Levodopa Equivalent Dose of Safinamide: A Multicenter, Longitudinal, Case–Control Study
Roberto Cilia, Emanuele Cereda, Marco Piatti, Andrea Pilotto, Luca Magistrelli, Nico Golfrè Andreasi, Salvatore Bonvegna, Elena Contaldi, Francesca Mancini, Gabriele Imbalzano, Rosa De Micco, Fabiana Colucci, Arianna Braccia, Gabriele Bellini, Francesco Brovelli, Roberta Zangaglia, Giulia Lazzeri, Maria Claudia Russillo, Enrica Olivola, Chiara Sorbera, Viviana Cereda, Patrizia Pinto, Patrizia Sucapane, Giorgio Gelosa, Mario Meloni, Francesca Pistoia, Maria Sessa, Margherita Canesi, Nicola Modugno, Claudio Pacchetti, Laura Brighina, Maria Teresa Pellecchia, Roberto Ceravolo, Mariachiara Sensi, Maurizio Zibetti, Cristoforo Comi, Alessandro Padovani, Anna Zecchinelli, Alessio Di Fonzo, Alessandro Tessitore, Francesca Morgante, Roberto Eleopra
Abstract
Abstract Background 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. Objectives To estimate LED of safinamide 50 and 100 mg. Methods 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 ( N = 130), safinamide 50 mg ( N = 144), or rasagiline 1 mg ( N = 97) for 9 ± 3 months and a control group of patients never treated with any iMAO‐B ( N = 129). Results 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. Conclusions We used a rigorous approach to calculate LED of safinamide 50 and 100 mg. Large prospective pragmatic trials are needed to replicate our findings.