Are Branded and Generic Extended-Release Ropinirole Formulations Equally Efficacious? A Rater-Blinded, Switch-Over, Multicenter Study
Joint Authors
Bosnyák, Edit
Herceg, Mihály
Pál, Endre
Aschermann, Zsuzsanna
Janszky, József
Késmárki, Ildikó
Komoly, Sámuel
Karádi, Kázmér
Dóczi, Tamás
Nagy, Ferenc
Kovács, Norbert
Source
Issue
Vol. 2014, Issue 2014 (31 Dec. 2014), pp.1-7, 7 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2014-08-26
Country of Publication
Egypt
No. of Pages
7
Main Subjects
Abstract EN
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.
American Psychological Association (APA)
Bosnyák, Edit& Herceg, Mihály& Pál, Endre& Aschermann, Zsuzsanna& Janszky, József& Késmárki, Ildikó…[et al.]. 2014. Are Branded and Generic Extended-Release Ropinirole Formulations Equally Efficacious? A Rater-Blinded, Switch-Over, Multicenter Study. Parkinson’s Disease،Vol. 2014, no. 2014, pp.1-7.
https://search.emarefa.net/detail/BIM-1047199
Modern Language Association (MLA)
Bosnyák, Edit…[et al.]. Are Branded and Generic Extended-Release Ropinirole Formulations Equally Efficacious? A Rater-Blinded, Switch-Over, Multicenter Study. Parkinson’s Disease No. 2014 (2014), pp.1-7.
https://search.emarefa.net/detail/BIM-1047199
American Medical Association (AMA)
Bosnyák, Edit& Herceg, Mihály& Pál, Endre& Aschermann, Zsuzsanna& Janszky, József& Késmárki, Ildikó…[et al.]. Are Branded and Generic Extended-Release Ropinirole Formulations Equally Efficacious? A Rater-Blinded, Switch-Over, Multicenter Study. Parkinson’s Disease. 2014. Vol. 2014, no. 2014, pp.1-7.
https://search.emarefa.net/detail/BIM-1047199
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1047199