Objective: Describe the clinical experience with Safinamide and assess the patients’ adherence to this treatment in the movement disorders centre of Trieste-Italy.

Background: Safinamide (Xadago®) is the latest monoamine oxidase -B inhibitor (I-MAOB) approved in EU for the treatment of Parkinson’s disease (PD). It is recommended for PD patients with motor fluctuations, as add-on therapy. Evidences coming from both randomized-controlled trials and real life observational studies, showed that Safinamide is generally safe and well tolerated.

Method: All PD patients referred to the Movement Disorders Unit of the Neurology Department of Trieste, Italy (about 600) has been evaluated. Upon them, patients who had received Safinamide at any time between January 2016 and October 2021, have been enrolled. For each patient, the following clinical data were collected: sex, age, disease duration, concomitant PD therapies, dose of the drug (50 mg or 100 mg), treatment duration, treatment discontinuation and reason for discontinuation (side effects, lack of efficacy, disease progression or death). Patients with incomplete data or with disconfirmation of the diagnosis of PD during the follow up period, were excluded from the analysis.

Results: Safinamide was recommended in a total of 93 patients during the time of observation. 47 patients (50.5%) were still in treatment with Safinamide at the end of the observation (24 with 100 mg and 25 with 50 mg); upon these 13 patients has been taking the drug for more than 4 years. In 46 patients the drug was discontinued, in 25 subjects this occurred during the first year of treatment.  The reason for discontinuation were: side effects (22 patients), disease progression (10), lack of efficacy (8) and death (6). Dyskinesias and hallucinations were the main causes of drug discontinuation. Patients who were still taking Safinamide at the end of observation have significantly shorter mean disease duration compared to patients who discontinued the drug (7.8 vs 12.1 p=0.02). 32 patients switched to Safinamide from a different I-MAOB, upon this group of patients, the adherence reached 60%.

Conclusion: Our real-life study confirmed that Safinamide is generally well tolerated in more than a half of patients. For those that dropped out the treatment, the main reasons were side effects and lack of efficacy. Safinamide is likely to be more tolerated in earlier stage of the disease.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/safinamide-adherence-the-experience-of-the-movement-disorder-unit-of-trieste/