著者

大山 勝宏 井上 みち子

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.7, pp.1065-1071, 2016 (Released:2016-07-01)

参考文献数

35

被引用文献数

5

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Selective beta-adrenergic drugs are used clinically to treat various diseases. Because of imperfect receptor selectivity, beta-adrenergic drugs cause some adverse drug events by stimulating other adrenergic receptors. To examine the association between selective beta-adrenergic drugs and blood pressure elevation, we reviewed the Japanese Adverse Drug Event Reports (JADERs) submitted to the Japan Pharmaceuticals and Medical Devices Agency. We used the Medical Dictionary for Regulatory Activities (MedDRA) Preferred Terms extracted from Standardized MedDRA queries for hypertension to identify events related to blood pressure elevation. Spontaneous adverse event reports from April 2004 through May 2015 in JADERs, a data mining algorithm, and the reporting odds ratio (ROR) were used for quantitative signal detection, and assessed by the case/non-case method. Safety signals are considered significant if the ROR estimates and lower bound of the 95% confidence interval (CI) exceed 1. A total of 2021 reports were included in this study. Among the nine drugs examined, significant signals were found, based on the 95%CI for salbutamol (ROR: 9.94, 95%CI: 3.09-31.93) and mirabegron (ROR: 7.52, 95%CI: 4.89-11.55). The results of this study indicate that some selective beta-adrenergic drugs are associated with blood pressure elevation. Considering the frequency of their indications, attention should be paid to their use in elderly patients to avoid adverse events.

著者

大山 勝宏 清水 万紀子 山崎 浩史

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.40, no.5, pp.310-316, 2014-05-10 (Released:2015-05-10)

参考文献数

18

被引用文献数

1 1

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A retrospective survey of a database containing patient backgrounds and prescribed drugs was conducted to elucidate the detailed characteristics and risk factors of adverse effects caused by topical dermatological formulations of diclofenac. A total of 145,478 patients who had been dispensed topical dermatological formulations of diclofenac at 466 community pharmacies belonging to Nihon Chouzai were included in the study. Of these, 580 patients had adverse effects. The incidence of adverse effects was significantly higher in the elderly (more than 65 years old) and in female patients. A variety of systemic adverse effects were evident in 19 patients. Approximately half of these adverse effects were related to the respiratory system, eg, asthma, but the other adverse effects (eg, edema, decreases in urinary volume, tremor and others) were not described in the drug package inserts. Data from patients with systemic adverse effects, and an age- and gender-matched control group of patients underwent multivariate logistic regression analysis. Asthma (odds ratio: 13.3, 95% confidence interval: 2.40 - 95.5, P = 0.004) and the number of co-administered drugs (odds ratio: 1.25, 95% confidence interval: 1.02 - 1.55, P = 0.035) were identified as risk factors for systemic adverse effects of topical dermatological formulations of diclofenac. Moreover, many of the co-administered drugs affected P450 enzymes other than P450 2C9, the main metabolizer of diclofenac. Therefore, to manage the risk of adverse events, it was concluded that various characteristics of concomitant medications and patient's medical history should be evaluated properly before topical dermatological formulations of diclofenac are prescribed.