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Ropinirole 24-h Prolonged Release in Advanced Parkinson Disease: Review of a Randomized, Double-Blind, Placebo-Controlled Study (EASE PD - Adjunct Study)

Published online by Cambridge University Press:  22 October 2007

Kelly E. Lyons  and
Rajesh Pahwa
Kelly E. Lyons
Affiliation:
Department of Neurology, University of Kansas Medical Center, Kansas City, USA; Email: [email protected]
Rajesh Pahwa
Affiliation:
Department of Neurology, University of Kansas Medical Center, Kansas City, USA; Email: [email protected]
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ABSTRACT

This chapter reviews the EASE PD - Adjunct trial which is a double-blind, placebo-controlled, 24-week study of 393 Parkinson disease (PD) subjects with levodopa-induced motor fluctuations randomized to ropinirole 24-h prolonged release or placebo. The objective of the trial was to assess the efficacy and tolerability of once daily ropinirole 24-h prolonged release as an adjunct to levodopa. The primary outcome variable was the reduction in daily “off” time as measured by subject diaries which was significantly reduced by 2.1 h with ropinirole 24-h prolonged release (mean dosage: 18.8 mg/day) compared to 0.3 h with placebo. There were also significant improvements in daily “on” time, “on” time without troublesome dyskinesia, Unified Parkinson's Disease Rating Scale (UPDRS) motor and activities of daily living subscales, depression, quality of life and sleep with ropinirole 24-h prolonged release compared to placebo. The most common adverse events with ropinirole 24-h prolonged release were dyskinesia, nausea, dizziness, somnolence, hallucinations and orthostatic hypotension. Ropinirole 24-h prolonged release was well tolerated and led to improvements in both motor and non-motor symptoms of PD.

Keywords

motor complicationsParkinson diseaseropinirole prolonged release
Type
Research Article
Information
Progress in Neurotherapeutics and Neuropsychopharmacology , Volume 3 , Issue 1 , January 2008 , pp. 73 - 84
Copyright
© 2008 Cambridge University Press

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References

Baas, H., Beiske, A.G., Ghika, J., Jackson, M., Oertel, W.H., Poewe, W., et al. (1997). Catechol-O-methyltransferase inhibition with tolcapone reduces the “wearing off” phenomenon and levodopa requirements in fluctuating parkinsonian patients. Journal of Neurology Neurosurgery and Psychiatry, 63 (4), 421–428.Google Scholar
Beck, A.T., Ward, C.H., Mendelson, M., Mock, J., & Erbaugh, J. (1961). An inventory for measuring depression. Archives of General Psychiatry, 4, 561–571.Google Scholar
Chapuis, S., Ouchchane, L., Metz, O., Gerbaud, L., & Durif, F. (2005). Impact of the motor complications of Parkinson's disease on the quality of life. Movement Disorders, 20 (2), 224–230.Google Scholar
Chaudhuri, K.R., Pal, S., DiMarco, A., Whately-Smith, C., Bridgman, K., Mathew, R., et al. (2002). The Parkinson's disease sleep scale: a new instrument for assessing sleep and nocturnal disability in Parkinson's disease. Journal of Neurology Neurosurgery Psychiatry, 73 (6), 629–635.Google Scholar
Chaudhuri, K.R., Healy, D.G., & Schapira, A.H. (2006). Non-motor symptoms of Parkinson's disease: diagnosis and management. Lancet Neurology, 5 (3), 235–245.Google Scholar
Fahn, S., Elton, R.L., & Committee MotUD (1987). Unified Parkinson's disease rating scale. In: Fahn, S., Marsden, C.D., Calne, D.B., & Lieberman, A. (eds.), Recent Developments in Parkinson's Disease. Florham Park, New Jersey: Macmillan Health Care Information, pp. 153–163.
Golbe, L.I., Lieberman, A.N., Muenter, M.D., Ahlskog, J.E., Gopinathan, G., Neophytides, A.N., et al. (1988). Deprenyl in the treatment of symptom fluctuations in advanced Parkinson's disease. Clinical Neuropharmacology, 11 (1), 45–55.Google Scholar
Grosset, K.A., Bone, I., & Grosset, D.G. (2005). Suboptimal medication adherence in Parkinson's disease. Movement Disorders, 20 (11), 1502–1507.Google Scholar
Guttman, M. (1997). Double-blind comparison of pramipexole and bromocriptine treatment with placebo in advanced Parkinson's disease. International Pramipexole–Bromocriptine Study Group. Neurology, 49 (4), 1060–1065.Google Scholar
Hauser, R.A., Friedlander, J., Zesiewicz, T.A., Adler, C.H., Seeberger, L.C., O'Brien, C.F., et al. (2000). A home diary to assess functional status in patients with Parkinson's disease with motor fluctuations and dyskinesia. Clinical Neuropharmacology, 23 (2), 75–81.Google Scholar
Johns, M.W. (1991). A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep, 14 (6), 540–545.Google Scholar
Kieburtz, K., & Hubble, J. (2000). Benefits of COMT inhibitors in levodopa-treated parkinsonian patients: results of clinical trials. Neurology, 55 (11 Suppl. 4), S42–S45; discussion S46–S50.Google Scholar
Leopold, N.A., Polansky, M., & Hurka, M.R. (2004). Drug adherence in Parkinson's disease. Movement Disorders, 19 (5), 513–517.Google Scholar
LeWitt, P.A., Lyons, K.E., & Pahwa, R. (2007). Advanced Parkinson disease treated with rotigotine transdermal system: PREFER study. Neurology, 68 (16), 1262–1267.Google Scholar
Lieberman, A., Ranhosky, A., & Korts, D. (1997). Clinical evaluation of pramipexole in advanced Parkinson's disease: results of a double-blind, placebo-controlled, parallel-group study. Neurology, 49 (1), 162–168.Google Scholar
Lieberman, A., Olanow, C.W., Sethi, K., Swanson, P., Waters, C.H., Fahn, S., et al. (1998). A multicenter trial of ropinirole as adjunct treatment for Parkinson's disease. Ropinirole Study Group. Neurology, 51 (4), 1057–1062.Google Scholar
Miyasaki, J.M., Martin, W., Suchowersky, O., Weiner, W.J., & Lang, A.E. (2002). Practice parameter: initiation of treatment for Parkinson's disease: an evidence-based review: report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology, 58 (1), 11–17.Google Scholar
Miyasaki, J.M., Shannon, K., Voon, V., Ravina, B., Kleiner-Fisman, G., Anderson, K., et al. (2006). Practice parameter: evaluation and treatment of depression, psychosis, and dementia in Parkinson disease (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology, 66 (7), 996–1002.Google Scholar
Pahwa, R., Lyons, K.E., & Hauser, R.A. (2004). Ropinirole therapy for Parkinson's disease. Expert Reviews on Neurotherapy, 4 (4), 581–588.Google Scholar
Pahwa, R., Factor, S.A., Lyons, K.E., Ondo, W.G., Gronseth, G., Bronte-Stewart, H., et al. (2006). Practice parameter: treatment of Parkinson disease with motor fluctuations and dyskinesia (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology, 66 (7), 983–995.Google Scholar
Pahwa, R., Stacy, M.A., Factor, S.A., Lyons, K.E., Stocchi, F., Hersh, B.P., et al. (2007). Ropinirole 24-hour prolonged release: randomized, controlled study in advanced Parkinson disease. Neurology, 68 (14), 1108–1115.Google Scholar
Parkinson Study Group (1997). Entacapone improves motor fluctuations in levodopa-treated Parkinson's disease patients. Annals of Neurology, 42 (5), 747–755.Google Scholar
Parkinson Study Group (2005). A randomized placebo-controlled trial of rasagiline in levodopa-treated patients with Parkinson disease and motor fluctuations: the PRESTO study. Archives of Neurology, 62 (2), 241–248.Google Scholar
Peto, V., Jenkinson, C., & Fitzpatrick, R. (1998). PDQ-39: a review of the development, validation and application of a Parkinson's disease quality of life questionnaire and its associated measures. Journal of Neurology, 245 (Suppl. 1), S10–S14.Google Scholar
Rajput, A.H., Martin, W., Saint-Hilaire, M.H., Dorflinger, E., & Pedder, S. (1997). Tolcapone improves motor function in parkinsonian patients with the “wearing-off” phenomenon: a double-blind, placebo-controlled, multicenter trial. Neurology, 49 (4), 1066–1071.Google Scholar
Rascol, O., Lees, A.J., Senard, J.M., Pirtosek, Z., Montastruc, J.L., & Fuell, D. (1996). Ropinirole in the treatment of levodopa-induced motor fluctuations in patients with Parkinson's disease. Clinical Neuropharmacology, 19 (3), 234–245.Google Scholar
Rascol, O., Brooks, D.J., Melamed, E., Oertel, W., Poewe, W., Stocchi, F., et al. (2005). Rasagiline as an adjunct to levodopa in patients with Parkinson's disease and motor fluctuations (LARGO, lasting effect in adjunct therapy with rasagiline given once daily, study): a randomised, double-blind, parallel-group trial. Lancet, 365 (9463), 947–954.Google Scholar
Rinne, U.K., Larsen, J.P., Siden, A., & Worm-Petersen, J. (1998). Entacapone enhances the response to levodopa in parkinsonian patients with motor fluctuations. Nomecomt Study Group. Neurology, 51 (5), 1309–1314.Google Scholar
Waters, C.H., Sethi, K.D., Hauser, R.A., Molho, E., & Bertoni, J.M. (2004). Zydis selegiline reduces off time in Parkinson's disease patients with motor fluctuations: a 3-month, randomized, placebo-controlled study. Movement Disorders, 19 (4), 426–432.Google Scholar