Discussion
tremor, rigidity, PD, PIGD, dyskinesia, postural instability gait disorder
DISABLING DISEASE, DISEASE, DYSKINESIA
This is the first publication that analyzes the potential sex differences in term of drug efficacy and safety in Chinese PD patients.Motor fluctuations are defined as a rapid transition between good and poor response to medications. They are indicated by PD patients as the most disabling disease feature, even worse than dyskinesia. About 50% of subjects develop fluctuations after 2 years of disease, and this percentage increase up to 80% after 5 years, becoming more intense and unpredictable, with a significant economic burdenSafinamide, compared to placebo, significantly reduced OFF time, increased ON time (total and without dyskinesia) in both genders, therefore indicating that may also improve the quality of the ON time. This effect might be explained by the activity of safinamide on glutamate modulationSafinamide improved three out of four PD cardinal symptoms except PIGD (postural instability gait disorder), which is known to be less responsive to drug treatments. In particular, safinamide reduced tremor in females and rigidity in males, the two peculiar gender features of PDPicillo et al.Consequently, there was an improvement in patients’ quality of life, as reflected by the PDQ-39 scale, a validated disease-specific questionnaireThese findings have been confirmed in our study where the improvements after safinamide treatment were higher in females in the socio-emotional domains (“Activities of daily living”, “Emotional well-being”, “Stigma” and “Bodily discomfort”), and in males in the physical-functioning domains (“Mobility and Communication”) (Fig. There are some limitations that should be considered in the interpretation of these data, in particular the sample size limitation and the trial design not considering an active comparator arm and thus preventing a direct comparison with other PD drugs. Moreover, this is a post-hoc analysis and the objectives were not predefined.