Session Information
Date: Monday, September 23, 2019
Session Title: Clinical Trials, Pharmacology and Treatment
Session Time: 1:45pm-3:15pm
Location: Agora 3 West, Level 3
Objective: We present a prospective observational-real life study about the use of safinamide in Movement Disorders Unit´s patients.
Background: The gold standard of pharmacological treatment in Parkinson disease (PD) is L-Dopa (LD) but the progression of disease leads to the development of fluctuations. Safinamida is a novel MAO B-I used for motor and non motor fluctuations in PD
Method: We evaluate safinamide´s effects in 47 patients (43.5% women, mean age 67.57 years SD 12.2), in combinated therapy with dopamine agonists 78.3%, LD+benserazide 17.4%, LD+carbidopa 30.4%, LD+entacapone 47.8%, advanced therapies 4.3%. 46.8% patients had treated with rasagiline previously. Basal UPDRS-III 25.19. They presented motor complications: morning-akinesia 59.1%, wearing-OFF 70.5%, unpredictable-OFF 16.3% and dyskinesias 65.9%. Change was evaluated in MDS UPDRS-III, presence/severity of fluctuations-dyskinesias through diaries, Global Clinical Scale-CGI and SNM at 6 months.
Results: 45 patients completed the study at 6 months (1 dropped out due to inefficiency and 1 due to adverse effects), observing a statistically significant decrease in morning akinesia 43.2%, wearing-OFF 43.2% and MDS UPDRS-III scores. Unpredictable-OFF doesn´t vary significantly. Dyskinesias doesn´t vary significantly. In the group of 22 patients who switch rasagiline to safinamide, morning akinesia, wearing-OFF and MDS UPDRS-III improve statistically significant. Depression decrease, there are no changes significant in other Non-Motor-Symptoms (apathy, cognitive deterioration, hallucinations, ICD). About 71.1% of patients report finding themselves better, 22.2% similar and 6.7% worse with the addition of safinamide.
Conclusion: Safinamide is safe in terms of adverse effects, especially improving motor fluctuations, motor-symptoms and subjective perception of PD severity, even in patients who switch rasagiline to safinamide.
To cite this abstract in AMA style:
N. López-Ariztegui, MI. Morales-Casado, JC. Segundo-Rodríguez, A. Avila-Fernández, N. García-Alvarado, J. Pérez-Matos. Safinamide: real world evidence in Toledo´s Movement Disorders Unit [abstract]. Mov Disord. 2019; 34 (suppl 2). https://www.mdsabstracts.org/abstract/safinamide-real-world-evidence-in-toledos-movement-disorders-unit/. Accessed May 16, 2025.« Back to 2019 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/safinamide-real-world-evidence-in-toledos-movement-disorders-unit/