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Abstracts from the International Congress of Parkinson’s and Movement Disorders.

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Efficacy of Istradefylline, an A2A Receptor Antagonist, When Added to Levodopa (LD) and Other Medications for Parkinson’s Disease (PD)

P. Lewitt, N. Hattori, A. Mori, K. Toyama, E. Ohta, P. Salzman, S. Isaacson (West Bloomfield, MI, USA)

Meeting: 2019 International Congress

Abstract Number: 137

Keywords: Adenosine antagonists, Levodopa(L-dopa), Wearing-off fluctuations

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 clinical effect of istradefylline as adjunctive treatment to LD in PD patients with or without additional PD medications (meds).

Background: Istradefylline, a selective adenosine A2A receptor antagonist, acts in the indirect striatal outflow pathway. While monotherapy studies have not shown benefit, 20 and 40 mg/day doses were shown to decrease OFF-time when used adjunctively with LD in PD patients experiencing wearing-off.

Method: Istradefylline was evaluated in 12-wk double-blind, placebo-controlled randomized clinical studies. PD patients receiving LD and experiencing wearing-off received istradefylline or placebo. Other anti-PD meds could be continued at unchanged doses. Change from baseline in daily OFF-time was assessed using patient-completed 24-hr ON/OFF diaries. Adverse events (AEs) were recorded throughout the study. A pooled post-hoc analysis of 5 independent clinical trials assessed the reduction in OFF-time with istradefylline vs placebo when patients were divided into 2 subgroups: those receiving only LD and those receiving LD+other anti-PD meds. Data from 20 or 40 mg istradefylline dose groups were combined. Pooled analyses used a mixed-model repeated-measures approach.

Results: Following randomization, baseline clinical and demographic characteristics were similar across treatment groups (placebo, 20 or 40 mg istradefylline). Between subgroups, patients receiving LD+anti-PD meds vs treatment with LD only had lower mean daily LD doses (766 and 579 mg, respectively) and longer mean durations since: PD diagnosis (7.4 and 8.9 yrs), starting LD (7.2 and 8.2 yrs), and onset of motor complications (2.8 and 3.8 yrs). Baseline OFF-time was similar across treatments and subgroups (~6 hrs/day). In both subgroups, OFF-time was reduced from baseline with istradefylline treatment, and was significantly greater than for patients receiving placebo (Table). Overall, istradefylline was well-tolerated; dyskinesia was the most frequent reported AE. [table1]

Conclusion: Istradefylline has unique pharmacologic properties distinct from other currently-approved meds for PD. This post-hoc analysis demonstrates that, as compared with placebo, istradefylline as an adjunct to LD and other anti-PD meds reduced OFF-time from baseline beyond the effects of concomitant meds for PD. Sponsor of studies: Kyowa Hakko Kirin Co., Ltd.

Table

To cite this abstract in AMA style:

P. Lewitt, N. Hattori, A. Mori, K. Toyama, E. Ohta, P. Salzman, S. Isaacson. Efficacy of Istradefylline, an A2A Receptor Antagonist, When Added to Levodopa (LD) and Other Medications for Parkinson’s Disease (PD) [abstract]. Mov Disord. 2019; 34 (suppl 2). https://www.mdsabstracts.org/abstract/efficacy-of-istradefylline-an-a2a-receptor-antagonist-when-added-to-levodopa-ld-and-other-medications-for-parkinsons-disease-pd/. Accessed May 21, 2025.
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