医療薬学
Online ISSN : 1882-1499
Print ISSN : 1346-342X
ISSN-L : 1346-342X
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日本の有害事象自発報告データベース(JADER)を用いたアンジオテンシン受容体拮抗薬/ヒドロクロロチアジド配合薬における有害事象の解析
野口 義紘江﨑 宏樹浅野 祥子横井 貴文臼井 一将加藤 未紗齊藤 康介舘 知也寺町 ひとみ
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2015 年 41 巻 5 号 p. 347-354

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In cases of combination therapy, it is deemed that patients receiving a large amount of oral medication do not adhere to instructions from their physicians. Since 2006, fixed-dose combination (FDC) of hypertension agents has been innovated in practice to improve patients' medication adherence. Even though FDC therapy has had remarkable effects on hypertension, there are concerns about harmful interactions between each of the drugs. The aim of our study is to reveal the adverse events of FDC of angiotensin receptor antagonist (ARB) and hydrochlorothiazide (HCTZ).
We analyzed adverse events using data from the Japanese Adverse Drug Event Report database (JADER) from April 2004 to September 2013. The adverse events surveyed were hypokalemia, hyperkalemia, hyponatremia and hyperuricemia. We calculated the Reporting Odds Ratio (ROR) from the number of reports that were extracted from the database and evaluated.
During the period analyzed, 285,992 adverse events were reported to JADER; 270,491 items (94.6%), excluding ambiguous data or missing data, age and gender, were used in the analysis.
A signal was detected for all the adverse events that were included in this study. Therefore, there is considered to be a need to monitor the clinical laboratory values, such as electrolyte levels, for patients taking ARB/HCTZ FDC.

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© 2015 日本医療薬学会
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