Previous Drug Exposure in Patients Hospitalised for Acute Liver Injury: A Case-Population Study in the French National Healthcare Data System

Autor: M. Duong, Nicholas Moore, Vanessa Barbet, N. Thurin, Régis Lassalle, Sinem Ezgi Gulmez, S. Duret, A. Grolleau, Cécile Droz-Perroteau
Přispěvatelé: Grolleau, Adeline, CHU Bordeaux [Bordeaux], Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Bordeaux PharmacoEpi, Inserm CIC1401, Université de Bordeaux, Université de Bordeaux (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM), This study was supported by an unconditional public joint grant from Direction Générale de la Santé (DGS), from Mission recherche de la Direction de la recherche, des études, de l’évaluation et des statistiques (MiRe-DREES) of Caisse Nationale d’Assurance Maladie des Travailleurs Salariés (CNAMTS), Régime Social Indépendants (RSI) and Caisse Nationale de Solidarité́ pour l’Autonomie (CNSA), as part of the general call for projects by IReSP (Appel à Projets, Institut de Recherche en Santé Publique)., Cette recherche a bénéficié de l’aide conjointe de la Direction Générale de la Santé (DGS), de la Mission recherche de la Direction de la recherche, des études, de l’évaluation et des statistiques (MiRe-DREES) de la Caisse Nationale d’Assurance Maladie des Travailleurs Salariés (CNAMTS), du Régime Social des Indépendants (RSI) et de la Caisse Nationale de Solidarité pour l’Autonomie (CNSA), dans le cadre de l’appel à projets général lancé par l’IReSP (Institut de Recherche en Santé Publique).
Jazyk: angličtina
Rok vydání: 2018
Předmět:
Male
pharmacoepidemiology
Databases
Factual
Atorvastatin
Antibiotics
étude cas-population
Toxicology
030226 pharmacology & pharmacy
Esomeprazole
0302 clinical medicine
Pharmacology (medical)
030212 general & internal medicine
Omeprazole
media_common
base de données
education.field_of_study
Middle Aged
[SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences
3. Good health
Hospitalization
[SDV.SP] Life Sciences [q-bio]/Pharmaceutical sciences
Liver
Pharmaceutical Preparations
pharmacoépidémiologie
Population study
Chemical and Drug Induced Liver Injury
case-population
medicine.drug
Drug
medicine.medical_specialty
drug exposure
medicine.drug_class
media_common.quotation_subject
Population
Erythromycin
03 medical and health sciences
Internal medicine
medicine
Acute liver injury
Data Systems
Humans
education
Pharmacology
business.industry
claims database
[SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology
exposition médicamenteuse
[SDV.MHEP.HEG] Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology
hépatite aiguë
[SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie
[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie
business
Zdroj: Drug Safety
Drug Safety, Springer Verlag, In press, ⟨10.1007/s40264-018-0752-1⟩
ISSN: 0114-5916
DOI: 10.1007/s40264-018-0752-1
Popis: This is the accepted manuscript of this article.; International audience; Introduction: Acute liver injury (ALI) is a major reason for stopping drug development or removing drugs from the market. Hospitalisation for ALI is relatively rare for marketed drugs, justifying studies in large-scale databases such as the nationwide Système National des Données de Santé (SNDS) that covers 99% of the French population.Methods: SNDS was queried over 2010-2014 for all hospital admissions for acute toxic liver injuries not associated with a possible other cause, using a case-population approach. Exposures of interest were drugs dispensed from 7 to 60 days before date of admission. Individual drugs were analysed by their frequency (if ≥ 5 cases), and by the ratio of exposed cases to the number of exposed subjects and to exposed patient-time in the general population over the same time-frame.Results: Over 5 years, 4,807 cases of ALI were identified, mean age 54.5, 59% women, 76% exposed to at least one of 249 different drugs. Drugs most commonly identified were non-overdose paracetamol (31% of cases), esomeprazole or omeprazole (18%), phloroglucinol, domperidone, coamoxiclav, furosemide, atorvastatin (more than 250 cases each). When compared to population exposures, the highest per-person risks were observed with antimycobacterial antibiotics with 1 case for 1,000 or fewer users, followed by colestyramine and erythromycin (around 1/5,300), antiepileptic drugs, anticoagulants, anti-Alzheimer drugs (1/6,000 - 1/10,000 users). When a person-time approach is considered, the drugs with the highest per-tablet risk were still the antituberculosis drugs followed by a number of other antibiotics. Conclusions: This nationwide study describes drugs associated with ALI, according to absolute population burden, to per-patient and per-tablet risk. Some of these associations may be spurious, others causal, and others yet were unexpected. Systematic analysis of drug classes will look for outliers within each class that could raise signals of unexpected hepatic toxicity.
Databáze: OpenAIRE
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