Objective: Evaluating the maintenance of safinamide 100 mg daily as a long-term treatment.

Background: The effects of safinamide were investigated in studies 016, 018 and SETTLE (clinical trials). Both studies 016 and SETTLE were 6 month, double blind, placebo-controlled trials comparing safinamide versus placebo as adjunct therapy to levodopa where 89% and 88% patients, respectively, maintained the treatment during these 6 months. Study 018 was an 18-month extension of 016 trial where 80% patients completed the study. This may suggest that safinamide 100 mg can be a long-term treatment that will delay medication adjustment in PD.

Methods: In this retrospective study reviewing the patients treated in our clinical practice with 100 mg safinamide as add-on to levodopa, we evaluate the time to an additional antiparkinsonian drug intervention.

Results: We have 70 patients with 100 mg safinamide daily with an average time of 12 months follow up. Among them, 87.14% (n=61) remain in treatment without any adjustment in levodopa or in other concomitant medications since the beginning of 100 mg safinamide treatment. Only 9 patients required a medication adjustment (12.86%, n=9) and the average time for additional antiparkinsonian drug intervention was 6 months. In 4 patients an ICOMT was added and in 5 patients we increased the dopamine agonist.

Conclusions: Safinamide 100 mg has shown long-term efficacy and safety in our clinical practice, being a PD medication that could delay an additional antiparkinsonian drug intervention.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/maintenance-of-safinamide-100-mg-daily-long-term/