Safinamide 50mg tablets

Abstract Introduction: Parkinson’s disease (PD) involves the progressive loss of dopaminergic neurons, leading to motor and non-motor symptoms that significantly impact patients’ quality of life. Safinamide modulates dopaminergic and glutamatergic systems, offering a promising treatment approach. Methods: This meta-analysis evaluated the efficacy of safinamide as an add-on therapy to levodopa for PD patients with motor fluctuations. Following PRISMA guidelines, literature searches were conducted in PubMed and Embase (2014–2022). Inclusion criteria were studies on adult PD patients receiving safinamide with levodopa. Outcomes included on-time without troublesome dyskinesia, off-time, UPDRS Part III motor scores, UPDRS Part II activities of daily living scores, PDQ-39 emotional well-being, and GRID-HAMD scores. Results: Among thirteen eligible studies, safinamide significantly improved on-time without troublesome dyskinesia at 100 mg/day (mean difference [MD]: −0.90; 95% CI: −1.12 to −0.67; p < 0.00001) and 50 mg/day (MD: −0.77; 95% CI: −1.21 to −0.34; p = 0.0005) compared to placebo. It also reduced off-time (100 mg/day: MD: −0.94; 95% CI: −1.19 to −0.70; p < 0.00001; 50 mg/day: MD: −0.72; 95% CI: −1.03 to −0.41; p < 0.00001) and improved UPDRS-III motor scores (100 mg/day: MD: −3.01; 95% CI: −4.15 to −1.86; p < 0.00001; 50 mg/day: MD: −2.93; 95% CI: −5.14 to −0.71; p = 0.001). Mood improvements were noted in PDQ-39 emotional well-being scores (MD: −5.22; 95% CI: −6.90 to −3.54) and GRID-HAMD scores (MD: −0.60; 95% CI: −0.95 to −0.25; p = 0.0009). Safinamide also positively affected pain (RR: 1.10; 95% CI: 1.03 to 1.18). Conclusion: Compared to placebo, safinamide significantly benefits motor and non-motor symptoms in PD patients, but further research is necessary to fully explore its therapeutic potential.

Abstract licence: CC BY-NC 4.0

ObjectiveSleep disturbances are common and debilitating nonmotor symptoms (NMS) in Parkinson's disease (PD) patients and profoundly affect quality of life. Despite emerging evidence suggesting that monoamine oxidase B (MAO-B) and catechol-O-methyltransferase (COMT) inhibitors may alleviate NMS, their specific effects on sleep remain unclear. The aim of this network meta-analysis (NMA) was to compare the efficacy of these inhibitors related to sleep problems in PD patients.MethodsFollowing a systematic search of PubMed, Cochrane, and Embase, studies comparing MAO-B or COMT inhibitors and assessing sleep outcomes in PD patients were identified. An NMA was conducted using data from the seven studies that met our inclusion criteria. The outcomes included subjective sleep quality, daytime sleepiness, and objective polysomnography (PSG) parameters.ResultsNo statistically significant differences were found between the effects of the MAO-B and COMT inhibitors on improving subjective sleep quality or daytime sleepiness. However, analyses of objective PSG data revealed that, compared with rasagiline and placebo, safinamide significantly increased rapid eye movement sleep duration (mean difference, 5.70 min [95% CI, 2.26 to 9.14]) and decreased wake time after sleep onset (mean difference, -10.20 min [-19.38 to -1.02]).ConclusionThese findings suggest that safinamide may offer additional value for managing sleep disruptions beyond its known motor benefits in patients with PD. Given the limited number and small scale of available trials, the overall evidence should be interpreted cautiously. Nonetheless, this analysis highlights the need for future high-quality trials focused on sleep outcomes to guide the personalized use of MAO-B and COMT inhibitors for sleep disturbances in PD patients.

Abstract licence: CC BY-NC

Background: Safinamide, a recently developed drug with several mechanisms of action has been investigated as an add-on therapy for Parkinson's disease patients suffering from motor complications due to the usage of anti-Parkinson's medications such as levodopa and dopaminergic drugs. The aim of the study is to investigate the efficacy and safety of Safinamide as add-on therapy for Parkinson's disease patients.   Methods: A computerized literature search was conducted of PubMed, EMBASE, ClinicalTrial.gov and Cochrane Library until August 2019. We selected relevant randomized controlled trials comparing safinamide groups to placebo groups. Relevant outcomes were pooled as mean difference (MD) and risk ratio (RR) using Review Manager 5.3. Results: We found that the overall MD of changes in “off-time” and “on time without troublesome dyskinesia” favored the safinamide group over the placebo group (MD -0.72 h, 95% CI -0.89 to -0.56 and MD 0.71 h, 95% CI 0.52 to 0.90, respectively). Additionally, the overall MD of change in Unified Parkinson's Disease Rating Scale part three (UPDRS III) favored the safinamide group (MD -1.83, 95% CI -2.43 to -1.23). In case of adverse events, the pooled meta-analysis did not favor the safinamide group over the placebo group. Conclusions: In this study, we provide class I evidence about the potential role of safinamide as an add-on therapy for Parkinson's disease patients suffering from motor fluctuations. However, a few included studies did not mention the data of important outcomes. Also, we report high risk of bias in individual studies. Future randomized controlled trials with different doses are recommended to provide more evidence for the efficacy and safety of safinamide as a treatment for motor complications of anti-Parkinson's medications.

Abstract licence: CC BY 4.0