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    Control Compounds for Preclinical Drug-Induced Liver Injury Assessment: Consensus-driven systematic review by the ProEuroDILI Network
    Research Square (Research Square) (2023)
    Antonio Segovia-ZafraMarina Villanueva-PazA.S. SerrasGonzalo Matilla‐CabelloAna Bodoque-GarcíaDaniel E. Di Zeo-SánchezHao NiuIsmael Álvarez‐ÁlvarezLaura Sanz‐VillanuevaSergej GodecIrina MilisavRaúl J. AndradeM. Isabel LucenaJosé Carlos Fernández ChecaFrancisco Javier CuberoJoana P. MirandaLeonard J. Nelson
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    Abstract:
    Abstract Idiosyncratic drug-induced liver injury (DILI) is a complex and unpredictable event caused by different drugs, herbal, and dietary supplements. The early identification of human hepatotoxicity at the preclinical stages remains a major challenge, in which the selection of validated in vitro systems and test drugs has a significant impact. This systematic review aims to analyse the compounds used in hepatotoxicity assays and establish a unified list of DILI positive and negative control drugs for validation of in vitro models of DILI, supported by literature and clinical evidence and endorsed by a committee of experts from the COST Action ProEuroDILI Network (CA 17112). This systematic review was performed in accordance with the 2020 PRISMA guidelines. Original research articles focused on investigating DILI occurrence using in vitro human models performing at least one hepatotoxicity assay with positive and negative control compounds were included. A modified version of the "Toxicological Data Reliability Assessment Tool" (ToxRTool) was used to assess the bias of the included studies. A total of 2,936 studies were retrieved from the different databases. Of these, 51 met the inclusion criteria, with 30 categorized as reliable without restrictions. Diclofenac and buspirone were the most commonly used DILI-positive and DILI-negative control drugs, respectively. Although there was a broad consensus on the positive compounds, the selection of negative control compounds remained less clear. Regarding the models used, the 2D monoculture of primary human hepatocytes (PHHs) was the favoured choice. However, there was no clear consensus on the drug concentrations. Short acute exposure times were mostly utilised, and cytotoxicity was the preferred endpoint. The extensive analysis of included studies highlighted the lack of agreement on appropriate control compounds for the in vitro assessment of DILI. Therefore, following comprehensive in vitro and clinical data analysis together with input from the expert committee, an evidence-based consensus-driven list of 10 positive and negative drugs is proposed for validating new in vitro models for improving preclinical drug safety testing regimes.
    Topics:
    Drug-Induced Hepatotoxicity and Protection
    Pharmacogenetics and Drug Metabolism
    Liver physiology and pathology
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    Drug-Induced Liver Injury — Types and Phenotypes
    New England Journal of Medicine (2019)
    Jay H. HoofnagleEinar S. Björnsson
    The liver has a range of responses to drug-induced injury, with a number of phenotypes. In addition, idiosyncratic reactions may occur as a consequence of both direct drug action and indirect drug effects. Antibiotics are the most common cause of drug-induced liver injury.
    Drug action
    Citations (507)
    Drug-induced liver injury: risk factors and drug development in DILI
    ˜The œbiomedical & life sciences collection. (2021)
    James H. Lewis
    Drug Development
    Citations (0)
    Comparison of search strategies in systematic reviews of adverse effects to other systematic reviews
    Health Information & Libraries Journal (2014)
    Su GolderYoon K. LokeLiliane Zorzela
    Abstract Background Research indicates that the methods used to identify data for systematic reviews of adverse effects may need to differ from other systematic reviews. Objectives To compare search methods in systematic reviews of adverse effects with other reviews. Methods The search methodologies in 849 systematic reviews of adverse effects were compared with other reviews. Results Poor reporting of search strategies is apparent in both systematic reviews of adverse effects and other types of systematic reviews. Systematic reviews of adverse effects are less likely to restrict their searches to MEDLINE or include only randomised controlled trials ( RCT s). The use of other databases is largely dependent on the topic area and the year the review was conducted, with more databases searched in more recent reviews. Adverse effects search terms are used by 72% of reviews and despite recommendations only two reviews report using floating subheadings. Conclusions The poor reporting of search strategies in systematic reviews is universal, as is the dominance of searching MEDLINE . However, reviews of adverse effects are more likely to include a range of study designs (not just RCT s) and search beyond MEDLINE .
    Citations (51)
    Drug-Induced Liver Injury
    Springer eBooks (2019)
    Bing RenArief A. SuriawinataMasaki Iwai
    Citations (13)
    Clinical Characteristics of 30 Cases of Acute Drug-induced Liver Injury
    Yong Chen
    Objective To analyze the clinical characteristics of acute drug-induced liver injury.Methods The causes,clinical characteristics,treatment and outcomes of 30 cases of acute drug-induced liver injury were analyzed retrospectively.Results The most common drug led to acute drug-induced liver injury was Chinese herbal medicine(11/30),accounting for 36.7%.Conclusion Acute drug-induced liver injury can be caused by a variety of drugs,and most caused by Chinese herbal medicine.
    Citations (0)
    Drug-induced Liver Injury:An Analysis of 371 Cases
    Zhongguo yiyuan yongyao pingjia yu fenxi (2009)
    Liu Weijun
    OBJECTIVE: To conduct a statistical analysis on 371 drug-induced liver injury cases for references of clinical rational drug use and drug safety evaluation.METHODS: In this retrospective study,a total of 371 drug-induced liver injury cases were analyzed with regard to patients' sex and age,medication,manifestation of side effects,and prognosis.RESULTS: A total of 12 categories(57 kinds) of drugs were involved in the 371 drug-induced liver injury cases,leading the first three places were all anti-tuberculosis drugs.CONCLUSION: Great attention should be attached to drug-induced liver injury to prevent adverse drug reactions.
    Adverse drug reaction
    Drug reaction
    Statistical Analysis
    Citations (0)
    Clinical analysis of 121 cases of drug-induced liver injury by antituberculosis drug
    Journal of clinical and experimental medicine (2010)
    Sha Hu
    Objective To investigate the clinical features,prevention and therapeutic measures of drug-induced liver injury by antituberculosis drug.Methods In 1 152 cases of tuberculosis patients in our hospital,121 cases had antituberculosis drug-induced liver injury.Drug-induced liver injury and its relation to age,initial treatment,retreatment and HBe infection were analyzed.Results The incidence of drug-induced liver injury was higher in patients ≥ 60-years-old,HBeAg + and undergoing retreatment than that in patients 60-years-old,HBeAg-and undergoing initial treatment (P0.001).The treatments of protecting liver,falling enzyme had good efficacy for recovering hepatic function.Conclusion Elderly,retreatment and HBe + are high-risk factors for drug-induced liver injury by antituberculosis drugs in tuberculosis patients.The hepatic function should be closely monitored in order to detect and treat drug-induced liver drug early and help patients complete antituberculosis chemotherapy.
    Liver function
    HBeAg
    Citations (0)
    Drug‐Induced Liver Injury
    Suzanne Sargent
    This chapter contains sections titled: Introduction Mechanisms of hepatotoxicity Diagnosis of drug-induced liver injury Classification of drug injury Commonly used drugs that cause hepatotoxicity Herbal remedies for treatment in liver disease Chapter summary Illustrative case study
    Liver disease
    Citations (14)
    Avoiding drug-induced liver injury
    Pharmacy Today (2019)
    Joey Sweeney
    Acetaminophen
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    Drug-induced Liver Injury - Tantangan dalamDiagnosis(Drug-induced Liver injury- Diagnostic Challenges)
    Imelda Maria LohoIrsan Hasan
    ABSTRACT Drug-induced liver injury or drug-related hepatotoxicity is injury to the liver caused by exposure to a drug or another noninfectious agent.The clinical signs could vary from very mild condition without any clinical symptoms to severe and life-threatening acute liver failure. Drug-related hepatotoxicity has a low reported incidence, ranging from 1 in 10.000 and in 100.000 patients, but its true incidence may pe higher because of difficulties in detection or diagnosis and underreporting. Key elements in assessing cause in the diagnosis of drug-related hepatotoxicity were: Eposure to a drug must precede the onset of liver injury. Other disease should be ruled out. Condition may improve when the drug is stopped and may recur more rapidly and severely on repeaxted exposure, especially if immunological process is involved. Key words: Drug-inducec liver injury. diagnosis, drug
    Liver disease
    Citations (0)