Objective: To evaluate in a real-world experience high doses of safinamide in patients with fluctuating Parkinson’s disease (PD).

Background: Standard doses of safinamide (50-100 mg) have proved efficacious as an add-on treatment to levodopa in fluctuating Parkinson’s disease (PD). Glutamatergic modulation with safinamide 100 mg seems to increase with higher doses, whose safety has been proved in preclinical trials.

Method: Retrospective analysis of electronic records of PD patients treated with safinamide >100 mg (April 2019-December 2019).

Results: Fifteen PD fluctuating patients, with insufficient motor control with safinamide 100 mg daily, 10 (66.6%) male, median age 74 (IQR 16), disease duration 13 years (IQR 10), Hoehn-and-Yahr stage 3 (IQR 2), who were switched to 150 mg (4) or 200 (11) mg safinamide daily, and followed a median of 3 months (IQR 5) were analysed. Four patients were treated with DBS (26.7%). UPDRS IV scores significantly improved (8.2±3.4 vs 6.3±2.2, p=0.007), mainly due to off duration (2±0.8 vs. 1.3±0.5, p=0.013). Nine patients (60%) had a Clinical Global Impression of improvement (CGI 1-3): in 8 cases regarding off duration, in 3 cases regarding dyskinesia duration, in 4 in functional impact of dyskinesia and in 2 in pain due to dyskinesia. In one patient levodopa doses were decreased. Three patients (20%) had mild-moderate adverse events leading to suspension of the drug in 2 (both due to dyskinesia worsening). One patient discontinued safinamide 200 mg because she was started on levodopa/carbidopa intestinal infusion.

Conclusion: In our real clinical practice experience with advanced PD patients, higher doses of safinamide significantly improved motor fluctuations as measured by UPDRS IV, being overall well tolerated.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/efficacy-and-safety-of-high-doses-of-safinamide-in-advanced-parkinsons-disease-patients-in-a-real-world-experience/