关键词: Parkinson's disease melatonin receptor agonists pharmacovigilance database reporting odds ratio

Mesh : Parkinson Disease / drug therapy Humans Indenes / therapeutic use Acetamides / therapeutic use Receptors, Melatonin / agonists Male Female Aged Tetrahydronaphthalenes / therapeutic use Middle Aged Benzofurans Cyclopropanes Naphthalenes

来  源:   DOI:10.1111/jpi.13002

Abstract:
Parkinson\'s disease affects millions of people worldwide, and without significant progress in disease prevention and treatment, its incidence and prevalence could increase by more than 30% by 2030. Researchers have focused on targeting sleep and the circadian system as a novel treatment strategy for Parkinson\'s disease. This study investigated the association between melatonin receptor agonists and Parkinson\'s disease, using the Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS). The target drugs were melatonin receptor agonists including ramelteon, tasimelteon, and agomelatine. Parkinson\'s disease cases were defined according to the Medical Dictionary for Regulatory Activities (MedDRA) 25.0; Standardized MedDRA Query (SMQ) using both the \"narrow\" and \"broad\" preferred terms (PTs) associated with Parkinson\'s disease. The association between melatonin receptor agonists (ramelteon, tasimelteon, and agomelatine) and Parkinson\'s disease was evaluated by the reporting odds ratio. Upon analyzing the data from all patients registered in the FAERS, ramelteon (ROR: 0.66, 95% confidence interval [95% CI]: 0.51-0.84) and tasimelteon (ROR: 0.49, 95% CI: 0.38-0.62) showed negative correlations with Parkinson\'s disease. Conversely, only agomelatine was positively correlated with Parkinson\'s disease (ROR: 2.63, 95% CI: 2.04-3.40). These results suggest that among the melatonin receptor agonists, ramelteon and tasimelteon are negatively correlated with Parkinson\'s disease. In contrast, agomelatine was shown to be positively correlated with Parkinson\'s disease. These results should be used in research to develop drugs for the treatment of Parkinson\'s disease, fully considering the limitations of the spontaneous reporting system.
摘要:
帕金森病影响着全世界数百万人,在疾病预防和治疗方面没有重大进展,到2030年,其发病率和患病率可能增加30%以上。研究人员专注于针对睡眠和昼夜节律系统作为帕金森病的一种新的治疗策略。这项研究调查了褪黑激素受体激动剂与帕金森病之间的关系。使用美国食品和药物管理局(FDA)不良事件报告系统(FAERS)。目标药物是褪黑激素受体激动剂,包括ramelteon,tasimelteon,和阿戈美拉汀.根据监管活动医学词典(MedDRA)25.0定义帕金森病病例;标准化MedDRA查询(SMQ),使用与帕金森病相关的“窄”和“宽”首选术语(PT)。褪黑激素受体激动剂(ramelteon,tasimelteon,和阿戈美拉汀)和帕金森病通过报告比值比进行评估。在分析了所有在FAERS登记的患者的数据后,ramelteon(ROR:0.66,95%置信区间[95%CI]:0.51-0.84)和tasimelteon(ROR:0.49,95%CI:0.38-0.62)与帕金森病呈负相关。相反,只有阿戈美拉汀与帕金森病呈正相关(ROR:2.63,95%CI:2.04-3.40)。这些结果表明,在褪黑激素受体激动剂中,ramelteon和他汀与帕金森病呈负相关。相比之下,阿戈美拉汀与帕金森病呈正相关。这些结果应用于研究开发治疗帕金森病的药物,充分考虑了自发报告制度的局限性。
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