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
相关论文
共 15 条
  • [1] ALAWI A, 2002, AM J CARDIOL, V89, P1308
  • [2] DuMouchel W, 1999, AM STAT, V53, P177, DOI 10.2307/2686093
  • [3] DUMOUCHEL W, 2001, EMPIRICAL BAYES SCRE
  • [4] Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports
    Evans, SJW
    Waller, PC
    Davis, S
    [J]. PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2001, 10 (06) : 483 - 486
  • [5] Improving recognition of drug interactions - Benefits and barriers to using automated drug alerts
    Glassman, PA
    Simon, B
    Belperio, P
    Lanto, A
    [J]. MEDICAL CARE, 2002, 40 (12) : 1161 - 1171
  • [6] A retrospective evaluation of a data mining approach to aid finding new adverse drug reaction signals in the WHO International Database
    Lindquist, M
    Ståhl, M
    Bate, A
    Edwards, IR
    Meyboom, RHB
    [J]. DRUG SAFETY, 2000, 23 (06) : 533 - 542
  • [7] DRUG-INTERACTIONS AND THE PREPARED OBSERVER
    MELMON, KL
    NIERENBERG, DW
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 1981, 304 (12) : 723 - 725
  • [8] DIFFERENTIAL CARDIOVASCULAR EFFECTS OF CALCIUM-CHANNEL BLOCKING-AGENTS - POTENTIAL MECHANISMS
    MILLARD, RW
    LATHROP, DA
    GRUPP, G
    ASHRAF, M
    GRUPP, IL
    SCHWARTZ, A
    [J]. AMERICAN JOURNAL OF CARDIOLOGY, 1982, 49 (03) : 499 - 506
  • [10] ELECTRO-PHYSIOLOGICAL ACTIONS OF CALCIUM-ANTAGONISTS IN THE HEART
    SEIPEL, L
    BREITHARDT, G
    [J]. CARDIOLOGY, 1982, 69 : 105 - 116