Efficacy of Safinamide and Gender Differences During Routine Clinical Practice

Abstract

Background: There is increasing evidence of gender differences in the epidemiology and clinical manifestation of both motor and non-motor symptoms of Parkinson's disease (PD). Nevertheless, few data are available on gender differences in the response to antiparkinsonian drugs. Safinamide is a multimodal drug with positive effects on motor and non-motor fluctuations that might improve patients' care and quality of life.Objective: To analyze gender differences on clinical effects of safinamide in PD patients treated in real-life conditions during the SYNAPSES trial.Methods: SYNAPSES was a multinational, multicenter, observational study. At baseline, patients with PD diagnosis received safinamide as an add-on to levodopa and were followed up for 12 months, with visits performed every 4 months. A new statistical analysis was performed to describe the efficacy of safinamide in men and women on motor complications, motor symptoms, and adverse events.Results: Six hundred and sixteen (38%) out of 1,610 patients enrolled in the SYNAPSES study were women and 994 (62%) men. Safinamide improved motor symptoms and motor complications (fluctuations and dyskinesia) in both genders, with a good safety profile and without requiring any change in the concomitant dopaminergic therapy. Clinically significant improvements, according to the criteria developed by Shulman et al., were seen in 46% of male and female patients for the UPDRS motor score and 43.5% of men vs. 39.1% of women for the UPDRS total score.Conclusions: Safinamide was effective in improving motor fluctuations and dyskinesia and proved to be safe in both male and female patients with PD. Further prospective studies, specifically addressing potential gender differences in response to PD therapies, are needed to develop tailored management strategies.

Sex Differences in Motor and Non-Motor Symptoms among Spanish Patients with Parkinson’s Disease

“…Sex-related differences have been documented in several aspects of PD, including motor features, response to levodopa, NMSs, and QoL, among others [ 1 , 2 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 35 , 36 , 37 , 38 , 39 ]. Motor symptoms emerge later in women, including specific characteristics such as reduced rigidity [ 6 , 40 , 41 ] but also more risk of falling [ 11 , 41 ], as we found. On the contrary, speech problems, in line with our findings, freezing of gait, and drooling are more associated with male sex [ 1 , 2 , 11 , 42 , 43 ].…”

Sex and Gender Differences in Neurodegenerative Diseases: Challenges for Therapeutic Opportunities

“…A higher prevalence of dyskinesia in women at baseline after treatment with safinamide was also reported. However, a similar reduction of patients with dyskinesia in both genders over a 1-year follow-up was observed, and the prevalence of any fluctuations was similarly reduced in both females and males after safinamide introduction [ 68 ].…”

Sexu-desberdintasunak Parkinson gaixotasunean

“…-n [98] ikerketaren arabera, safinamidaren preskripzioa egin eta urtebeteko jarraipen batekin, gizon eta emakumeek antzerako erantzuna erakutsi zuten fluktuazio motoren murrizketan.…”

“…Orokorrean, farmako honen tolerantzia ona den arren, emakumeek eragin kaltegarri gehiago pairatzen dute; zehazki, sintoma gastrointestinal eta ortostatikoak [100]. Aldiz, safinamidaren eragin kaltegarrietan ez da desberdintasunik deskribatu [98]. Azkenik, farmako dopaminergikoen eragin kaltegarriekin lotutako hainbat sintoma maizago agertzen dira gizonetan emakumeetan baino, hala nola, ludopatia, hipersexualitatea [101] eta eguneko hipersomnia [65].…”