Objective: Aim of this retrospective study is to evaluate safety and efficacy of safinamide in the treatment of motor complications in patients with Parkinson’s Disease (PD) and Subthalamic Nucleus Deep Brain Stimulation (DBS).

Background: Safinamide, a monoamino oxidase B and glutamate release inhibitor, demonstrated to be safe and effective for the treatment of motor complications in PD, with a significant improvement in daily ON time without dyskinesias and a significant reduction of levodopa equivalent daily dose (LEDD).

Methods: Nineteen DBS PD patients (mean age 63.5 years ± 9; 7 women, disease duration 15.8 years ± 7), who were prescribed safinamide for motor complications, were evaluated prior to starting the drug, after 6 months and at the last available follow up. Evaluations consisted in: Unified Parkinson’s Disease Scale part III (UPDRS), Hoehn & Yahr (HY), Unified Dyskinesia Rating Scale (UDysRS) walking and balance item 9 score, daily time spent in OFF and in ON with disabling dyskinesias (one week diary), mean daily dose of levodopa (LD), dopamine-agonists (DA), catechol-O-methyl transferase inhibitor (COMT-I), monoamine oxidase B inhibitor (MAOB-I), and their LEDD.

Results: Three patients withdrew safinamide after 3, 6, and 8 months for minor side effects. At the six months evaluation, the remaining 16 PD patients showed a significant improvement of all the scales scores, except for HY, a significant reduction of the daily dosages of all the drugs and of the time spent in OFF and in ON with disabling dyskinesias. At the last evaluation, after a mean time with safinamide of 17.43 months ± 3,6, a significant reduction of daily time spent in OFF and in ON with disabling dyskinesia was still present. As a consequence, the significant reduction of the daily dose of DA and COMT-I. LEDD was not increased and the scale scores remained stable respect to basal values.

Conclusions: Safinamide is safe and effective in improving motor complications of DBS PD patients, maintaing its efficacy on motor complications after 17 months of therapy.

References: Mancini F, Di Fonzo A, Lazzeri G, Borellini L, Silani V, Lacerenza M, Comi C. Real life evaluation of safinamide effectiveness in Parkinson’s disease. Neurol Sci. 2018 Feb 13. doi: 10.1007/s10072-018-3272-y. [Epub ahead of print]. Cruz MP. Xadago (Safinamide): A Monoamine Oxidase B Inhibitor for the Adjunct Treatment of Motor Symptoms in Parkinson’s Disease. P T. 2017 Oct;42(10):622-637.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/safinamide-effect-in-patients-with-parkinsons-disease-and-deep-brain-stimulation/