揭示药物诱发冲动的负担:美国食品和药物管理局不良事件报告系统网络分析》。

IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY
Drug Safety Pub Date : 2024-12-01 Epub Date: 2024-08-15 DOI:10.1007/s40264-024-01471-z
Michele Fusaroli, Stefano Polizzi, Luca Menestrina, Valentina Giunchi, Luca Pellegrini, Emanuel Raschi, Daniel Weintraub, Maurizio Recanatini, Gastone Castellani, Fabrizio De Ponti, Elisabetta Poluzzi
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引用次数: 0

摘要

导言:普拉克索(pramipexole)和阿立哌唑(aripiprazole)等多巴胺能药物诱发的冲动性可导致行为成瘾,影响患者和家庭的社会功能和生活质量(如导致失业、婚姻问题和焦虑)。这些次生效应在体征和症状网络中相互关联,通常被临床试验忽视,未在包装说明书中报告,在临床实践中也被忽视:本研究探讨了普拉克索和阿立哌唑诱发冲动的综合症负担,找出关键症状,以便有针对性地缓解冲动:美国食品和药物管理局不良事件报告系统(FAERS)的事件-事件信息组件(IC)(2004年1月至2022年3月)分别确定了普拉克索和阿立哌唑与冲动不成比例地共同报告的事件综合征。通过对复合网络分析(正向点互信息[PPMI]、Ising、Φ)进行贪婪模块化聚类,确定了亚综合征。贝叶斯网络模型突出了可能的诱发事件:7.49%的普拉克索受试者和4.50%的阿立哌唑受试者有疑似药物诱发冲动的记录。普拉克索的最高IC涉及强迫症(报告率=26.77%;IC中位数=3.47,95%置信区间[CI]=3.33-3.57)和情绪困扰(21.35%;3.42,3.26-3.54),阿立哌唑的最高IC涉及破产(10.58%;4.43,4.26-4.55)和离婚(7.59%;4.38,4.19-4.53)。网络分析确定了普拉克索的妄想性嫉妒和多巴胺调节障碍亚综合征,阿立哌唑的肥胖-过度通气和社会问题。贝叶斯网络强调焦虑和经济问题是潜在的诱发事件:结论:药物诱发冲动的后果尚未得到充分探讨,这给患者和家庭造成了沉重负担。探索综合反应和潜在诱发事件的网络分析是对传统技术和临床判断的补充。确定反应的次要影响将有助于做出以患者为中心的明智决策。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Unveiling the Burden of Drug-Induced Impulsivity: A Network Analysis of the FDA Adverse Event Reporting System.

Unveiling the Burden of Drug-Induced Impulsivity: A Network Analysis of the FDA Adverse Event Reporting System.

Introduction: Impulsivity induced by dopaminergic agents, like pramipexole and aripiprazole, can lead to behavioral addictions that impact on social functioning and quality of life of patients and families (e.g., resulting in unemployment, marital problems, anxiety). These secondary effects, interconnected in networks of signs and symptoms, are usually overlooked by clinical trials, not reported in package inserts, and neglected in clinical practice.

Objective: This study explores the syndromic burden of impulsivity induced by pramipexole and aripiprazole, pinpointing key symptoms for targeted mitigation.

Methods: An event-event Information Component (IC) on the FDA Adverse Event Reporting System (FAERS) (January 2004 to March 2022) identified the syndrome of events disproportionally co-reported with impulsivity, separately for pramipexole and aripiprazole. A greedy-modularity clustering on composite network analyses (positive pointwise mutual information [PPMI], Ising, Φ) identified sub-syndromes. Bayesian network modeling highlighted possible precipitating events.

Results: Suspected drug-induced impulsivity was documented in 7.49% pramipexole and 4.50% aripiprazole recipients. The highest IC concerned obsessive-compulsive disorder (reporting rate = 26.77%; IC median = 3.47, 95% confidence interval [CI] = 3.33-3.57) and emotional distress (21.35%; 3.42, 3.26-3.54) for pramipexole, bankruptcy (10.58%; 4.43, 4.26-4.55) and divorce (7.59%; 4.38, 4.19-4.53) for aripiprazole. The network analysis identified delusional jealousy and dopamine dysregulation sub-syndromes for pramipexole, obesity-hypoventilation and social issues for aripiprazole. The Bayesian network highlighted anxiety and economic problems as potentially precipitating events.

Conclusion: The under-explored consequences of drug-induced impulsivity significantly burden patients and families. Network analyses, exploring syndromic reactions and potential precipitating events, complement traditional techniques and clinical judgment. Characterizing the secondary impact of reactions will support informed patient-centered decision making.

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来源期刊
Drug Safety
Drug Safety 医学-毒理学
CiteScore
7.60
自引率
7.10%
发文量
112
审稿时长
6-12 weeks
期刊介绍: Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.
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