Pharmacology Unit, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.
Unit of Medical Physics, Department of Medical and Surgical Sciences, University of Bologna, 40138, Bologna, Italy.
Drug Saf. 2024 Dec;47(12):1275-1292. doi: 10.1007/s40264-024-01471-z. Epub 2024 Aug 15.
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.
This study explores the syndromic burden of impulsivity induced by pramipexole and aripiprazole, pinpointing key symptoms for targeted mitigation.
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.
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.
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.
多巴胺能药物(如普拉克索和阿立哌唑)引起的冲动可导致行为成瘾,影响患者和家庭的社会功能和生活质量(例如导致失业、婚姻问题、焦虑)。这些次级效应通过症状和体征网络相互关联,但通常被临床试验忽视,药物说明书中没有报告,临床实践中也被忽视。
本研究探讨了普拉克索和阿立哌唑引起的冲动的综合征负担,确定了针对目标缓解的关键症状。
使用 FDA 不良事件报告系统(FAERS)的事件-事件信息成分(IC)(2004 年 1 月至 2022 年 3 月),分别针对普拉克索和阿立哌唑,确定与冲动不成比例地共同报告的事件综合征。对复合网络分析(正点互信息[PPMI]、Ising、Φ)的贪婪模块聚类确定亚综合征。贝叶斯网络建模突出了可能的诱发事件。
在 7.49%的普拉克索和 4.50%的阿立哌唑使用者中记录了可疑的药物引起的冲动。最高的 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)用于普拉克索,破产(10.58%;4.43,4.26-4.55)和离婚(7.59%;4.38,4.19-4.53)用于阿立哌唑。网络分析确定了普拉克索的妄想嫉妒和多巴胺失调亚综合征,阿立哌唑的肥胖低通气和社会问题亚综合征。贝叶斯网络突出了焦虑和经济问题作为潜在的诱发事件。
药物引起的冲动的未充分探索的后果对患者和家庭造成了重大负担。网络分析探讨了综合征反应和潜在诱发事件,补充了传统技术和临床判断。描述反应的次要影响将支持以患者为中心的知情决策。