Utilization of chi-square statistics for screening adverse drug-drug interactions in spontaneous reporting systems.

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Utilization of chi-square statistics for screening adverse drug-drug interactions in spontaneous reporting systems.

Utilization of chi-square statistics for screening adverse drug-drug interactions in spontaneous reporting systems.

アブストラクト	PURPOSE: We proposed a statistical criterion to detect drug-drug interactions causing adverse drug reactions in spontaneous reporting systems. METHODS: The used criterion quantitatively measures the discrepancy between the observed and expected number of adverse events via chi-square statistics. We compared the performance of our method with that of Noren et al. (Stat Med 2008; 27 (16): 3057-3070) through a simulation study. RESULTS: When the number of events for a combination of two drugs was equal to or lower than two, the false positive rate for our method ranged from 0.01 to 0.08, whereas the rate for Noren's method ranged from 0.01 to 0.06. The sensitivity for our method ranged from 0.09 to 0.29, whereas the sensitivity for Noren's method ranged from 0.03 to 0.24. The area-under-the-receiver operating characteristic curve for our method was significantly larger than that for Noren's methods regardless of simulation settings. The proposed method was also applied to the Food and Drug Administration Adverse Event Reporting System database, and a recognized drug-drug interaction was detected. CONCLUSIONS: The proposed criterion controlled false positives at an acceptable level and had higher sensitivity than that of Noren's method had when events were rare.
ジャーナル名	European journal of clinical pharmacology
Pubmed追加日	2017/3/11
投稿者	Gosho, Masahiko; Maruo, Kazushi; Tada, Keisuke; Hirakawa, Akihiro
組織名	Department of Clinical Trial and Clinical Epidemiology, Faculty of Medicine,;University of Tsukuba, 1-1-1, Tennodai, Tsukuba, Ibaraki, 305-8575, Japan.;mgosho@md.tsukuba.ac.jp.;Department of Clinical Epidemiology, Translational Medical Center, National;Center of Neurology and Psychiatry, 4-1-1 Ogawa-Higashi, Kodaira, Tokyo,;187-8551, Japan.;Biostatistics & Programming, Sanofi K. K, Tokyo Opera City Tower, 3-20-2, Nishi;Shinjuku, Tokyo, 163-1488, Japan.;Center for Advanced Medicine and Clinical Research, Nagoya University Hospital,;65 Tsurumai-cho, Showa-ku, Nagoya, 466-8560, Japan.
Pubmed リンク	https://www.ncbi.nlm.nih.gov/pubmed/28280890/