Abstract
Background
Safinamide, as a levodopa adjunct, is effective in reducing motor fluctuations in Parkinson’s disease (PD) patients; however, scarce evidence is available regarding its use in older PD patients.
Aim
To evaluate the safety and tolerability of safinamide as an adjunct therapy in patients aged ≥ 60 years with advanced PD.
Methods
A retrospective study including 203 PD patients admitted to a geriatric day hospital, who were evaluated following an extensive clinical protocol. Safinamide use was categorized as never used, ongoing, and withdrawn. Potential correlations of Safinamide withdrawal were investigated in stepwise backward logistic regression models.
Results
A total of 44 out of 203 participants were current or former users of Safinamide. Overall, 14 (32%) patients discontinued due to treatment-emergent adverse events (TEAEs). Withdrawal was not associated with older age.
Conclusions
Safinamide as an adjunct therapy in patients aged ≥ 60 years with advanced PD was found to be safe and well-tolerated in older patients. There were no specific demographic or clinical characteristics associated with suspension.
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The study protocol was reviewed and approved by the Ethics Committee of Fondazione Policlinico Universitario “Agostino Gemelli,” IRCCS, Catholic University of the Sacred Heart, Rome, Italy. The study was carried out in agreement with legal requirements and international norms. All procedures performed in this study were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki Declaration and its later amendments.
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Lo Monaco, M.R., Petracca, M., Vetrano, D.L. et al. Safinamide as an adjunct therapy in older patients with Parkinson’s disease: a retrospective study. Aging Clin Exp Res 32, 1369–1373 (2020). https://doi.org/10.1007/s40520-020-01469-4
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DOI: https://doi.org/10.1007/s40520-020-01469-4