医療薬学
Online ISSN : 1882-1499
Print ISSN : 1346-342X
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有害事象自発報告データベースに基づくスタチン系薬剤による耐糖能異常新規発症リスクに関する研究
畠平 春奈松井 利亘加藤 大和上田 夏実阿部 純子笹岡 沙也加元岡 佑美羽根 由基紀ノ定 保臣後藤 千寿中村 光浩
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2016 年 42 巻 2 号 p. 98-106

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Recent reports indicate that statin therapy is associated with a high risk of developing diabetes mellitus. The aim of this study was to evaluate the effect of statins on impaired glucose tolerance. Spontaneous reporting systems, such as the Food and Drug Administration Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report (JADER) database, are used for pharmacovigilance studies. We evaluated the association between each drug and adverse event on the basis of the number of cases and reporting odds ratio (ROR), and Weibull distribution parameter for the time-to-onset analysis. FAERS contained 5,821,716 reports, and after excluding duplicate data, 4,551,642 reports were analyzed. The number of reports related to impaired glucose tolerance was 388,668. The RORs of impaired glucose tolerance events for atorvastatin, rosuvastatin, simvastatin, pravastatin, fluvastatin, and pitavastatin were 2.9 (95% confidence interval [CI]: 2.8-2.9), 1.6 (1.5-1.7), 0.9 (0.8-0.9), 0.9 (0.8-1.0), 1.3 (1.0-1.6), and 1.2 (0.6-2.4), respectively. The RORs from this database indicate that impaired glucose tolerance is likely associated with atorvastatin and rosuvastatin use. The JADER database contained 338,224 reports. The median time-to-onset of impaired glucose tolerance for atorvastatin, rosuvastatin, simvastatin, pravastatin, fluvastatin, and pitavastatin use was 144, 35, 123, 308, 304, and 370 days, respectively. Since the shape parameter β of Weibull distribution for all statins was less than 1, hazard was considered to decrease over time that are classified as early failure type. Our results emphasize the need for clinicians to closely monitor impaired glucose tolerance in patients receiving statins.

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