Disproportionality analysis using empirical Bayes data mining: a tool for the evaluation of drug interactions in the post-marketing setting

被引:81
作者
Almenoff, JS
DuMouchel, W
Kindman, LA
Yang, XH
Fram, D
机构
[1] GlaxoSmithKline R&D, Global Clin Safety & Pharmacovigilance, Res Triangle Pk, NC 27709 USA
[2] AT&T Res, Murray Hill, NJ USA
关键词
D O I
10.1002/pds.885
中图分类号
R1 [预防医学、卫生学];
学科分类号
1004 ; 120402 ;
摘要
In summary, the results of this study suggest that disproportionality analysis using empirical Bayes data mining is a promising tool for investigating the clinical relevance of potential drug interactions. By studying drugs with well-known safety profiles, we were able to correlate the results with the well-established pharmacologic effects of these drugs and verify the reliability of the approach. The predictive value of this method will depend on many factors, including the seriousness of the adverse event, which may affect how frequently it is reported. Hence, results must be interpreted with caution, and if possible, validated with case review. Further confirmation of a cause-effect relationship between drug combination and AE pairs would require independent testing using clinical pharmacology studies or clinical trials.
引用
收藏
页码:517 / 521
页数:5
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