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© 2007 American Academy of Neurology Ropinirole 24-hour prolonged releaseRandomized, controlled study in advanced Parkinson diseaseFrom the University of Kansas Medical Center (R.P., K.E.L.), Kansas City; Duke University Medical Center (M.A.S.), Durham, NC; Emory University School of Medicine (S.A.F.), Atlanta, GA; Institute of Neurology (F.S.), IRCCS San Raffaele Pisana, Rome, Italy; Harvard Vanguard Medical Associates and Harvard Medical School (B.P.H.), Boston, MA; University of Toledo College of Medicine (L.W.E.), OH; The Parkinson’s and Movement Disorder Institute (D.D.T.), Fountain Valley, CA; and GlaxoSmithKline (N.L.E.), Research Triangle Park, NC. Address correspondence and reprint requests to Dr. Rajesh Pahwa, Laverne and Joyce Rider Professor of Neurology, University of Kansas Medical Center, 3599 Rainbow Blvd, Mailstop 2012, Kansas City, KS 66160; e-mail: rpahwa{at}kumc.edu Objective: To evaluate the efficacy of ropinirole 24-hour prolonged release (ropinirole 24-hour) as an adjunct to levodopa in patients with Parkinson disease (PD) and motor fluctuations. Methods: In a double-blind, placebo-controlled, 24-week study, 393 subjects with PD were randomized to ropinirole 24-hour (n = 202) or placebo (n = 191). The primary outcome measure was reduction in hours of daily "off" time. Results: At week 24, the mean dose of ropinirole 24-hour was 18.8 mg/day with a mean reduction in daily levodopa of 278 mg. There was a mean reduction in daily "off" time of 2.1 hours in the ropinirole 24-hour group and 0.3 hours with placebo. Secondary outcome measures including change in hours and percent of daily "on" time and "on" time without troublesome dyskinesia, Unified PD Rating Scale motor and activities of daily living subscales, Beck Depression Inventory-II, PDQ-39 subscales of mobility, activities of daily living, emotional well-being, stigma and communication, and PD Sleep Scale were significantly improved at week 24 with ropinirole 24-hour. The most common adverse events (AE) with ropinirole 24-hour were dyskinesia, nausea, dizziness, somnolence, hallucinations, and orthostatic hypotension and AEs led to study withdrawal in 5% of both the active and placebo groups. Conclusion: Ropinirole 24-hour was effective and well tolerated as adjunct therapy in patients with Parkinson disease (PD) not optimally controlled with levodopa. Ropinirole 24-hour demonstrated an improvement in both motor and non-motor PD symptoms, while permitting a reduction in adjunctive levodopa dose.
*The principal EASE-PD Adjunct Study Investigators are listed in the appendix. Disclosures: This study was sponsored by GlaxoSmithKline (GSK) and Skye Pharma. R. Pahwa, S.A. Factor, K.E. Lyons, F. Stocchi, B.P. Hersh, L.W. Elmer, and D. Truong have received research grant support from GSK for research studies not reported in this article. This research support exceeded $10,000 for R. Pahwa, B.P. Hersh, and D. Truong. R. Pahwa, M.A. Stacy, S.A. Factor, K.E. Lyons, F. Stocchi, B.P. Hersh, and L.W. Elmer have received personal compensation from GSK. This compensation has exceeded $10,000/year for R. Pahwa, F. Stocchi, and B.P. Hersh. N.L. Earl is an employee of GSK. Received May 22, 2006. Accepted in final form December 5, 2006.
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