Objective: This exploratory post-hoc analysis evaluated the efficacy and safety of opicapone (OPC) in levodopa-treated Parkinson’s disease (PD) patients with duration of motor fluctuations of up to 1 year (‘early motor fluctuators’ [EMF]) or more than 1 year (‘long-standing MF’ [LMF]).

Background:
OPC, a once-daily catechol-O-methyltransferase inhibitor, proved effective in the treatment of end-of-dose motor fluctuations in PD patients in two large multinational trials (BIPARK-I and II) [1,2].

Method:
Patient-level data from matching treatment arms in BIPARK-I and II were combined in placebo (PLC) and OPC 50 mg groups. Studies had similar designs and eligibility criteria [1,2]. Outcomes were compared for PLC versus OPC for EMF and LMF. Statistical analysis of efficacy was performed using Analysis of Covariance.

Results:
Overall, 71 PLC and 85 OPC patients were EMF whereas 174 PLC and 162 OPC patients were LMF (Safety Set; Table 1). Changes from baseline in absolute OFF- and ON-time were significantly greater for OPC versus PLC in both EMF and LMF (Table 2). Dyskinesia was the most frequently reported at least possibly related treatment-emergent adverse event, with approximately two-fold increase in incidence in LMF versus EMF in the OPC groups (23.5% vs. 11.8%), which might be due to longer disease duration and higher daily levodopa dose.

Conclusion:
OPC 50 mg demonstrated efficacy in both EMF and LMF, with a lower incidence of dyskinesia in EMF. This reinforces the usage of OPC regardless of duration of motor fluctuations.

References: 1. Ferreira et al., Lancet Neurol. 2016;15(2):154-165. 2. Lees et al., JAMA Neurol. 2017;74(2):197-206.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/efficacy-and-safety-of-opicapone-in-parkinsons-disease-patients-according-to-duration-of-motor-fluctuations-post-hoc-analysis-of-bipark-i-and-ii/