title: Are branded and generic extended-release ropinirole formulations equally efficacious? A rater-blinded, switch-over, multicenter study.
abstract: The aim of this study was to compare the efficacy of the branded and a generic extended-release ropinirole formulation in the treatment of advanced Parkinson's disease (PD). Of 22 enrolled patients 21 completed the study. A rater blinded to treatment evaluated Unified Parkinson's Disease Rating Scale, Fahn-Tolosa-Marin Tremor Rating Scale, Nonmotor Symptoms Assessment Scale, and a structured questionnaire on ropinirole side effects. Besides, the patients self-administered EQ-5D, Parkinson's Disease Sleep Scale (PDSS-2), and Beck Depression Inventories. Branded and generic ropinirole treatment achieved similar scores on all tests measuring severity of motor symptoms (primary endpoint, UPDRS-III: 27.0 versus 28.0 points, P = 0.505). Based on patient diaries, the lengths of "good time periods" were comparable (10.5 and 10.0 hours for branded and generic ropinirole, resp., P = 0.670). However, generic ropinirole therapy achieved almost 3.0 hours shorter on time without dyskinesia (6.5 versus. 9.5 hours, P < 0.05) and 2.5 hours longer on time with slight dyskinesia (3.5 versus. 1.0 hours, P < 0.05) than the branded ropinirole did. Except for gastrointestinal problems, nonmotor symptoms were similarly controlled. Patients did not prefer either formulation. Although this study has to be interpreted with limitations, it demonstrated that both generic and branded ropinirole administration can achieve similar control on most symptoms of PD.
authors.affiliation: Department of Neurology, University of Pécs, Rét Utca 2, Pécs 7623, Hungary.
authors.forename: Edit
authors.initials: E
authors.lastname: Bosnyák
authors.affiliation: Department of Neurology, Kaposi Mór County Hospital, Tallián Gyula Utca 20-32, Kaposvár 7400, Hungary.
authors.forename: Mihály
authors.initials: M
authors.lastname: Herceg
authors.affiliation: Department of Neurology, University of Pécs, Rét Utca 2, Pécs 7623, Hungary.
authors.forename: Endre
authors.initials: E
authors.lastname: Pál
authors.affiliation: Department of Neurology, University of Pécs, Rét Utca 2, Pécs 7623, Hungary.
authors.forename: Zsuzsanna
authors.initials: Z
authors.lastname: Aschermann
authors.affiliation: Department of Neurology, University of Pécs, Rét Utca 2, Pécs 7623, Hungary ; MTA-PTE Clinical Neuroscience MR Research Group, Rét Utca 2, Pécs 7623, Hungary.
authors.forename: József
authors.initials: J
authors.lastname: Janszky
authors.affiliation: Department of Neurology, Health Center of City of Pécs, Dr. Veress Endre Utca 2, Pécs 7633, Hungary.
authors.forename: Ildikó
authors.initials: I
authors.lastname: Késmárki
authors.affiliation: Department of Neurology, University of Pécs, Rét Utca 2, Pécs 7623, Hungary.
authors.forename: Sámuel
authors.initials: S
authors.lastname: Komoly
authors.affiliation: Department of Neurology, University of Pécs, Rét Utca 2, Pécs 7623, Hungary ; Institute of Behavioral Sciences, University of Pécs, Szigeti Utca 12, Pécs 7624, Hungary.
authors.forename: Kázmér
authors.initials: K
authors.lastname: Karádi
authors.affiliation: MTA-PTE Clinical Neuroscience MR Research Group, Rét Utca 2, Pécs 7623, Hungary ; Department of Neurosurgery, University of Pécs, Rét Utca 2, Pécs 7623, Hungary.
authors.forename: Tamás
authors.initials: T
authors.lastname: Dóczi
authors.affiliation: Department of Neurology, Kaposi Mór County Hospital, Tallián Gyula Utca 20-32, Kaposvár 7400, Hungary.
authors.forename: Ferenc
authors.initials: F
authors.lastname: Nagy
authors.affiliation: Department of Neurology, University of Pécs, Rét Utca 2, Pécs 7623, Hungary ; MTA-PTE Clinical Neuroscience MR Research Group, Rét Utca 2, Pécs 7623, Hungary.
authors.forename: Norbert
authors.identifier: 0000-0002-7332-9240
authors.initials: N
authors.lastname: Kovács