Objective: To evaluate the efficacy of opicapone (OPC) in Parkinson’s disease (PD) patients with motor fluctuation (MF) according to levodopa’s duration of use.

Background: OPC proved to be effective in treating end-of-dose MF in PD patients [1,2].

Method: Matching OPC 50 mg and placebo (PLC) data from BIPARK-I and II [1, 2] were combined. The studies had similar designs, eligibility criteria and methodologies. Primary efficacy endpoint was change from baseline in absolute OFF-time. Safety was assessed by evaluating the incidence of treatment-emergent adverse events (TEAEs). Subgroup analyses were performed to evaluate consistency and potential trends between subgroups based on levodopa’s duration of use at baseline (Table 1). Efficacy subgroup analyses were performed using Analysis of Covariance. Safety assessments were analysed descriptively.

Results: Overall, 522 patients were randomised to PLC (n=257) and OPC 50 mg (n=265) (Table 1). OPC 50 mg was significantly more effective than PLC for all subgroup analyses (p<0.05), except for the subgroup of patients treated with levodopa for ≥7 years and ≥8 years (Table 2). Moreover, OPC 50 mg demonstrated enhanced efficacy in patients who were lower in each subgroup threshold (Table 2). There was also a trend towards a lower incidence of dopaminergic-related TEAEs in the same subgroups of patients (Table 3).

Conclusion: These findings indicate that there may be an added benefit from using OPC 50 mg as a first-line adjunctive therapy to levodopa and promptly in the motor fluctuations spectrum of PD.

References: 1. Ferreira JJ, et al. Lancet Neurol. 2016;15:154–65. 2. Lees AJ, et al. JAMA Neurol. 2017;74:197–206.

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