defined. This prospective, long-term follow-up study aimed to analyze time to liver enzyme resolutions to establish the best definition and risk factors of DILI chronicity.<h4>Methods</h4>298 out of 850 patients in the Spanish DILI registry with no pre-existing disease affecting the liver and follow-up to resolution or ⩾1year were analyzed. Chronicity was defined as abnormal liver ...[more]

PMID: 27184533

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Project description:BackgroundAlthough fluoroquinolones are sometimes associated with mild, transient elevations in aminotransferase levels, serious acute liver injury is uncommon. Regulatory warnings have identified moxifloxacin as presenting a particular risk of hepatotoxicity. Thus, we examined the risk of idiosyncratic acute liver injury associated with the use of moxifloxacin relative to other selected antibiotic agents.MethodsWe conducted a population-based, nested, case-control study using health care data from Ontario for the period April 2002 to March 2011. We identified cases as outpatients aged 66 years or older with no history of liver disease, and who were admitted to hospital for acute liver injury within 30 days of receiving a prescription for 1 of 5 broad-spectrum antibiotic agents: moxifloxacin, levofloxacin, ciprofloxacin, cefuroxime axetil or clarithromycin. For each case, we selected up to 10 age- and sex-matched controls from among patients who had received a study antibiotic, but who were not admitted to hospital for acute liver injury. We calculated odds ratios (ORs) to determine the association between admission to hospital and previous exposure to an antibiotic agent, using clarithromycin as the reference.ResultsA total of 144 patients were admitted to hospital for acute liver injury within 30 days of receiving a prescription for one of the identified drugs. Of these patients, 88 (61.1%) died while in hospital. After multivariable adjustment, use of either moxifloxacin (adjusted OR 2.20, 95% confidence interval [CI] 1.21-3.98) or levofloxacin (adjusted OR 1.85, 95% CI 1.01-3.39) was associated with an increase in risk of acute liver injury relative to the use of clarithromycin. We saw no such risk associated with the use of either ciprofloxacin or cefuroxime axetil.InterpretationAmong older outpatients with no evidence of liver disease, moxifloxacin and levofloxacin were associated with an increased risk of acute liver injury relative to clarithromycin.

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Definition and risk factors for chronicity following acute idiosyncratic drug-induced liver injury.

Publications

Definition and risk factors for chronicity following acute idiosyncratic drug-induced liver injury.

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