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J Clin Epidemiol. 2012 May;65(5):560-7. doi: 10.1016/j.jclinepi.2011.11.002.

Case-crossover design: an alternative strategy for detecting drug-induced liver injury.

Author information

1
Department of Public Health, Institute of Occupational Medicine and Industrial Hygiene, National Taiwan University College of Public Health, Room 733, 17 Syujhou Road, Taipei, Taiwan.

Abstract

OBJECTIVE:

Our observational study was conducted to assess if the case--crossover design could be applied to detect the risk of hepatoxic drugs on liver injury in the automated databases.

STUDY DESIGN AND SETTING:

The study was conducted on approximately 22 million people enrolled in Taiwan's National Health Insurance database from 1997 to 2004. We applied case--crossover and case--control designs to assess the estimated risks of liver injury related to well-known hepatoxic drugs, including isoniazid, rifampicin, erythromycin, and diclofenac. Using case--crossover and case--control designs, we analyzed to explore the association between hospitalization and our target drugs through a conditional logistic regression model.

RESULTS:

The adjusted odds ratios (ORs) of isoniazid, rifampicin, erythromycin, and diclofenac showed 24.4 (confidence interval [CI] =10.7-55.5), 30.8 (CI=14.1-67.1), 2.1 (CI=1.4-3.1), and 2.9 (CI=2.4-3.5) among 4,413 hospitalized liver injury patients during the 30-day exposure window by the case--crossover designs. Most adjusted ORs by case--crossover design were more conservative than ORs by case--control design.

CONCLUSIONS:

In addition to a case--control design, the case--crossover design is a suitable method, for detecting the potential hepatotoxicity of drugs.

PMID:
22445086
DOI:
10.1016/j.jclinepi.2011.11.002
[Indexed for MEDLINE]

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