Clinical parkinsonism & related disorders · 2026
Safety of opicapone in the elderly and very elderly population: an analysis of reported events in a global safety database.
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Hatano Taku, LeWitt Peter A, Maeda Tetsuya, Mora Javier Pagonabarraga, Dias Bruno F, Brigas Helena C, Lopes Diogo, Gama Helena, Holenz Joerg
Аннотация
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.
RESULTS: Among 2914 analyzed cases (2558 elderly; 356 very elderly), 7195 adverse events were reported. Most reported events were non-serious (81.4% of events in elderly cases; 73.5% in very elderly cases). Dyskinesia was the most frequently reported event in both groups (7.1%-7.7% of events), followed by hallucination and visual hallucination (all <5% of events). Serious events accounted for a greater proportion of reported events in the very elderly versus elderly group (26.5% vs 18.6%), although no individual preferred term exceeded 5%. Non-standard use accounted for 6.0% and 3.5% of reported events in the very elderly and elderly groups, respectively, and included altered administration and off-label indications. Treatment was discontinued in approximately half of cases in both groups.
CONCLUSION: Reported adverse event patterns were generally consistent with the established safety profile of opicapone across both age groups. No unexpected reporting patterns were observed; however, findings should be interpreted within the limitations of spontaneous 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.
RESULTS: Among 2914 analyzed cases (2558 elderly; 356 very elderly), 7195 adverse events were reported. Most reported events were non-serious (81.4% of events in elderly cases; 73.5% in very elderly cases). Dyskinesia was the most frequently reported event in both groups (7.1%-7.7% of events), followed by hallucination and visual hallucination (all <5% of events). Serious events accounted for a greater proportion of reported events in the very elderly versus elderly group (26.5% vs 18.6%), although no individual preferred term exceeded 5%. Non-standard use accounted for 6.0% and 3.5% of reported events in the very elderly and elderly groups, respectively, and included altered administration and off-label indications. Treatment was discontinued in approximately half of cases in both groups.
CONCLUSION: Reported adverse event patterns were generally consistent with the established safety profile of opicapone across both age groups. No unexpected reporting patterns were observed; however, findings should be interpreted within the limitations of spontaneous pharmacovigilance data.