장기작용 및 속효성 벤조디아제핀 사용 후 자발적 부작용 보고양상 비교

Abstract

To assess the patterns of adverse event reports including long-acting benzodiazepines compared with short-acting. Methods: Among the individual case safety reports (ICSRs) reported to KIDS-KAERS database (KIDS-KD) between 2016 and 2020, reports for benzodiazepines were selected. Benzodiazepines were categorized into two groups (long-acting and short-acting) based on their elimination half-life of 24 hours. We compared distribution of reported adverse events following long-acting compared by short-acting benzodiazepines. For comparing patterns of reported adverse events, we adopted the criteria of signal detection: proportional reporting ratio (PRR, PRR ≥ 2, cases ≥ 3, χ2 ≥ 4), reporting odds ratio (ROR, ROR ≥ 2, cases ≥ 3, χ2 ≥ 4), and log of information component (IC, IC_low > 0). Results: Among the total of 3,047,435 ICSRs in the KIDS-KD, the number of ICSRs for long-acting benzodiazepines users was 9,490 (0.3%) and short acting benzodiazepines users was 21,179 (0.7%). The average age was 59 years old. The number of patients aged over 65 years old for long-acting and short-acting benzodiazepines was 3,687 (38.9%) and 7,953 (37.6%), respectively. Adverse events such as delusion (PRR, 2.8), gait abnormal (PRR, 2.6), hypotonia (PRR, 2.6), migraine (PRR, 5.6), or else were reported significantly higher in long-acting benzodiazepines. Conclusion: We confirmed that adverse events including gait abnormal and delusion showed higher reporting ratios in long-acting benzodiazepines compared with short-acting benzodiazepines. Therefore, caution is required when using long acting benzodiazepines.