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Levodopa Equivalent Dose of Safinamide: A Multicenter, Longitudinal, Case-Control Study

Cilia, R; Cereda, E; Piatti, M; Pilotto, A; Magistrelli, L; Andreasi, NG; Bonvegna, S; Contaldi, E; Mancini, F; Imbalzano, G; et al. Cilia, R; Cereda, E; Piatti, M; Pilotto, A; Magistrelli, L; Andreasi, NG; Bonvegna, S; Contaldi, E; Mancini, F; Imbalzano, G; De Micco, R; Colucci, F; Braccia, A; Bellini, G; Brovelli, F; Zangaglia, R; Lazzeri, G; Russillo, MC; Olivola, E; Sorbera, C; Cereda, V; Pinto, P; Sucapane, P; Gelosa, G; Meloni, M; Pistoia, F; Sessa, M; Canesi, M; Modugno, N; Pacchetti, C; Brighina, L; Pellecchia, MT; Ceravolo, R; Sensi, M; Zibetti, M; Comi, C; Padovani, A; Zecchinelli, AL; Di Fonzo, A; Tessitore, A; Morgante, F; Eleopra, R (2023) Levodopa Equivalent Dose of Safinamide: A Multicenter, Longitudinal, Case-Control Study. MOVEMENT DISORDERS CLINICAL PRACTICE, 10 (4). pp. 625-635. ISSN 2330-1619 https://doi.org/10.1002/mdc3.13681
SGUL Authors: Morgante, Francesca

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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.

Item Type: Article
Additional Information: © 2023 The Authors. Movement Disorders Clinical Practice published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society. This is an open access article under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
Keywords: Parkinson's disease, levodopa equivalent dose, LED, safinamide, Rasagiline
SGUL Research Institute / Research Centre: Academic Structure > Molecular and Clinical Sciences Research Institute (MCS)
Journal or Publication Title: MOVEMENT DISORDERS CLINICAL PRACTICE
ISSN: 2330-1619
Dates:
DateEvent
14 April 2023Published
15 February 2023Published Online
21 January 2023Accepted
Publisher License: Creative Commons: Attribution 4.0
Web of Science ID: WOS:000930985500001
URI: https://openaccess.sgul.ac.uk/id/eprint/115266
Publisher's version: https://doi.org/10.1002/mdc3.13681

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