Session Information
Date: Monday, September 23, 2019
Session Title: Clinical Trials, Pharmacology and Treatment
Session Time: 1:45pm-3:15pm
Location: Agora 3 West, Level 3
Objective: To evaluate the incidence of treatment-emergent adverse events (TEAEs) in levodopa-treated Parkinson’s Disease (PD) patients with motor fluctuations and taking opicapone (OPC).
Background: OPC is a once-daily COMT inhibitor that proved effective in the treatment of motor fluctuations in PD patients in two large, pivotal, 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-50mg groups. The studies had similar designs (primary efficacy endpoint: change from baseline in patient diaries-based absolute OFF-time) and eligibility criteria [1],[2]. Safety was assessed by incidence of TEAEs, laboratory parameters, ECGs and vital signs. An exploratory post-hoc analysis was performed to evaluate the incidence of TEAEs according to baseline body mass index (BMI).
Results: Of the 1027 patients randomized to BIPARK-I and II, 522 patients took a dose of study medication (OPC-50mg n=265, PLC n=257) and were included in this analysis. 18-30 kg/m2 BMI patients represented ~78% of both OPC-50mg and PLC groups. Overall, 64.2% of OPC-50mg patients reported any TEAE compared to 57.2% in PLC. There was a comparable-to-overall incidence of TEAEs for 18-30 kg/m2 BMI-matched patients (65.9% vs. 55.5% for OPC-50mg and PLC groups). In contrast, for >30 kg/m2 BMI-matched patients, TEAEs’ incidence was lower in OPC-treated patients (54.5%) than PLC-treated ones (63.0%). The most frequently occurring TEAE was dyskinesia in both subgroups.
Conclusion: Opicapone appears to be well-tolerated in both 18-30 kg/m2 and >30 kg/m2 BMI patients.
References: [1] Ferreira et al., Lancet Neurology 2016; 15(2):154-165. [2] Lees et al., JAMA Neurol. 2017; 74(2):197-206.
To cite this abstract in AMA style:
F. Ikedo, J. Ferreira, A. Lees, E. Tolosa, W. Poewe, R. Costa, D. Magalhães, J. Rocha, P. Soares-da-Silva. Incidence of treatment-emergent adverse events in Parkinson’s disease patients according to baseline body mass index: post-hoc analysis from double-blind combined BIPARK-I and II data. [abstract]. Mov Disord. 2019; 34 (suppl 2). https://www.mdsabstracts.org/abstract/incidence-of-treatment-emergent-adverse-events-in-parkinsons-disease-patients-according-to-baseline-body-mass-index-post-hoc-analysis-from-double-blind-combined-bipark-i-and-ii-data/. Accessed June 15, 2025.« Back to 2019 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/incidence-of-treatment-emergent-adverse-events-in-parkinsons-disease-patients-according-to-baseline-body-mass-index-post-hoc-analysis-from-double-blind-combined-bipark-i-and-ii-data/