Objective: This study aimed to characterize the safety profile of opicapone (OPC) in the elderly and compare post-marketing safety between (A) very elderly patients (≥ 85 years) and (B) elderly patients (65-84 years).

Background: OPC is used as an adjunct to levodopa in Parkinson’s disease (PD) patients with end-of-dose motor fluctuations. Clinical studies have shown a good tolerability in elderly patients. However, very elderly patients (≥85 years) are often excluded from clinical trials, limiting safety data. Real-world safety information is of utmost importance to confirm the tolerability in this group.

Method: All valid post-marketing reports (spontaneous, from health authorities, literature, non-interventional studies) for patients aged ≥65 years old in the OPC global safety database were retrieved from the market launch in March 2016 to December 2024. Two elderly patient sub-groups were created for comparison: (A) very elderly patients (≥85 years) and (B) elderly patients (65-84 years). Expectedness was assessed based on the latest European Summary of Product Characteristics for OPC.

Results: Our results in elderly showed similar safety profile of OPC as in overall population. In the very elderly group (A), 354 AEs were collected from 161 valid safety reports: 55.9% female, 42.2% male, 1.8% unknown. Regarding group (B), 5596 adverse events (AEs) were collected from 2164 valid reports: 50.6% female, 46.1% male, 3.3% unknown. Most reports were from Japan [(A) 57.8%; (B) 50.5%] and United States of America [(A) 23.0%; (B) 18.0%], followed by United Kingdom [(A) 5.6%] and Spain [(B) 11.6%]. The 3 most common AEs were the same in both groups: “dyskinesia” [(A) 22; 6.2% (B) 386; 6.9%;], “hallucination” [(A) 14; 4.0% (B) 179; 3.2%;] and “hallucination, visual” [(A) 14; 4.0% (B) 147; 2.6%;], all 3 considered expected. AE led to drug withdrawn in 38.1% of cases in group (A), and 32.7% of cases in group (B), with “dyskinesia” and “hallucination, visual” being the most common reason in both groups. Majority of events were non-serious: 250 (70.6%) in group A; 4562 (81.5%) in group (B).

Conclusion: Our analysis confirms a generally good safety profile in elderly patients, with no major differences in very elderly population. Most AEs were non-serious and the most reported were considered expected. This suggests that OPC maintains an adequate safety profile in real-world elderly patients.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/safety-profile-of-opicapone-in-elderly-and-very-elderly-population/