Objective: The aim of the study is to evaluate the efficacy, safety and tolerability of SF (50 and 100 mg / day) in elderly patients (> 75 years) with motor and non-motor fluctuations, compared to patients aged 65-75 years.

Background: Safinamide (SF) is a reversible MAO-B-inhibitor, with therapeutic indication as add-on to levodopa in fluctuating Parkinson’s disease patients. The majority of subjects enrolled in registrative studies with SF were aged <70 years. Consequently, data on the efficacy, safety and tolerability of SF in elderly patients are rather poor.

Method: Twenty-eight PD patients aged 65-75 years, and 23 patients aged >75 were enrolled consecutively at our PD unit. Fluctuations were identified by means of a ≥3 score at the WOQ-19, and SF was started the day next to the visit. Daily SF dose was 50 mg (n=26) or 100 mg (n=25).  We excluded patients with dementia, history of hallucinations in the past six months, disabling dyskinesia, disabling orthostatic hypotension and poor compliance.

Results: At 6-months follow-up, the majority of subjects displayed efficacy on fluctuations, with no significant difference between groups. Moreover, adverse events were rated as mild and were similarly infrequent in both groups. Eventually, there were no significant differences in terms of safety between the 50 and 100 mg daily SF doses.

Conclusion: This is the first study investigating the efficacy, safety and tolerability of SF in PD patients aged >75 years. Our results indicate that the drug maintains clinical efficacy and is safe and tolerable in elderly PD subjects.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/a-pilot-study-on-the-efficacy-tolerability-and-safety-of-safinamide-in-elderly-parkinsons-disease-patients/