Objective: To assess the efficacy of opicapone 50 mg (OPC 50 mg), compared with entacapone (ENT), in catechol-O-methyltransferase inhibitor (COMTi)-naïve Parkinson’s disease (PD) patients recently diagnosed with motor fluctuations (MF).
Background: OPC, a once-daily COMTi, was shown to be effective for end-of-dose MF in PD patients in two large multinational trials (BIPARK-I and II) [1, 2].
Method: OPC 50 mg and ENT data from COMTi-naïve patients in BIPARK-I [1] were analysed. Primary efficacy endpoint was change from baseline in OFF-time based on patient diaries. An Analysis of Covariance model was used for the Full Analysis Set (FAS; patients treated with >/=1 dose and with >/=1 post-baseline OFF-time assessment) using last observation carried forward. For labelling purposes, the European Medicines Agency requested a more conservative approach to diary-based outcomes, with all treated patients included in the FAS (FAS2) and baseline observation carried forward (BOCF) used for patients who discontinued having improved (currently reflected in the EU Summary of Product Characteristics). Recently diagnosed patients with MF were ‘recent fluctuators’, defined as those with an onset of MF </=1 year of study baseline. This post-hoc conservative analysis assessed the efficacy of OPC 50 mg versus ENT in the FAS2 using BOCF.
Results: Overall, 97 COMT-naïve patients who were recent fluctuators were randomised to OPC 50 mg (n=50) or ENT (n=47). Change from baseline to endpoint in absolute OFF-time was numerically greater for OPC 50 mg versus ENT (-55.8 mins, p=0.0633; Table 2). Change from baseline to endpoint in absolute ON-time was significantly greater for OPC 50 mg versus ENT (+64.0 mins p=0.0344; Table 2).
Conclusion: This post-hoc conservative analysis demonstrated that OPC 50 mg significantly increased absolute ON-time (by approximately 1 h), compared with ENT, when used as first adjunctive COMTi in levodopa-treated PD patients recently diagnosed with MF.
References: 1. Ferreira JJ, et al. Lancet Neurol. 2016;15:154–65. 2. Lees AJ, et al. JAMA Neurol. 2017;74:197–206.
To cite this abstract in AMA style:
J. Ferreira, A. Lees, G. Ebersbach, A.T Santos, D. Magalhães, J.F Rocha, P. Soares-da-Silva. Efficacy of opicapone compared to entacapone in catechol-O-methyltransferase inhibitor-naïve Parkinson’s disease patients recently diagnosed with motor fluctuations: A post-hoc conservative analysis [abstract]. Mov Disord. 2020; 35 (suppl 1). https://www.mdsabstracts.org/abstract/efficacy-of-opicapone-compared-to-entacapone-in-catechol-o-methyltransferase-inhibitor-naive-parkinsons-disease-patients-recently-diagnosed-with-motor-fluctuations-a-post-hoc-conservative-an/. Accessed June 15, 2025.« Back to MDS Virtual Congress 2020
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