Abstract
Safinamide is an approved drug for the treatment of motor fluctuations in Parkinson’s disease (PD). Scarce data are available on its use in clinical practice. A group of Spanish movement disorders specialists was convened to review the use of safinamide across different clinical scenarios that may guide neurologists in clinical practice. Eight specialists with recognized expertise in PD management elaborated the statements based on available evidence in the literature and on their clinical experience. The RAND/UCLA method was carried, with final conclusions accepted after a 2-round modified Delphi process. Higher level of agreement between panellists was reached for the following statements. Safinamide significantly improves mean daily OFF time without troublesome dyskinesias. Adjunctive treatment with safinamide is associated with motor improvements in patients with mid-to-late PD. The efficacy of safinamide on motor fluctuations is maintained at long-term, with no increase over time in dyskinesias severity. The clinical benefits of safinamide on pain and depression remain unclear. Safinamide presents a similar incidence of adverse events compared with placebo. The efficacy and safety of safinamide shown in the pivotal clinical trials are reproduced in clinical practice, with improvement of parkinsonian symptoms, decrease of daily OFF time, control of dyskinesias at the long term, and good tolerability and safety.
Highlights
The management of Parkinson’s disease (PD) has improved over the last 20 years with the development of different families of dopaminergic drugs with specific mechanisms of action
Questionnaire-39 (PDQ-39) of the bodily discomfort domain. This exploratory analysis presents some limitations, the results showed the beneficial effect of safinamide 100 mg/day on pain, with 79.7% of the improvement being directly attributed to the intrinsic effect of safinamide [26]
A retrospective study has recently shown that patients treated with safinamide significantly reduced the pain item of the Parkinson’s Disease Questionnaire-8 (PDQ-8), but there are no published studies showing a significant improvement by safinamide in specific pain scales [27]
Summary
The management of Parkinson’s disease (PD) has improved over the last 20 years with the development of different families of dopaminergic drugs with specific mechanisms of action. Dopamine agonists (DA), in monotherapy or combination with levodopa, are associated with a reduction and delay in the development of motor fluctuations and dyskinesias [1]. Despite the use of dopaminergic drugs, patients develop motor fluctuations and/or dyskinesias, treatment with Monoamine oxidase B (MAO-B) inhibitors (safinamide, rasagiline, or selegiline), Catechol-O-Methyl-Transferase (COMT) inhibitors (opicapone, entacapone, or tolcapone), subcutaneous apomorphine, amantadine, and/or zonisamide is recommended [2]. Besides the selective inhibition of MAO-B, safinamide can modulate glutamate release via sodium channel blockade and calcium channel modulation [3]. This dual mechanism of action results in the increased availability of dopamine within the striatum and the decreased release of glutamate in regions with glutamatergic hyperexcitability [4]
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