Montastruc François, Moulis Florence, Araujo Mélanie, Chebane Leila, Rascol Olivier, Montastruc Jean-Louis
Laboratoire de Pharmacologie Médicale et Clinique de la Faculté de Médecine et du Centre Hospitalier Universitaire de Toulouse, Toulouse, France.
Centre Midi-Pyrénées de PharmacoVigilance, de Pharmacoépidémiologie et d'Informations sur le Médicament, Pharmacopôle Midi-Pyrénées, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.
Eur J Clin Pharmacol. 2017 Jan;73(1):99-103. doi: 10.1007/s00228-016-2142-x. Epub 2016 Oct 27.
Some studies have suggested a potential risk of heart failure in patients with Parkinson's disease receiving dopamine (DA) agonists. However, the results are conflicting. We used VigiBase®, the World Health Organization (WHO) Global Individual Case Safety Reports (ICSRs) database, to investigate a potential signal strengthening of heart failure with DA agonists in Parkinsonian patients older than 45 years.
A case/non-case (disproportionality) analysis was performed in Vigibase® using ICSRs registered between 1978 and May 2016. The signal of disproportionality was calculated using reporting odds ratios (ROR). In our study, 154 ICSRs of heart failure occurring in 154 Parkinsonian patients (mean age 69.6 years, 51 % women) treated with DA agonists were included.
There was a significant signal between occurrence of heart failure and exposure to pergolide or cabergoline in particular and ergot derivatives in general. In contrast, none signal was found for rotigotine, pramipexole, apomorphine, or ropinirole in particular and non-ergot derivatives in general. The present study underlines the importance to prescribe as DA agonists in Parkinsonian patients only non-ergot derivatives, excluding ergot drugs.
一些研究表明,接受多巴胺(DA)激动剂治疗的帕金森病患者存在心力衰竭的潜在风险。然而,结果相互矛盾。我们使用世界卫生组织(WHO)全球个体病例安全报告(ICSRs)数据库VigiBase®,调查45岁以上帕金森病患者使用DA激动剂后心力衰竭潜在信号增强的情况。
在VigiBase®中对1978年至2016年5月期间登记的ICSRs进行病例/非病例(不成比例)分析。使用报告比值比(ROR)计算不成比例信号。在我们的研究中,纳入了154例接受DA激动剂治疗的帕金森病患者(平均年龄69.6岁,51%为女性)发生心力衰竭的154份ICSRs。
心力衰竭的发生与特别是培高利特或卡麦角林以及一般麦角衍生物的暴露之间存在显著信号。相比之下,未发现特别是罗替戈汀、普拉克索、阿扑吗啡或罗匹尼罗以及一般非麦角衍生物存在信号。本研究强调了在帕金森病患者中仅开具非麦角衍生物(不包括麦角药物)作为DA激动剂的重要性。