Effectiveness of Safinamide over Mood in Parkinson’s Disease Patients: Secondary Analysis of the Open-label Study SAFINONMOTOR

Abstract

Introduction Mood disorders are frequent in Parkinson’s disease (PD) and a favorable effect of safinamide on mood has been observed. We aimed to analyze the effectiveness of safinamide on mood as a secondary objective from the SAFINONMOTOR (an open-label study of the effectiveness of SAFInamide on NON-MOTOR symptoms in patients with Parkinson’s disease) study. Methods SAFINONMOTOR is a prospective open-label single-arm study conducted in five centers from Spain. Patients with PD were required to have at baseline a Non-Motor Symptoms Scale (NMSS) total score of at least 40. In this analysis, the changes from V1 (baseline) to V4 (6 months ± 1 month) in the BDI-II (Beck Depression Inventory-II), NMSS mood/apathy domain, and PDQ-39 (Parkinson’s Disease Questionnaire-39) emotional well‐being domain were analyzed. Depression was identified and classified (DSM-IV and Judd criteria) at baseline and at the end of follow-up as major depression (MD), minor depression (mD), subthreshold depression (subD), and non-depression (nonD). Results Fifty patients with PD were included (age 68.5 ± 9.12 years; 58% women; 6.4 ± 5.1 years from diagnosis) and 44 patients (88%) completed the follow-up at 6 months. The BDI-II total score was reduced by 35.9% (from 15.88 ± 10.46 at V1 to 10.18 ± 6.76 at V4; p < 0.0001). A significant decrease in the NMSS mood/apathy domain and PDQ-39 emotional well‐being domain was observed as well ( p < 0.0001). At baseline, 52% of the patients presented MD, 34% mD, 12% subD, and 2% nonD whereas at V4 the percentages were 31.8%, 34.1%, 22.7%, and 11.4%, respectively ( p = 0.029). Conclusions Safinamide improves mood in patients with PD at 6 months. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-021-01873-w.

Clinical benefit of MAO-B and COMT inhibition in Parkinson’s disease: practical considerations

“…Additional indirect evidence of positive effects of safinamide on pain in PD stem from a post hoc analysis of the combined “016” and SETTLE study, as well as the “018” extension study, demonstrating less frequency of concomitant therapy with analgesics in the safinamide group compared to placebo (Cattaneo et al 2016 , 2018 ). The Spanish descriptive, observational, longitudinal, prospective open-label study SAFINONMOTOR recruited 50 PD patients with an NMSS ≥ 40, and showed improvement of mood-related items on the NMSS and the PDQ-39 as well as sleep-related scores of the PSQI and the Epworth Sleepiness Scale (Labandeira et al 2021 ; García et al 2022a ). Finally, in a randomized, longitudinal, cross-over study of 30 PD patients with REM sleep behavioral disorder in PD, improvement in sleep was reported in a subset of patients (Plastino et al 2021 ).…”

Non-motor symptoms burden in motor-fluctuating patients with Parkinson’s disease may be alleviated by safinamide: the VALE-SAFI study

“…Moreover, the items related to sleep and fatigue, mood, apathy, attention and memory, gastrointestinal and urinary symptoms, and pain were significantly reduced at the follow-up (García et al 2021b). Following this report, other results have been published from this multi-centre study, but separately analysed, documenting an improvement of sleep, daytime sleepiness, depression, and pain (García et al 2021a;Labandeira et al 2021;Santos García et al 2021). Considering the importance of a comprehensive and prospective analysis including an homogeneous large sample of motor-fluctuating PD patients treated by safinamide as add-on treatment to LD, the present study collectively evaluated all these NMS at baseline and after 6 months of stable treatment in a group of sixty motorfluctuating PD patients.…”

“…Aside from motor symptoms improvement, different recent reports demonstrated a significant effect of safinamide on NMS (Bianchi et al 2019 ; Geroin et al 2020 ; De Micco et al 2021 ; Grigoriou et al 2021 ; Peña et al 2021 ). The single open-label prospective study on different NMS performed in Spain included fifty PD patients but not all were treated with safinamide as an add-on treatment to LD (García et al 2021a , b ; Labandeira et al 2021 ; Santos García et al 2021 ). The first published result showed the significant reduction of NMSS global score after 6 months of safinamide treatment in PD patients.…”

Fatigue in fluctuating Parkinson’s disease patients: possible impact of safinamide

“…Safinamide has been proved effective in improving motor functions and fluctuations in fluctuating PD patients, and more recently, many reports demonstrated its role also in reducing non-motor symptoms, such as mood fluctuations, sleep disturbances or chronic pain (Cattaneo et al 2017 ; Geroin et al 2020 ; Abbruzzese et al 2021 ; Labandeira et al 2021 ; Santos García et al 2022 ).…”