2015 年 41 巻 5 号 p. 347-354
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.