Safinamide in Clinical Practice: A Spanish Multicenter Cohort Study

Abstract

Background: Safinamide is an approved drug for the treatment of motor fluctuations of Parkinson’s Disease (PD) patients with a potential benefit on non-motor symptoms (NMS). Methods: A retrospective multicenter cohort study was conducted, in which the clinical effect of safinamide on both motor and NMS was assessed by the Clinical Global Impression of Change scale. Furthermore, we assessed the appearance of adverse events (AEs) and its effect on dyskinesia, that were also recorded in non-fluctuating PD patients and in those previously treated with rasagiline. Results: We included 213 PD patients who received safinamide in addition to their regular levodopa therapy. Thirty-five withdrew prematurely from safinamide, mainly because of AEs. Out of 178, clinical improvement on motor and NMS was found in 76.4% and 26.2%, respectively. A total of 44 reported AEs of mild intensity. We did not find a difference concerning the clinical benefit or AEs when comparing either patients who had or had not been taking Monoamine Oxidase B Inhibitor (MAOB-I) previously or between patients with and without motor complications. Conclusions: Safinamide is an effective and safe add-on to levodopa drug for PD patients. Moreover, safinamide could elicit an additional clinical improvement in PD patients previously treated with other MAOB-I and in non- fluctuating patients with suboptimal motor control.

Impact of SAfinamide on Depressive Symptoms in Parkinson’s Disease Patients (SADness-PD Study): A Multicenter Retrospective Study

“…We found safinamide to be well tolerated in real conditions, even when co-administered with antidepressants, which is in consonance with previous reports [ 30 , 32 ]. Overall, the relative frequencies of major and minor symptoms associated with serotonin syndrome were low, without significant differences between the safinamide-only and safinamide + antidepressants groups.…”

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

“…Safinamide was not only effective but also safe and well-tolerated. The results about adverse events are in line with other studies [ 5 , 6 , 7 , 8 , 9 , 10 , 37 , 38 , 39 , 40 , 41 , 46 , 47 , 48 , 50 , 51 , 52 , 53 , 54 ]. With regards to this point, a recent study conducted in 1610 PD patients demonstrated a good safety profile of safinamide even in special groups [ 53 ].…”

A Spanish Consensus on the Use of Safinamide for Parkinson’s Disease in Clinical Practice

“…Martí et al recently conducted a retrospective-prospective cohort study on 213 PD patients who started safinamide treatment (54% previously on rasagiline), showing an improvement in motor function without worsening of dyskinesias. The incidence of AEs was not significantly different between patients previously treated with rasagiline and those starting directly with safinamide [38,39].…”

“…Despite some evidence, there is no standardized procedure for the switch from rasagiline to safinamide as only three observational studies and one expert consensus have addressed this issue before [13,23,24,38].…”

“…In the expert consensus, some neurologists recommend a washout period of two weeks (according to licensing recommendations), others advocate for a shorter washout period, and others to start safinamide treatment immediately after rasagiline withdrawal [24]. In the retrospective study of Martí et al, patients underwent an overnight switch from rasagiline to safinamide with no significant AEs [38]. Regarding the starting dosage of safinamide after rasagiline withdrawal, two strategies were suggested: (1) a starting dosage of 50 mg/day with the potential increase to 100 mg/day when no AEs develop and efficacy is not achieved, or (2) a starting dosage of 100 mg/day since previously published studies did not report significant differences in terms of AEs between these two dosages [6,25].…”