Clinical parkinsonism & related disorders
Safety of opicapone in the elderly and very elderly population: an analysis of reported events in a global safety database
By Hatano T, LeWitt PA, Maeda T and 6 others.
Abstract
Introduction
Older people with Parkinson's disease (PD) are under-represented in clinical trials despite increasing disease burden and complexity. Although opicapone is approved as an adjunct to levodopa, data in elderly populations are limited. This study assessed its real-world safety in the elderly using post-marketing pharmacovigilance data.
Methods
This retrospective analysis used the global opicapone safety database (data-lock: 31 Jan 2026). Valid case safety reports with opicapone as the suspected product were included and classified as elderly (≥65-84 years) or very elderly (≥85 years). Adverse events were analyzed descriptively by system organ class, preferred term, and seriousness. Non-standard use and treatment actions were also assessed.