目标:达里多雷生,一种新型的双食欲素受体拮抗剂,2022年被FDA批准用于治疗成人失眠。本研究的目的是通过分析FAERS数据库中的数据,深入研究daridorexant的不良事件(AE)。评估其在临床应用中的安全性和有效性。
方法:本研究从FAERS数据库中选择了2022年第一季度至2023年第三季度的数据。使用了各种数据分析方法,包括报告赔率比(ROR),比例报告比率(PRR),贝叶斯置信传播神经网络(BCPNN),和经验贝叶斯几何均值(EBGM),评估与daridorexant相关的不良事件。
结果:该研究共分析了2,624,030例不良事件报告,其中1318人与daridorexant有关。它确定了59个首选术语(PT),涉及23个系统器官类别(SOC)。信号挖掘发现了与daridorexant相关的新的潜在AE,包括与睡眠有关的精神症状(噩梦,不正常的梦,睡眠恐怖,等。),情绪和知觉异常(幻觉,抑郁症,搅动),生理和行为反应(心悸,口干,能量增加,等。),自杀风险(自杀意念,故意过量),和其他特别关注的AE(快速性,与睡眠有关的进食障碍,超敏反应)。
结论:尽管已经发现了一些新的潜在不良事件,由于数据源和分析方法的局限性,这些发现需要在更广泛的数据集和长期研究中进一步验证.未来的研究应该全面评估达立多生的安全性和有效性,为医疗专业人员治疗失眠提供更准确的指导。
OBJECTIVE: Daridorexant, a novel dual orexin receptor antagonist, was approved by the FDA in 2022 for the treatment of insomnia in adults. The aim of this study is to delve into the adverse events (AEs) of daridorexant by analyzing data from the FAERS database, to assess its safety and effectiveness in clinical applications.
METHODS: This study selected data from the FAERS database from the first quarter of 2022 to the third quarter of 2023. Various data analysis methods were used, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM), to assess AEs related to daridorexant.
RESULTS: The study analyzed a total of 2,624,030 AE reports, of which 1318 were related to daridorexant. It identified 59 preferred terms (PTs) involving 23 system organ classes (SOCs). Signal mining identified new potential AEs related to daridorexant, including sleep-related psychiatric symptoms (nightmare, abnormal dreams, sleep terror, etc.), emotional and perceptual abnormalities (hallucination, depression, agitation), physiological and behavioral responses (palpitations, dry mouth, energy increased, etc.), suicide risk (suicidal ideation, intentional overdose), and other special concern AEs (tachyphrenia, sleep-related eating disorder, hypersensitivity).
CONCLUSIONS: Although some new potential AEs have been identified, these findings need further verification in broader datasets and long-term studies due to limitations in data sources and analysis methods. Future research should comprehensively assess the safety and effectiveness of daridorexant, providing more accurate guidance for medical professionals in the treatment of insomnia.