Objective: This study aimed to investigate the risk of adverse events (AEs) when opicapone (OPC) was added as adjunctive therapy to L-dopa administration.

Background: Levodopa equivalent daily dose (LEDD) with OPC is calculated as 1.5 times higher the dose of L-dopa without OPC.

Method: We retrospectively collected data on AEs in 60 consecutive patients who were administered OPC from August 2021 to October 2022. Subsequently, we evaluated the relation between LEDD and the risk of AEs before OPC administration.

Results: Overall, 18 patients (30%) discontinued OPC: six (10%) were non-responders, two discontinued for social reasons, and ten (17%) discontinued for AEs [including hallucination/delusion in four (7%), orthostatic hypotension (OH) in four (7%), dyskinesia in three (5%), and somnolence in three (5%)]. The LEDD was significantly higher in the group that discontinued OPC due to hallucination/delusion (LEDD: 1125±318 mg) than in the group that continued OPC (LEDD: 813±277 mg) (p<0.05). The AEs of (1) hallucination/delusion or OH and (2) dyskinesia or somnolence were positively related to a higher LEDD [(1) 1046±283 mg and (2) 596±70 mg, p<0.05] but not with age [(1) 75±9 years and (2) 63±6 years, p=0.10]. [Discussion] Since the addition of OPC increased the LEDD by 1.5 times, the higher the L-dopa dose before OPC administration, the higher the increase in the LEDD and therefore the more likely the occurrence of AEs.

Conclusion: When OPC is administered to patients with a higher LEDD, particular attention should be paid to AEs, such as hallucination/delusion and OH.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/adverse-events-of-opicapone-adjunctive-therapy-in-60-consecutive-patients/