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- Brief communication Safety and efficacy of istradefylline in Parkinson’s disease patients with and without pre-existing dyskinesia: Pooled analysis of 8 randomized controlled trials
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Nobutaka Hattori1
, Lawrence Elmer2, Stuart H. Isaacson3, Rajesh Pahwa4, Olivier Rascol5, Kapil Sethi6, Fabrizio Stocchi7, Yu Nakajima8, Hannah Cummings9, Lia Kostiuk9 -
DOI: https://doi.org/10.14802/jmd.25047 [Accepted]
Published online: April 25, 2025
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1Department of Neurology, Juntendo University School of Medicine, Tokyo, Japan
2Department of Neurology, College of Medicine and Life Sciences, University of Toledo, Toledo, OH, USA
3Parkinson’s Disease and Movement Disorders Center of Boca Raton, Boca Raton, FL, USA
4University of Kansas Medical Center, Kansas City, KS, USA
5Toulouse Parkinson Expert Center, Departments of Neurosciences and Clinical Pharmacology, Centre d'Investigation Clinique de Toulouse CIC1436, NS-Park/FCRIN Network, and NeuroToul COEN Center, University Hospital of Toulouse, INSERM, University of Toulous
6Medical College of Georgia, Augusta University, Augusta, GA, USA
7Department of Neurology, IRCCS San Raffaele Pisana, Rome, Italy
8Biometrics, Kyowa Kirin Co., Ltd., Tokyo, Japan
9Medical Affairs, Kyowa Kirin, Inc., Bedminster, NJ, USA
2Department of Neurology, College of Medicine and Life Sciences, University of Toledo, Toledo, OH, USA
3Parkinson’s Disease and Movement Disorders Center of Boca Raton, Boca Raton, FL, USA
4University of Kansas Medical Center, Kansas City, KS, USA
5Toulouse Parkinson Expert Center, Departments of Neurosciences and Clinical Pharmacology, Centre d'Investigation Clinique de Toulouse CIC1436, NS-Park/FCRIN Network, and NeuroToul COEN Center, University Hospital of Toulouse, INSERM, University of Toulous
6Medical College of Georgia, Augusta University, Augusta, GA, USA
7Department of Neurology, IRCCS San Raffaele Pisana, Rome, Italy
8Biometrics, Kyowa Kirin Co., Ltd., Tokyo, Japan
9Medical Affairs, Kyowa Kirin, Inc., Bedminster, NJ, USA
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Corresponding author:
Nobutaka Hattori, Tel: +81-3-5802-1017, Fax: +81-3-5800-0428,
Email: nhattori@juntendo.ac.jp
Received: 27 February 2025 • Revised: 8 April 2025 • Accepted: 25 April 2025
Abstract
Objectives
Evaluate the efficacy of istradefylline in people with Parkinson’s disease with motor fluctuations, with and without dyskinesia, and characterize potential predictors for treatment-emergent dyskinesia with istradefylline.
Methods
Pooled analysis of 8 phase 2b/3 trials of istradefylline (20 or 40mg/day) versus placebo.
Results
Data from 2719 patients, including 56% with baseline dyskinesia, were analyzed post-hoc. The presence of baseline dyskinesia did not affect mean reductions in OFF-time, increases in ON-time without troublesome dyskinesia, or improvements in Unified Parkinson’s Disease Rating Scale motor scores associated with istradefylline treatment. Dyskinesia was reported by 17% of istradefylline-treated patients, with higher rates for women (21%), patients with BMI <18.5 kg/m2 (22%), and patients treated with COMT inhibitors plus dopamine agonists (22%) and MAO-B inhibitors (25%).
Conclusion
Istradefylline treatment resulted in greater reductions in total OFF hours/day and increases in ON-time without troublesome dyskinesia versus placebo regardless of the presence or absence of pre-existing dyskinesia.
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