Safinamide Improves Non-Motor Symptoms Burden in Parkinson's Disease: An Open-Label Prospective Study.

Diego Santos García,Maria Gemma Alonso Losada,Maria Icíar Cimas Hernando,Carmen Labandeira Guerra,Rosa Yáñez Baña,Iria Cabo López,María José González Palmás,Jose Manuel Paz Gonález,Cristina Martínez Miró

doi:10.3390/brainsci11030316

Abstract

Some studies observed a benefit of Parkinson’s disease (PD) patients after treatment with safinamide in some non-motor symptoms (NMSs). The aim of this study was to analyze the effectiveness of safinamide on NMS burden in PD. SAFINONMOTOR (an open-label study of the effectiveness of safinamide on non-motor symptoms in Parkinson’s disease patients) is a prospective open-label single-arm study conducted in five centers from Spain. The primary efficacy outcome was the change from baseline (V1) to the end of the observational period (6 months) (V4) in the non-motor symptoms scale (NMSS) total score. Between May/2019 and February/2020 50 patients were included (age 68.5 ± 9.12 years; 58% females; 6.4 ± 5.1 years from diagnosis). At 6 months, 44 patients completed the follow-up (88%). The NMSS total score was reduced by 38.5% (from 97.5 ± 43.7 in V1 to 59.9 ± 35.5 in V4; p < 0.0001). By domains, improvement was observed in sleep/fatigue (−35.8%; p = 0.002), mood/apathy (−57.9%; p < 0.0001), attention/memory (−23.9%; p = 0.026), gastrointestinal symptoms (−33%; p = 0.010), urinary symptoms (−28.3%; p = 0.003), and pain/miscellaneous (−43%; p < 0.0001). Quality of life (QoL) also improved with a 29.4% reduction in the PDQ-39SI (from 30.1 ± 17.6 in V1 to 21.2 ± 13.5 in V4; p < 0.0001). A total of 21 adverse events in 16 patients (32%) were reported, 5 of which were severe (not related to safinamide). Dyskinesias and nausea were the most frequent (6%). Safinamide is well tolerated and improves NMS burden and QoL in PD patients with severe or very severe NMS burden at 6 months.

Highlights

Four patients initially selected were excluded for different reasons: three for presenting a non-motor symptoms scale (NMSS) total score < 40 and one due to have already started with safinamide at V1
The NMSS total score was reduced by 38.5% (Table 2)
Parkinson’s disease (PD) patients had to present with severe or very severe nonmotor symptoms (NMS) burden (NMSS total score > 40) for being included, but the indication of starting with safinamide was according to the neurologist opinion in clinical practice

Summary

Introduction

Alzheimer’s disease, is a progressive neurodegenerative disorder causing motor and nonmotor symptoms (NMS) that result in disability, loss of patient autonomy and caregiver burden [1]. With respect to pharmacological treatment, levodopa is the gold standard treatment for PD but other medications are useful: dopamine agonists, COMT inhibitors or MAO-B inhibitors [2]. Safinamide is an oral α-aminoamide derivate marketed for the treatment of PD with both dopaminergic properties, namely highly selective and reversible inhibition of MAO-B, and nondopaminergic properties, namely selective sodium channel blockade and calcium channel modulation, with consequent inhibition of excessive 4.0/). In 2014, safinamide was approved in the European Economic Area, as “an add-on therapy” to stable dose of levodopa, alone or in combination with other PD therapies in fluctuating PD patients. In PD trials, addition of safinamide to levodopa has demonstrated to improve both motor scores and duration of “on time” similar to other

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