A Long-Term Study of Istradefylline Safety and Efficacy in Patients With Parkinson Disease. Issue 2 (March 2015)

• Record Type: Journal Article
• Authors: Kondo, Tomoyoshi; Mizuno, Yoshikuni
• Is Part Of: Clinical neuropharmacology. Volume 38:Issue 2(2015)
• Publication Date: 2015-03
• Subjects: Neuropharmacology -- Periodicals; 615.78
• DOI: 10.1097/WNF.0000000000000073
• Languages: English
• ISSNs: 0362-5664

Abstract

<abstract> <title> <x xml:space="preserve">Abstract</x> </title> <sec> <title>Objectives</title> <p>Istradefylline is a selective adenosine A<sub>2A</sub> receptor antagonist. We evaluated the safety and efficacy of istradefylline administered once daily for 52 weeks in Parkinson disease (PD) patients experiencing wearing-off symptoms on levodopa therapy.</p> </sec> <sec> <title>Methods</title> <p>This was a phase 3, multicenter, open-label, long-term study in PD patients experiencing wearing-off who had previously completed a double-blind placebo-controlled clinical study of istradefylline in Japan. Istradefylline was administered for 52 weeks at a starting dosage of 20 mg/d, with or without dosage adjustment up to 40 mg/d. Safety was assessed using the incidence of treatment-emergent adverse events, and efficacy was assessed as the change in the daily off time.</p> </sec> <sec> <title>Results</title> <p>A total of 308 patients were included in this study. The most frequently reported treatment-emergent adverse events were nasopharyngitis (24.4%) and dyskinesia (21.4%). The mean change in the daily off time from day 1 was −0.65 hour in week 2, fluctuating between −0.71 and −0.04 hour until week 52 in patients who had previously taken placebo in the preceding double-blind study. The off time reduction from baseline of the double-blind study remained at similar levels between weeks 2 and 52 in patients who had previously taken istradefylline 20 and 40 mg/d in the preceding double-blind study.</p> </sec> <sec> <title>Conclusions</title> <p>This study showed that istradefylline treatment was well tolerated and produced a sustained reduction in off time in levodopa-treated PD patients over a 52-week period.</p> </sec> </abstract>