Cilia Roberto, Cereda Emanuele, Piatti Marco, Pilotto Andrea, Magistrelli Luca, Golfrè Andreasi Nico, Bonvegna Salvatore, Contaldi Elena, Mancini Francesca, Imbalzano Gabriele, De Micco Rosa, Colucci Fabiana, Braccia Arianna, Bellini Gabriele, Brovelli Francesco, Zangaglia Roberta, Lazzeri Giulia, Russillo Maria Claudia, Olivola Enrica, Sorbera Chiara, Cereda Viviana, Pinto Patrizia, Sucapane Patrizia, Gelosa Giorgio, Meloni Mario, Pistoia Francesca, Sessa Maria, Canesi Margherita, Modugno Nicola, Pacchetti Claudio, Brighina Laura, Pellecchia Maria Teresa, Ceravolo Roberto, Sensi Mariachiara, Zibetti Maurizio, Comi Cristoforo, Padovani Alessandro, Zecchinelli Anna L, Di Fonzo Alessio, Tessitore Alessandro, Morgante Francesca, Eleopra Roberto
Department of Clinical Neurosciences, Parkinson and Movement Disorders Unit Fondazione IRCCS Istituto Neurologico Carlo Besta Milan Italy.
Clinical Nutrition and Dietetics Unit Fondazione IRCCS Policlinico San Matteo Pavia Italy.
Mov Disord Clin Pract. 2023 Feb 15;10(4):625-635. doi: 10.1002/mdc3.13681. eCollection 2023 Apr.
Effects of dopaminergic medications used to treat Parkinson's disease (PD) may be compared with each other by using conversion factors, calculated as Levodopa equivalent dose (LED). However, current LED proposals on MAO-B inhibitors (iMAO-B) safinamide and rasagiline are still based on empirical approaches.
To estimate LED of safinamide 50 and 100 mg.
In this multicenter, longitudinal, case-control study, we retrospectively reviewed clinical charts of 500 consecutive PD patients with motor complications and treated with (i) safinamide 100 mg ( = 130), safinamide 50 mg ( = 144), or rasagiline 1 mg ( = 97) for 9 ± 3 months and a control group of patients never treated with any iMAO-B ( = 129).
Major baseline features (age, sex, disease duration and stage, severity of motor signs and motor complications) were similar among the groups. Patients on rasagiline had lower UPDRS-II scores and Levodopa dose than control subjects. After a mean follow-up of 8.8-to-10.1 months, patients on Safinamide 50 mg and 100 mg had lower UPDRS-III and OFF-related UPDRS-IV scores than control subjects, who in turn had larger increase in total LED than the three iMAO-B groups. After adjusting for age, disease duration, duration of follow-up, baseline values and taking change in UPDRS-III scores into account (sensitivity analysis), safinamide 100 mg corresponded to 125 mg LED, whereas safinamide 50 mg and rasagiline 1 mg equally corresponded to 100 mg LED.
We used a rigorous approach to calculate LED of safinamide 50 and 100 mg. Large prospective pragmatic trials are needed to replicate our findings.
用于治疗帕金森病（PD）的多巴胺能药物的效果可以通过使用转换因子进行相互比较，该转换因子以左旋多巴等效剂量（LED）计算。然而，目前关于单胺氧化酶B抑制剂（iMAO - B）沙芬酰胺和雷沙吉兰的LED建议仍基于经验方法。
估算50毫克和100毫克沙芬酰胺的LED。
在这项多中心、纵向、病例对照研究中，我们回顾性分析了500例有运动并发症且接受以下治疗的连续性PD患者的临床病历：（i）100毫克沙芬酰胺（n = 130）、50毫克沙芬酰胺（n = 144）或1毫克雷沙吉兰（n = 97），治疗9±3个月，以及一个从未接受过任何iMAO - B治疗的对照组患者（n = 129）。
各组间主要基线特征（年龄、性别、病程和分期、运动体征和运动并发症的严重程度）相似。服用雷沙吉兰的患者的统一帕金森病评定量表第二部分（UPDRS - II）评分和左旋多巴剂量低于对照组。在平均随访8.8至10.1个月后，服用50毫克和100毫克沙芬酰胺的患者的统一帕金森病评定量表第三部分（UPDRS - III）评分和与“关”期相关的统一帕金森病评定量表第四部分（UPDRS - IV）评分低于对照组，而对照组的总LED增加量大于三个iMAO - B组。在对年龄、病程、随访时间、基线值进行校正并考虑UPDRS - III评分变化后（敏感性分析），100毫克沙芬酰胺相当于125毫克LED，而50毫克沙芬酰胺和1毫克雷沙吉兰均相当于100毫克LED。
我们采用了严谨的方法来计算50毫克和100毫克沙芬酰胺的LED。需要进行大型前瞻性实用试验来重复我们的研究结果。
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