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Risk of acute liver injury associated with use of antibiotics. Comparative cohort and nested case–control studies using two primary care databases in Europe
Author(s) -
Brauer Ruth,
Douglas Ian,
Garcia Rodriguez Luis Alberto,
Downey Gerald,
Huerta Consuelo,
Abajo Francisco,
Bate Andrew,
Feudjo Tepie Maurille,
Groot Mark C. H.,
Schlienger Raymond,
Reynolds Robert,
Smeeth Liam,
Klungel Olaf,
Ruigómez Ana
Publication year - 2016
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.3861
Subject(s) - medicine , nested case control study , odds ratio , cohort , cohort study , antibiotics , poisson regression , logistic regression , pharmacoepidemiology , population , relative risk , case control study , database , pediatrics , confidence interval , environmental health , medical prescription , computer science , microbiology and biotechnology , pharmacology , biology
Purpose To assess the impact of varying study designs, exposure and outcome definitions on the risk of acute liver injury (ALI) associated with antibiotic use. Methods The source population comprised of patients registered in two primary care databases, in the UK and in Spain. We identified a cohort consisting of new users of antibiotics during the study period (2004–2009) and non‐users during the study period or in the previous year. Cases with ALI were identified within this cohort and classified as definite or probable, based on recorded medical information. The relative risk (RR) of ALI associated with antibiotic use was computed using Poisson regression. For the nested case–control analyses, up to five controls were matched to each case by age, sex, date and practice (in CPRD) and odds ratios (OR) were computed with conditional logistic regression. Results The age, sex and year adjusted RRs of definite ALI in the current antibiotic use periods was 10.04 (95% CI: 6.97–14.47) in CPRD and 5.76 (95% CI: 3.46–9.59) in BIFAP. In the case–control analyses adjusting for life‐style, comorbidities and use of medications, the OR of ALI for current users of antibiotics was and 5.7 (95% CI: 3.46–9.36) in CPRD and 2.6 (95% CI: 1.26–5.37) in BIFAP. Conclusion Guided by a common protocol, both cohort and case–control study designs found an increased risk of ALI associated with the use of antibiotics in both databases, independent of the exposure and case definitions used. However, the magnitude of the risk was higher in CPRD compared to BIFAP. Copyright © 2016 John Wiley & Sons, Ltd.