Session Time: 1:45pm-3:15pm
Location: Agora 3 West, Level 3
Objective: To evaluate the impact of motor fluctuations (MF) duration, levodopa dose and levodopa duration of use (LDU) in efficacy responses of levodopa-treated Parkinson’s Disease (PD) patients with MF.
Background: Opicapone (OPC), a once-daily COMT inhibitor, proved effective in the treatment of MF in PD in two large, pivotal, multinational trials (BIPARK-I and II) ,.
Method: Patient-level data from matching treatment arms in BIPARK-I and II were combined in placebo (PLC) and OPC-50mg groups. Studies had similar designs (primary efficacy endpoint: change from baseline in patient diaries-based absolute OFF-time) and eligibility criteria ,. This post-hoc analysis assessed influence of MF duration (years), levodopa dose (mg) and LDU (years) in efficacy outcomes (OFF-/ON-time change from baseline). Applied linear regression’s slope was statistically tested for deviation from zero.
Results: 1027 patients were randomized to BIPARK-I and II; Full Analysis Set comprised 517 [PLC (n=255); OPC-50mg (n=262)]. Due to lack of matched-patients, four OPC-50mg patients (MF >12 years) were excluded from MF analysis and two PLC (<1 year) and five OPC-50mg (>18 years) patients were excluded from LDU analysis. Mean baseline values were 2.4 (PLC) to 2.5 (OPC-50mg) years of MF, 696mg (PLC) to 698mg (OPC-50mg) of levodopa and 6.4 (PLC) to 6.0 (OPC-50mg) years of use. OFF-/ON-time magnitude of responses was not influenced by any parameter. Linear regression was non-significant for each arm and variables analyzed.
Conclusion: MF duration, levodopa dose and LDU do not appear to impact OFF-/ON-time magnitude of responses in a clinical study setting.
References:  Ferreira et al., Lancet Neurology 2016;15(2):154-165.  Lees et al., JAMA Neurol. 2017;74(2):197-206.
To cite this abstract in AMA style:A. Santos, A. Lees, J. Ferreira, O. Rascol, A. Antonini, F. Ikedo, D. Magalhães, J. Rocha, P. Soares-da-Silva. Influence of motor fluctuations duration, levodopa dose and duration of use in efficacy responses of Parkinson’s disease patients: post-hoc analysis from combined BIPARK-I and II. [abstract]. Mov Disord. 2019; 34 (suppl 2). https://www.mdsabstracts.org/abstract/influence-of-motor-fluctuations-duration-levodopa-dose-and-duration-of-use-in-efficacy-responses-of-parkinsons-disease-patients-post-hoc-analysis-from-combined-bipark-i-and-ii/. Accessed December 2, 2023.
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