Objective: Evaluating the efficacy and security starting safinamide treatment with 100 mg/day in PD

Background: Safinamide has a unique dopaminergic and non-dopaminergic mode of action that includes the enhancement of the dopaminergic transmission through the selective and reversible inhibition of the monoamine-oxidase B enzyme, and the control of the abnormal glutamate release through the state- and use-dependent blockade of the sodium channels which can be appreciated at dose of 100 mg. Safinamide has therefore the potential to improve both motor and non-motor symptoms and complications when used at 100 mg daily dose since the beginning, such as in the 016 and 018 studies.

Method: Among the population diagnosed with PD in our ambulatory, we identified 80 patients that needed therapeutic adjustment because of worsening of symptoms or complications related to the disease that could benefit from both dopaminergic and glutamatergic mechanisms, being started directly with safinamide 100 mg. We reviewed retrospectively the efficacy and safety of this new therapeutic approach.

Results: The evaluation of our clinical routine showed good efficacy and safety profile, among the 80 patients identified that have started directly with safinamide 100 mg daily. We found out that 100% (n=80) continued with the treatment showing a very good safety profile. Among them 73,75% (n=59) showed clinical improvements in non-motor symptoms (mainly in sleep disorders and pain) and motor symptoms and complications (ON time and dyskinesias); 18.75% (n=15) maintained their symptoms and/or complications stable, and only 7,5% (n=6) needed a new medication adjustment (adding opicapone, without any safety issue).

Conclusion: Safinamide improved motor and non-motor symptoms and complications without increasing troublesome dyskinesia, maintaining the benefits in the long-term with a significant improvement of patients’ quality of life. These favorable effects may be explained by its modulation of both dopaminergic action and glutamatergic hyperactivity regulation.
Therefore, in our clinical experience starting with a dose of safinamide 100 mg daily is effective and safe, and may offer more benefits than increasing gradually from safinamide 50 mg daily as the patient could benefit from both safinamide actions, dopaminergic and glutamatergic, since the beginning of the treatment.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/efficacy-and-security-starting-safinamide-treatment-with-100-mg-day-in-parkinsons-disease/