著者
梅津 亮冴 西端 友里 阿部 純子 鈴木 悠起也 原 英彰 永澤 秀子 紀ノ定 保臣 中村 光浩
出版者
公益社団法人 日本薬学会
雑誌
YAKUGAKU ZASSHI (ISSN:00316903)
巻号頁・発行日
vol.134, no.2, pp.299-304, 2014 (Released:2014-02-01)
参考文献数
22
被引用文献数
11 17

Hypoglycemia due to treatment with oral anti-hyperglycemic agents (OHAs) is a major clinical problem in patients with type 2 diabetes mellitus. The aim of the present study was to evaluate the risk of hypoglycemia due to OHA use by using the Japanese Adverse Drug Event Report (JADER) database. To this end, reports of hypoglycemia events included in the JADER database between 2004 and 2012 were analyzed by calculating the reporting odds ratio (OR). The Medical Dictionary for Regulatory Activities Preferred Terms was used to identify hypoglycemia; 254392 reports were found in the JADER database, of which 13269 were excluded because the age and sex of the patient were not reported. Finally, 241123 reports were analyzed. Among OHAs, sulfonylureas showed the highest adjusted OR (adjusted OR, 10.13; 95% confidence interval, 9.08-11.26). The adjusted ORs for meglitinides, biguanide, thiazolidinedione, alpha-glucosidase inhibitors, and dipeptidyl peptidase-4 inhibitors were significantly lower than that of sulfonylureas. The adjusted OR of meglitinides (3.17; 95% confidence interval, 2.23-4.36) was significantly higher than that of alpha-glucosidase inhibitors or thiazolidinedione. We observed no difference between the adjusted ORs for biguanide, thiazolidinedione, alpha-glucosidase inhibitors, and dipeptidyl peptidase-4 inhibitors. Data mining of the JADER database was useful for analyzing OHA-associated hypoglycemia events. The results of our study suggested a low risk of hypoglycemia associated with biguanide, thiazolidinedione, alpha-glucosidase inhibitors, and dipeptidyl peptidase-4 inhibitors in clinical practice.
著者
相川 慎也 芦原 貴司 天野 晃 有末 伊織 安藤 譲二 伊井 仁志 出江 紳一 伊東 保志 稲田 慎 井上 雅仁 今井 健 岩下 篤司 上村 和紀 内野 詠一郎 宇野 友貴 江村 拓人 大内田 研宙 大城 理 太田 淳 太田 岳 大谷 智仁 大家 渓 岡 崇史 岡崎 哲三 岡本 和也 岡山 慶太 小倉 正恒 小山 大介 海住 太郎 片山 統裕 勝田 稔三 加藤 雄樹 加納 慎一郎 鎌倉 令 亀田 成司 河添 悦昌 河野 喬仁 紀ノ定 保臣 木村 映善 木村 真之 粂 直人 藏富 壮留 黒田 知宏 小島 諒介 小西 有人 此内 緑 小林 哲生 坂田 泰史 朔 啓太 篠原 一彦 白記 達也 代田 悠一郎 杉山 治 鈴木 隆文 鈴木 英夫 外海 洋平 高橋 宏和 田代 洋行 田村 寛 寺澤 靖雄 飛松 省三 戸伏 倫之 中沢 一雄 中村 大輔 西川 拓也 西本 伸志 野村 泰伸 羽山 陽介 原口 亮 日比野 浩 平木 秀輔 平野 諒司 深山 理 稲岡 秀検 堀江 亮太 松村 泰志 松本 繁巳 溝手 勇 向井 正和 牟田口 淳 門司 恵介 百瀬 桂子 八木 哲也 柳原 一照 山口 陽平 山田 直生 山本 希美子 湯本 真人 横田 慎一郎 吉原 博幸 江藤 正俊 大城 理 岡山 慶太 川田 徹 紀ノ岡 正博 黒田 知宏 坂田 泰史 杉町 勝 中沢 一雄 中島 一樹 成瀬 恵治 橋爪 誠 原口 亮 平田 雅之 福岡 豊 不二門 尚 村田 正治 守本 祐司 横澤 宏一 吉田 正樹 和田 成生
出版者
公益社団法人 日本生体医工学会
雑誌
生体医工学 (ISSN:1347443X)
巻号頁・発行日
vol.Dictionary.1, pp.1-603, 2022 (Released:2022-03-31)
著者
笹岡 沙也加 松井 利亘 阿部 純子 梅津 亮冴 加藤 大和 上田 夏実 羽根 由基 元岡 佑美 畠平 春奈 紀ノ定 保臣 中村 光浩
出版者
公益社団法人 日本薬学会
雑誌
YAKUGAKU ZASSHI (ISSN:00316903)
巻号頁・発行日
vol.136, no.3, pp.507-515, 2016-03-01 (Released:2016-03-01)
参考文献数
27
被引用文献数
11 14

The Japanese Ministry of Health, Labor, and Welfare lists hand-foot syndrome as a serious adverse drug event. Therefore, we evaluated its association with anticancer drug therapy using case reports in the Japanese Adverse Drug Event Report (JADER) and the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). In addition, we calculated the reporting odds ratio (ROR) of anticancer drugs potentially associated with hand-foot syndrome, and applied the Weibull shape parameter to time-to-event data from JADER. We found that JADER contained 338224 reports from April 2004 to November 2014, while FAERS contained 5821354 reports from January 2004 to June 2014. In JADER, the RORs [95% confidence interval (CI)] of hand-foot syndrome for capecitabine, tegafur-gimeracil-oteracil, fluorouracil, sorafenib, and regorafenib were 63.60 (95%CI, 56.19-71.99), 1.30 (95%CI, 0.89-1.89), 0.48 (95%CI, 0.30-0.77), 26.10 (95%CI, 22.86-29.80), and 133.27 (95%CI, 112.85-157.39), respectively. Adverse event symptoms of hand-foot syndrome were observed with most anticancer drugs, which carry warnings of the propensity to cause these effects in their drug information literature. The time-to-event analysis using the Weibull shape parameter revealed differences in the time-dependency of the adverse events of each drug. Therefore, anticancer drugs should be used carefully in clinical practice, and patients may require careful monitoring for symptoms of hand-foot syndrome.
著者
梅津 亮冴 阿部 純子 上田 夏実 加藤 大和 中山 蓉子 紀ノ定 保臣 中村 光浩
出版者
公益社団法人 日本薬学会
雑誌
YAKUGAKU ZASSHI (ISSN:00316903)
巻号頁・発行日
vol.135, no.8, pp.991-1000, 2015 (Released:2015-08-01)
参考文献数
19
被引用文献数
3 7

Over-the-counter (OTC) drugs play an important role in self-medication. To ensure patient safety, pharmacists should ask patients to pay attention to possible adverse events (AE) associated with OTC drugs and educate patients about the symptoms related to those AEs. The aims of the present study were as follows: (1) to assess the tendency of AEs to occur with OTC drug use in Japan; (2) to detect a safety signal for OTC drugs using the reporting odds ratio (ROR); and (3) to evaluate clustery features, which include suspected drugs and therapeutic classifications, and safety signal indices (number of reports and the ROR), using cluster analysis. The number of reports of AEs following use of combination cold remedy, antipyretic and analgesic remedy, and herbal medicine was 1007, 566, and 221, respectively. We set the cluster number at five; clustery features obtained were as follows: (1) high reporting rate for skin and subcutaneous tissue disorder AEs was the largest group related to combination cold remedy; (2) high reporting rate for nervous system disorder AEs including dizziness was the second largest group. The same medicinal ingredient may demonstrate similar tendencies of the occurrence of AEs and similar clustery features in the Japanese Adverse Drug Event Report database. Our analysis of AEs associated with OTC drugs may be useful for pharmacists and patients alike. Further studies are required to draw better-informed conclusions.