Department of Neurology, Medical School, University of Pécs, Pécs, Hungary 7623
Department of Neurology, Medical School, Semmelweis University, Budapest, Hungary 1085.
eNeuro. 2021 May 19;8(3). doi: 10.1523/ENEURO.0452-20.2021. Print 2021 May-Jun.
Trimetazidine (TMZ), an antianginal drug, can worsen the symptoms of movement disorders, therefore, the European Medicines Agency (EMA) recommended avoiding the use of this drug in Parkinson's disease (PD). We investigated the impact of this recommendation on the observed trend of TMZ use in PD in Hungary from 2010 to 2016 by conducting a nationwide, retrospective study of health administrative data of human subjects. Interrupted time series analyses were performed to explore changes in user trends after the EMA recommendations. We found that TMZ use in PD decreased by 6.56% in each six-month interval after the EMA intervention [a change in trend of -530.22, 95% confidence interval (CI) = -645.00 to -415.44, < 0.001 and a decrease in level of -567.26, 95% CI = -910.99 to -223.53, = 0.005 12 months postintervention]. TMZ discontinuation was the highest immediately after the intervention, however, its rate slowed down subsequently (a change in trend of -49.69, 95% CI = -85.14 to -14.24, = 0.11 without significant level effects). The rate of new TMZ prescriptions did not reduce significantly, therefore, the decreased overall use was mainly attributable to the increased rate of discontinuation only. The main indications for TMZ use were circulatory system disorders, especially angina pectoris, however, off-label utilization was also considerable (40%). The EMA recommendations on TMZ use seem to be only moderately effective in Hungary. Although the number of patients with PD on the drug modestly decreased after the EMA restrictions, TMZ is still widely used in PD for both on-label and off-label indications.
曲美他嗪（TMZ）是一种抗心绞痛药物，可能会加重运动障碍的症状，因此，欧洲药品管理局（EMA）建议避免将该药物用于帕金森病（PD）。我们通过对匈牙利 2010 年至 2016 年人类健康管理数据进行全国性回顾性研究，调查了这一建议对 PD 中 TMZ 使用观察趋势的影响。我们采用中断时间序列分析来探讨 EMA 建议后用户趋势的变化。我们发现，在 EMA 干预后的每 6 个月间隔内，PD 中 TMZ 的使用减少了 6.56%[趋势变化为-530.22，95%置信区间（CI）=-645.00 至-415.44， < 0.001，水平变化为-567.26，95%CI=-910.99 至-223.53， = 0.005 12 个月后干预]。TMZ 停药率在干预后立即达到最高，但随后逐渐放缓（趋势变化-49.69，95%CI=-85.14 至-14.24， = 0.11，无显著水平效应）。新 TMZ 处方的开具率没有明显降低，因此，整体使用量的减少主要归因于停药率的增加。TMZ 的主要适应证是循环系统疾病，尤其是心绞痛，但也有相当数量的适应证为超适应证（40%）。EMA 关于 TMZ 使用的建议在匈牙利的效果似乎只是中等。尽管 EMA 限制后接受 TMZ 治疗的 PD 患者数量略有减少，但 TMZ 仍广泛用于 PD 的适应证，包括适应证内和适应证外的使用。
