Number of Subjects in Study Archive: 115 unique subjects (June 2013)
Study Design: Observational
Conditions: Drug-Induced Liver Injury, Liver Diseases
Division: DDN
# Recruitment Centers: 6
Treatment: None
Available Genotype Data: No
Image Summary: No
Transplant Type: None
Does it have dialysis patients: No
Clinical Trials URL:
https://clinicaltrials.gov/ct2/show/NCT00360646
Study Website: https://dilin.org/for-practitioners/retrospective-study/about-the-retrospective-study/
Data Package Version Number: 3 (Updated on: December 18, 2017)
DOI: 10.58020/2v81-5f48
How to cite this dataset: Barnhart, Huiman (2023). DILIN: Retrospective (V3) [Dataset]. NIDDK Central Repository. https://doi.org/10.58020/2v81-5f48
Data availability statement: Data from the DILIN: Retrospective [(V3)/https://doi.org/10.58020/2v81-5f48] reported here are available for request at the NIDDK Central Repository (NIDDK-CR) website, Resources for Research (R4R), https://repository.niddk.nih.gov/.
Drug-induced liver injury (DILI) is the single most common reason for regulatory actions concerning drugs, including failure to gain approval for marketing, removal from the market place, and restriction of prescribing indications. DILI is also a significant cause of morbidity and mortality in many patient populations. To stimulate and facilitate research into DILI, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has recently established the Drug-Induced Liver Injury Network (DILIN). One of the initial projects to be conducted by the network is to retrospectively establish a nationwide registry of patients who have suffered severe idiosyncratic liver injury associated with drugs (ILIAD), and to collect, and store serum, DNA from these patients (hereafter referred to as the “ILIAD protocol”). This ILIAD protocol will serve as a resource for subsequent mechanistic investigations of the basis for susceptibility to severe idiosyncratic DILI.
Data from the DILIN Retrospective study through the grant 3 cycle (2018) are available from the Repository.
The primary goal of the ILIAD protocol is to create: (a) a clinical database consisting of individuals who have experienced severe DILI caused by seven specific drugs (isoniazid, phenytoin, clavulanic acid / amoxicillin and valproic acid, nitrofurantoin, trimethoprim-sulfamethoxazole, minocycline) and one drug class (quinolone antibiotics); and, (b) to create a bank of biological specimens obtained from these individuals. These biological specimens will be DNA, plasma. A secondary goal of the ILIAD protocol is to maintain a registry of cases in the ILIAD database so that they may be re-contacted in the future. It is expected that this will facilitate additional studies exploring the mechanisms of DILI.
An important goal of this study is to generate hypotheses for consideration in future studies. Type-II error, i.e., failing to find an interesting association when there is one, is an important consideration. Thus, as a compromise between type-I and type-II error, α = 0.01 will be applied to declare any effect statistically significant. Because the suspected DILI mechanism is thought to be different for each drug, statistical analysis will be performed separately for each medication. The conditional logistic regression model will be the primary analytic model. Stratification variables, and any other covariates (other than the matching variables) known or suspected to distinguish cases from controls will be included as covariates. The adjusted odds ratio, together with its confidence interval, will be estimated from the associated regression parameters. Supplementary analyses as described in Liang and Zeger will be applied using a generalized linear mixed model approach.
To be included in the ILIAD registry, the following criteria must be satisfied: