Effects of long-term treatment with rotigotine transdermal system on dyskinesia in patients with early-stage Parkinson's disease.
Identifieur interne : 000036 ( PubMed/Checkpoint ); précédent : 000035; suivant : 000037Effects of long-term treatment with rotigotine transdermal system on dyskinesia in patients with early-stage Parkinson's disease.
Auteurs : Nir Giladi [Israël] ; Liesbet Ghys [Belgique] ; Erwin Surmann [Allemagne] ; Babak Boroojerdi [États-Unis] ; Joseph Jankovic [États-Unis]Source :
- Parkinsonism & related disorders ; 2014.
English descriptors
- KwdEn :
- Administration, Cutaneous, Adult, Age Factors, Aged, Aged, 80 and over, Antiparkinson Agents (administration & dosage), Disability Evaluation, Dose-Response Relationship, Drug, Double-Blind Method, Dyskinesias (diagnosis), Dyskinesias (epidemiology), Dyskinesias (etiology), Female, Humans, Kaplan-Meier Estimate, Levodopa (therapeutic use), Longitudinal Studies, Male, Middle Aged, Parkinson Disease (drug therapy), Sex Factors, Tetrahydronaphthalenes (administration & dosage), Thiophenes (administration & dosage).
- MESH :
- chemical , administration & dosage : Antiparkinson Agents, Tetrahydronaphthalenes, Thiophenes.
- diagnosis : Dyskinesias.
- drug therapy : Parkinson Disease.
- epidemiology : Dyskinesias.
- etiology : Dyskinesias.
- chemical , therapeutic use : Levodopa.
- Administration, Cutaneous, Adult, Age Factors, Aged, Aged, 80 and over, Disability Evaluation, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Kaplan-Meier Estimate, Longitudinal Studies, Male, Middle Aged, Sex Factors.
Abstract
In two 6-month, double-blind, placebo-controlled studies, rotigotine transdermal system was well-tolerated and efficacious monotherapy in early-stage PD. This post hoc analysis of the long-term open-label extensions (NCT00594165; NCT00599196) of these studies assessed incidence and severity of dyskinesia in participants treated with rotigotine, with or without concomitant levodopa, for up to 6 years.
DOI: 10.1016/j.parkreldis.2014.09.016
PubMed: 25444083
Affiliations:
- Allemagne, Belgique, Israël, États-Unis
- Caroline du Nord, Région de Bruxelles-Capitale, Texas
- Bruxelles, Houston
- Baylor College of Medicine
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pubmed:25444083Le document en format XML
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<term>Aged, 80 and over</term>
<term>Antiparkinson Agents (administration & dosage)</term>
<term>Disability Evaluation</term>
<term>Dose-Response Relationship, Drug</term>
<term>Double-Blind Method</term>
<term>Dyskinesias (diagnosis)</term>
<term>Dyskinesias (epidemiology)</term>
<term>Dyskinesias (etiology)</term>
<term>Female</term>
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<term>Kaplan-Meier Estimate</term>
<term>Levodopa (therapeutic use)</term>
<term>Longitudinal Studies</term>
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<term>Middle Aged</term>
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<term>Sex Factors</term>
<term>Tetrahydronaphthalenes (administration & dosage)</term>
<term>Thiophenes (administration & dosage)</term>
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<front><div type="abstract" xml:lang="en">In two 6-month, double-blind, placebo-controlled studies, rotigotine transdermal system was well-tolerated and efficacious monotherapy in early-stage PD. This post hoc analysis of the long-term open-label extensions (NCT00594165; NCT00599196) of these studies assessed incidence and severity of dyskinesia in participants treated with rotigotine, with or without concomitant levodopa, for up to 6 years.</div>
</front>
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<Month>12</Month>
<Day>02</Day>
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<Month>08</Month>
<Day>19</Day>
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<Month>Dec</Month>
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<Title>Parkinsonism & related disorders</Title>
<ISOAbbreviation>Parkinsonism Relat. Disord.</ISOAbbreviation>
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<ArticleTitle>Effects of long-term treatment with rotigotine transdermal system on dyskinesia in patients with early-stage Parkinson's disease.</ArticleTitle>
<Pagination><MedlinePgn>1345-51</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.parkreldis.2014.09.016</ELocationID>
<ELocationID EIdType="pii" ValidYN="Y">S1353-8020(14)00338-1</ELocationID>
<Abstract><AbstractText Label="PURPOSE" NlmCategory="OBJECTIVE">In two 6-month, double-blind, placebo-controlled studies, rotigotine transdermal system was well-tolerated and efficacious monotherapy in early-stage PD. This post hoc analysis of the long-term open-label extensions (NCT00594165; NCT00599196) of these studies assessed incidence and severity of dyskinesia in participants treated with rotigotine, with or without concomitant levodopa, for up to 6 years.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">Open-label rotigotine was titrated to optimal dose (≤16 mg/24 h). Concomitant levodopa was permitted. Dyskinesia data, recorded using the Unified Parkinson's Disease Rating Scale Part IV, were pooled from the two open-label studies.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">Of 596 participants who received open-label rotigotine, 299 (50%) remained at trial closure; no patient discontinued due to dyskinesia. In the two studies, median exposure to rotigotine was 1910 days (∼5 years, 3 months), and 1564.5 days (∼4 years, 3 months). During up to 6 years of open-label rotigotine, 423/596 (71%) received levodopa. Dyskinesias were reported in 115/596 (19%) participants, 90/115 (78%) of who developed dyskinesia after levodopa was added; 25 reported dyskinesia in the absence of levodopa (includes patients who never received open-label levodopa, and those who reported dyskinesia before starting concomitant levodopa). Dyskinesia severity data were available for 107 of the 115 participants. In 56/107 (52%) participants, dyskinesia was considered 'not disabling' for all occurrences; the worst-case severity was 'mildly disabling' for 33/107 (31%), and 'moderately' or 'severely disabling' for 18/107 (17%; 3% of total participants).</AbstractText>
<AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">During treatment with rotigotine in patients with PD for up to 6 years the incidence of dyskinesia was low, and the dyskinesia was generally 'not disabling' or 'mildly disabling'.</AbstractText>
<CopyrightInformation>Copyright © 2014 Elsevier Ltd. All rights reserved.</CopyrightInformation>
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