Incidence of adverse and safety events in individuals with Parkinson’s disease treated with catechol-o-methyltransferase inhibitor opicapone as an add-on to levodopa treatment: a systematic review and meta-analysis

Paula Abola; George Jabishvili

doi:10.56782/pps.563

Published : 2025-08-13

Vol. 23 No. 4 (2025)

Incidence of adverse and safety events in individuals with Parkinson’s disease treated with catechol-o-methyltransferase inhibitor opicapone as an add-on to levodopa treatment: a systematic review and meta-analysis

Paula Abola

George Jabishvili

DOI: https://doi.org/10.56782/pps.563

Abstract

Opicapone, a once-daily catechol-O-methyltransferase (COMT) inhibitor, is used as an add-on to levodopa treatment to manage motor fluctuations in Parkinson’s disease (PD). Although its efficacy in extending ON time is established, the safety profile of opicapone, particularly regarding adverse events and dyskinesia, remains under investigation. A systematic review and meta-analysis were performed on randomized controlled trials (RCTs) and open-label trials that investigated the incidence of adverse events in individuals with PD treated with opicapone as an add-on to levodopa treatment. The systematic search was conducted in PubMed, Cochrane, and EBSCO Megafile databases. Random-effects meta-analyses calculated risk ratios (RR) for adverse events, serious adverse events, adverse events leading to discontinuation, and dyskinesia. Certainty of evidence was assessed using the Cochrane Grading of Recommendations Assessment, Development and Evaluation approach. Six studies (n = 2705) were included, with four RCTs eligible for meta-analysis. Opicapone at both 25 mg and 50 mg doses was associated with a significantly increased risk of dyskinesia compared to placebo (25 mg: RR = 2.47; 50 mg: RR = 2.75). No statistically significant differences were found for overall adverse events, serious adverse events, or adverse events leading to discontinuation. Heterogeneity across studies was generally low. Opicapone, as an add-on to levodopa treatment, shows a favorable overall safety profile, with the primary concern being an increased incidence of dyskinesia. Clinicians should monitor for motor complications and adjust levodopa dosing as needed. Further research is needed to refine dyskinesia management strategies and evaluate long-term safety outcomes.

Keywords:

Parkinson’s Disease, Opicapone, adverse events, safety events

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Abola, P., & Jabishvili, G. (2025). Incidence of adverse and safety events in individuals with Parkinson’s disease treated with catechol-o-methyltransferase inhibitor opicapone as an add-on to levodopa treatment: a systematic review and meta-analysis. Prospects in Pharmaceutical Sciences, 23(4), 175–185. https://doi.org/10.56782/pps.563

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Paula Abola

paula.abola@uj.edu

Affiliation:

a:1:{s:5:"en_US";s:23:"University of Jamestown";} United States

George Jabishvili

Affiliation:

FIECON United Kingdom