Analyses of non-benzodiazepine-induced adverse events and prognosis in elderly patients based on the Japanese adverse drug event report database

Yoshihiro Noguchi; Anri Ueno; Hayato Katsuno; Manami Otsubo; Aki Yoshida; Yuta Kanematsu; Ikuto Sugita; Tomoya Tachi; Teruo Tsuchiya; Hitomi Teramachi

doi:10.1186/s40780-018-0106-2

Analyses of non-benzodiazepine-induced adverse events and prognosis in elderly patients based on the Japanese adverse drug event report database

J Pharm Health Care Sci. 2018 May 7:4:10. doi: 10.1186/s40780-018-0106-2. eCollection 2018.

Authors

Yoshihiro Noguchi¹, Anri Ueno¹, Hayato Katsuno¹, Manami Otsubo¹, Aki Yoshida¹, Yuta Kanematsu¹, Ikuto Sugita¹, Tomoya Tachi¹, Teruo Tsuchiya^{1

2}, Hitomi Teramachi^{1

3}

Affiliations

¹ 1Laboratory of Clinical Pharmacy, Gifu Pharmaceutical University, 1-25-4, Daigakunishi, Gifu, 501-1196 Japan.
² Community Health Support and Research Center, 5-6-1, kikuchichou, Gifu, 501-6242 Japan.
³ 3Laboratory of Community Healthcare Pharmacy, Gifu Pharmaceutical University, 1-25-4, Daigakunishi, Gifu, 501-1196 Japan.

Abstract

Background: The contents of the guidelines for the use of non-benzodiazepines (Z-drugs) differ slightly between THE JAPANESE SOCIETY OF SLEEP RESEARCH and THE JAPAN GERIATRIC SOCIETY, and the recommended directions are conflicting. Therefore, we analyzed the use of the Japanese Adverse Drug Event Report database (JADER) for identifying adverse events (AEs) caused by Z-drugs and clarifying their occurrence trend and prognosis.

Methods: The signal value for comparison was calculated by using the proportional reporting ratio (PRR) and chi-squared test (χ²) results of data of elderly and non-elderly patients. Among AEs for which signals were detected in the elderly, we determined that those with lower signal values for non-elderly patients that were half the signal value of the elderly should be used with particular caution in the elderly. We also compared the prognoses.

Results: The AEs with > 1 risk ratio (RR) in elderly and non-elderly patients were regarded as those that should be noted in the prognosis of AEs in elderly patients. Furthermore, 28 AEs were detected in elderly patients' signals. In this study, in addition to movement disorders such as "falls" and "bone fractures," identified by two academic societies, signal characteristics of the elderly were obtained for psychiatric disorders and eye disorders.

Conclusions: There was no difference in prognosis, but these disorders could reduce the quality of life of patients. Therefore, we consider that in prescribing appropriate drug therapy for insomnia, attention should be paid to the occurrence of the AEs caused by the Z-drugs revealed by this study and the guidelines.

Keywords: Elderly patients; Japanese adverse drug event report database (JADER); Non-benzodiazepine (Z-drug); Signal detection.