Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Dec 14:12:756304.
doi: 10.3389/fneur.2021.756304. eCollection 2021.

Efficacy of Safinamide and Gender Differences During Routine Clinical Practice

Maria T Pellecchia  1 , Marina Picillo  1 , Maria C Russillo  1 , Maria F De Pandis  2 , Erminio Bonizzoni  3 , Ivan Marjanovic  4 , Carlo Cattaneo  4
Affiliations

Efficacy of Safinamide and Gender Differences During Routine Clinical Practice

Maria T Pellecchia et al. Front Neurol. .

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.

Keywords: Parkinson's disease; gender differences; motor fluctuations; real-life evaluation; safinamide.

PubMed Disclaimer

Conflict of interest statement

MTP, MP, MR, and MD are members of the Scientific Advisory Board of Zambon S.p.A. CC and IM are employees at Zambon S.p.A. EB is a statistical consultant for Zambon S.p.A. Zambon S.p.A. was involved in the study design and collection of data for the original study. Zambon S.p.A funded the original study. CC requested approval for publication from Zambon S.p.A as an employee but Zambon S.p.A was not involved in the analysis, interpretation of data, writing of this article, or the decision to submit it for publication.

Figures

Figure 1
Figure 1
Safinamide is a multi-modal drug with a double mechanism of action.
Figure 2
Figure 2
UPDRS scores (part II, III, IV, total scores) at each study visit (± SE). UPDRS, Unified Parkinson's Disease Rating Scale; SE, Standard Error.
Figure 3
Figure 3
Percentage of male and female patients with clinically important difference (improvement) in the UPDRS scores (difference between 12-months follow-up and baseline). UPDRS, Unified Parkinson's Disease Rating Scale.
Figure 4
Figure 4
Any fluctuations (A) and wearing-off (B): proportion of patients by gender and visits. SE, Standard Error. *p = 0.0210 (difference between female and male proportions at follow-up visits adjusted for the difference between female and male proportions at baseline).
Figure 5
Figure 5
Dyskinesia: Proportion of patients by gender and visits. SE, Standard Error.
See this image and copyright information in PMC

References

    1. Dexter DT, Jenner P. Parkinson disease: from pathology to molecular disease mechanisms. Free Radic Biol Med. (2013) 62:132–44. 10.1016/j.freeradbiomed.2013.01.018 - DOI - PubMed
    1. Postuma RB, Aarlsland D, Barone P, Burn DJ, Hawkes CH, Oertel W, et al. . Identifying prodromal Parkinson's disease: pre-motor disorders in Parkinson's disease. Mov Disord. (2012) 27:617–26. 10.1002/mds.24996 - DOI - PubMed
    1. Baldereschi M, Di Carlo A, Rocca WA, Vanni P, Maggi S, Perissinotto E, et al. . Parkinson's disease and parkinsonism in a longitudinal study: two-fold higher incidence in men. ILSA Working Group. Italian Longitudinal Study on Aging. Neurology. (2000) 55:1358–63. 10.1212/WNL.55.9.1358 - DOI - PubMed
    1. Kaasinen V, Joutsa J, Noponen T, Johansson J, Seppänen M. Effects of aging and gender on striatal and extrastriatal [123I]FP-CIT binding in Parkinson's disease. Neurobiol Aging. (2015) 36:1757–63. 10.1016/j.neurobiolaging.2015.01.016 - DOI - PubMed
    1. Haaxma CA, Bloem BR, Borm GF, Oyen WJ, Leenders KL, Eshuis S, et al. . Gender differences in Parkinson's disease. J Neurol Neurosurg Psychiatry. (2007) 78:819–24. 10.1136/jnnp.2006.103788 - DOI - PMC - PubMed

LinkOut - more resources