Efficacy of opicapone at different levodopa regimens up to a threshold of 600 mg/day levodopa in Parkinson's disease patients with motor fluctuations
Recommended Citation
Lewitt P, Stocchi F, Ferreira J, Klepitskaya O, Magalhães D, Rochae J, Soares-Da-Silvae P. Efficacy of opicapone at different levodopa regimens up to a threshold of 600 mg/day levodopa in Parkinson's disease patients with motor fluctuations. J Neurol Sci 2021; 429.
Document Type
Conference Proceeding
Publication Date
10-1-2021
Publication Title
J Neurol Sci
Keywords
levodopa, opicapone, placebo, adult, comparative effectiveness, conference abstract, controlled study, drug dose regimen, drug efficacy, drug therapy, female, human, major clinical study, male, Parkinson disease
Abstract
Background and aims: Opicapone (OPC) proved to be effective for end-of-dose motor fluctuations in Parkinson's disease (PD) patients. We evaluated the efficacy of OPC in PD patients with motor fluctuations being treated with different levodopa regimens up to a threshold of 600 mg/day levodopa. Methods: Efficacy data from BIPARK-I and II were combined for the placebo (PLC) and OPC-50 mg groups. Primary efficacy endpoint was change from baseline in OFF-time. Subgroup analyses were performed to evaluate the efficacy of OPC-50 mg in different levodopa regimens up to a threshold of 600 mg/day levodopa (300–400, 400–500 and 500–600 mg/day). Results: Full Analysis Set included 239 patients (PLC, n = 118; OPC-50 mg, n = 121). Mean OFF-time reduction was at least two-fold greater than PLC when OPC-50 mg was added to any levodopa regimen: mean (95% confidence interval) changes from baseline in absolute OFF-time for OPC-50 mg versus PLC were − 102.2 (−138.1, −66.3) versus −53.4 (−89.6, −17.3) min for patients treated with levodopa 300–400 mg/day, −110.0 (−146.7, −73.3) versus −37.2 (−77.7, 3.3) min for patients treated with levodopa 400–500 mg/day, and − 117.6 (−152.6, −82.6) versus −23.1 (−67.8, 21.6) min for patients treated with levodopa 500–600 mg/day. It was notable that, with increasing levodopa dose regimens, there was a trend towards decreasing magnitude of effect in the PLC group, compared with a trend towards a slight increase in magnitude of effect in the OPC-50 mg group (Fig. 1). Conclusions: OPC-50 mg showed at least a two-fold greater OFF-time reduction than placebo, with a slight increase in magnitude of effect with increasing levodopa regimens.
PubMed ID
Not assigned.
Volume
429
