Use and misuse of domperidone in patients living with Parkinson disease in France

IF 2.1 4区医学 Q3 PHARMACOLOGY & PHARMACY

Fundamental & Clinical Pharmacology Pub Date : 2025-03-10 DOI:10.1111/fcp.70002

Edouard Januel, Jean Christophe Corvol, Philippe Remy, Wassilios G. Meissner, Claire Thiriez, Aymeric Lanore, Cecilia Bonnet, Jean-Philippe Azulay, Caroline Giordana, David Maltete, Solene Frismand, Christine Tranchant, Francois Sellal, Alain Jager, Matthieu Béreau, Giovanni Castelnovo, Anne Evelyne Vallet, Maryse Lapeyre-Mestre, Jean-Denis Turc, Olivier Rascol, Florence Tubach, DUMP study group

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Abstract

Context

After observing increased sudden death risk associated with domperidone use, the European Medicines Agency (EMA) imposed usage restrictions in 2014, limiting age (≤60 years), daily dose (≤30 mg/day), and duration (≤7 days). Nausea commonly occurs as an adverse effect of dopaminergic drugs in Parkinson's disease (PD) patients, with few alternative anti-emetic options. This study aimed to assess domperidone prescription patterns in French PD patients.

Methods

In this multicenter study, all consecutive PD patients from participating expert centers, hospitals, and private neurologists were included. We documented demographics, clinical data, comorbidities, domperidone use (indication, dose, and duration), and concurrent medications (related to PD or not). Domperidone misuse was assessed based on EMA guidelines.

Results

Between January and October 2021, 1579 patients from 16 centers (12 French PD expert centers, two general hospitals, and two private practice neurologists) were included. Among them, 109 (7%) received domperidone: 32 (29%) for nausea during apomorphine infusion, 71 (65%) for nausea during other dopaminergic therapies, and three (3%) for orthostatic hypotension. Domperidone misuse was found in 103 patients (95%): treatment duration >7 days (84%), age >60 years (79%), contraindicated drug interactions (6%), and contraindications due to cardiac comorbidity (5%). Only one patient exceeded the recommended dose (30 mg/day).

Conclusion

Domperidone is still prescribed in France for PD patients with dopaminergic-induced nausea, mostly disregarding EMA guidelines due to patient age (>60 years) and prolonged treatment (>7 days). Our study underscores the unmet need for managing gastrointestinal symptoms in PD, highlighting the inadequacy of EMA guidelines in this population.

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多潘立酮在法国帕金森病患者中的使用和误用

在观察到与多潘立酮使用相关的猝死风险增加后，欧洲药品管理局（EMA）于2014年实施了使用限制，限制了年龄（≤60岁）、日剂量（≤30mg /天）和持续时间（≤7天）。在帕金森病（PD）患者中，恶心通常是多巴胺能药物的不良反应，很少有其他的止吐选择。本研究旨在评估法国PD患者的多潘立酮处方模式。方法在这项多中心研究中，包括所有来自专家中心、医院和私人神经科医生的连续PD患者。我们记录了人口统计学、临床数据、合并症、多潘立酮的使用（适应症、剂量和持续时间）以及同时使用的药物（与PD是否相关）。根据EMA指南评估了多潘立酮的滥用情况。结果2021年1月至10月，共纳入来自16个中心（12个法国PD专家中心、2个综合医院和2个私人执业神经科医生）的1579例患者。其中109例（7%）接受了多潘立酮治疗：32例（29%）因阿波吗啡输注期间恶心，71例（65%）因其他多巴胺能治疗期间恶心，3例（3%）因直立性低血压。103例（95%）患者发现多潘立酮滥用：治疗持续时间7天（84%），年龄60岁（79%），药物相互作用禁忌症（6%），心脏合并症禁忌症（5%）。只有一名患者超过了推荐剂量（30mg /天）。结论在法国，由于患者年龄（60岁）和治疗时间较长（7天），多潘立酮仍被用于PD患者多巴胺能引起的恶心，大多无视EMA指南。我们的研究强调了PD患者胃肠症状管理的未满足需求，强调了EMA指南在这一人群中的不足。

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来源期刊

Fundamental & Clinical Pharmacology 医学-药学

CiteScore

5.30

自引率

6.90%

发文量

111

审稿时长

6-12 weeks

期刊介绍： Fundamental & Clinical Pharmacology publishes reports describing important and novel developments in fundamental as well as clinical research relevant to drug therapy. Original articles, short communications and reviews are published on all aspects of experimental and clinical pharmacology including: Antimicrobial, Antiviral Agents Autonomic Pharmacology Cardiovascular Pharmacology Cellular Pharmacology Clinical Trials Endocrinopharmacology Gene Therapy Inflammation, Immunopharmacology Lipids, Atherosclerosis Liver and G-I Tract Pharmacology Metabolism, Pharmacokinetics Neuropharmacology Neuropsychopharmacology Oncopharmacology Pediatric Pharmacology Development Pharmacoeconomics Pharmacoepidemiology Pharmacogenetics, Pharmacogenomics Pharmacovigilance Pulmonary Pharmacology Receptors, Signal Transduction Renal Pharmacology Thrombosis and Hemostasis Toxicopharmacology Clinical research, including clinical studies and clinical trials, may cover disciplines such as pharmacokinetics, pharmacodynamics, pharmacovigilance, pharmacoepidemiology, pharmacogenomics and pharmacoeconomics. Basic research articles from fields such as physiology and molecular biology which contribute to an understanding of drug therapy are also welcomed.