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使用美国食品药品监督管理局不良事件报告系统分析年龄与达托霉素所致不良事件发生之间的关联

Association between age and onset of daptomycin-induced adverse events using the U.S. food and drug administration adverse event reporting system.

作者信息

Shiraishi Chihiro, Kato Hideo, Ogura Toru, Iwamoto Takuya

机构信息

Department of Pharmacy, Mie University Hospital, Mie, Japan; Department of Clinical Pharmaceutics, Division of Clinical Medical Science, Mie University Graduate School of Medicine, Mie, Japan.

Department of Pharmacy, Mie University Hospital, Mie, Japan; Department of Clinical Pharmaceutics, Division of Clinical Medical Science, Mie University Graduate School of Medicine, Mie, Japan.

出版信息

J Infect Chemother. 2025 Jan;31(1):102501. doi: 10.1016/j.jiac.2024.08.016. Epub 2024 Aug 27.

Abstract

BACKGROUND

Daptomycin is a lipopeptide antibiotic with a broad spectrum of activity against gram-positive bacteria. Although information on daptomycin-induced adverse events can be found in clinical trials, data regarding the impact of age on these events are insufficient. Therefore, we evaluated whether age affects the occurrence of daptomycin-induced adverse events using adverse drug event reports in post-marketing stages provided by the U.S. Food and Drug Administration (FDA).

METHODS

A total dataset of 7307 reports of patients treated with daptomycin in the FDA's Adverse Event Reporting System were analyzed. The patients were divided into seven age groups: 0-28 days, >28 days-23 months, 2-11 years, 12-17 years, 18-64 years, 65-80 years, and >80 years. A disproportionality analysis was conducted to calculate the reporting odds ratio, with a 95 % confidence interval. The univariate regression analysis was conducted using the percentage of each adverse event and age groups.

RESULTS

Compared with the number of reports aged 18-64 years, there were significantly increased reports of eosinophilic pneumonia in patients aged 65-80 years and >80 years, anaphylactic reaction and pseudomembranous colitis in patients aged 12-17 years, and acute renal failure in patients aged 65-80 years. The regression coefficient for the reporting proportion of eosinophilic pneumonia was significantly positive.

CONCLUSIONS

Our findings revealed age-related trends in daptomycin-induced adverse events, supporting the idea that implementing age-dependent follow-up and supportive care helps in the continuation of daptomycin therapy.

摘要

背景

达托霉素是一种脂肽类抗生素,对革兰氏阳性菌具有广谱活性。虽然在临床试验中可以找到有关达托霉素引起的不良事件的信息,但关于年龄对这些事件影响的数据并不充分。因此,我们利用美国食品药品监督管理局(FDA)提供的上市后阶段药物不良事件报告,评估年龄是否会影响达托霉素引起的不良事件的发生。

方法

对FDA不良事件报告系统中7307例接受达托霉素治疗患者的报告数据集进行分析。患者分为7个年龄组:0 - 28天、>28天 - 23个月、2 - 11岁、12 - 17岁、18 - 64岁、65 - 80岁和>80岁。进行不成比例分析以计算报告比值比,并给出95%置信区间。使用各不良事件和年龄组的百分比进行单变量回归分析。

结果

与18 - 64岁年龄组的报告数量相比,65 - 80岁和>80岁患者的嗜酸性粒细胞性肺炎报告显著增加,12 - 17岁患者的过敏反应和假膜性结肠炎报告显著增加,65 - 80岁患者的急性肾衰竭报告显著增加。嗜酸性粒细胞性肺炎报告比例的回归系数显著为正。

结论

我们的研究结果揭示了达托霉素引起的不良事件与年龄相关的趋势,支持了实施基于年龄的随访和支持性护理有助于继续使用达托霉素治疗的观点。

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