Objective: Evaluate the efficacy of safinamide in fluctuations in Parkinson’s disease in real life. Analysis by subgroups: Switch rasagiline to safinamide and treatment with low doses of safinamide.

Background: Management of motor fluctuations in Parkinson Disease can be challenging, and include use of MAO-B inhibitors, COMT inhibitor, dopamine agonist or change levodopa schedule. We present a prospective observational-real life study about the use of safinamide in  PD patients in our Movement Disorders Unit

Method: We evaluate safinamide´s effects in 93 patients (52.7% women, mean age 67.8 years (SD 10.9), disease duration 8.3 (SD 5.5), in combinated therapy with levodopa and dopamine agonists 68.8%, entacapone 29.03%, opicapone 16.12% and advanced therapies 2.1%. 52,7% patients had treated with rasagiline previously. Basal UPDRS-III 24,72. 68,8% patients stage II Hoehn&Yahr. Motor complications were: morning-akinesia 66,7%, wearing-OFF 65,6%, unpredictable-OFF 8,7% and night-akinesia 19,4%. Change was evaluated with UPDRS-III, presence/severity of fluctuations-dyskinesias through diaries and Global Clinical Scale-CGI. In addition, an analysis by subgroups has been carried out: previous treatment with rasagiline and treatment with low doses of safinamide.

Results: 90 patients completed the study at 6 months (3 dropped out due to adverse effects (headache, dizziness)) observing a statistically significant decrease in morning akinesia (67,7% vs 33,4%; p=0,001), wearing-OFF (65,6% vs 31,2% p>0.001), night akinesia (19,4% vs 8,1%; p=0.003), unpredictable-OFF (8,7% vs 6,5%; p=0.03) and UPDSR (24,72 vs 20,28; p<0,001). Dyskinesias don´t change. About 67.8% of patients report finding themselves better, 28.9% similar and 3.3% worse with the adition of safinamide. In the group of 49 patients who switch rasagiline to safinamide and the group of 45 patients treatment with Safinamide 50mg/24h, morning akinesia, wearing-OFF and UPDSR improve were statistically significant.

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 or in patients treatment with low safinamide doses (50mg/24h)

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MDS Abstracts - https://www.mdsabstracts.org/abstract/safinamide-real-life-study-efficacy-in-switch-from-rasagilina-and-low-dose-treatment/