Effects of long-term treatment with rotigotine transdermal system on dyskinesia in patients with early-stage Parkinson's disease.

Abstract

PURPOSE:

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.

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.

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).

CONCLUSION:

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'.

• Authors: Nir Giladi, Liesbet Ghys, Erwin Surmann, Babak Boroojerdi, Joseph Jankovic
• Journal: Parkinsonism & related disorders (Parkinsonism Relat Disord) Vol. 20 Issue 12 Pg. 1345-51 (Dec 2014) ISSN: 1873-5126 [Electronic] England
• PMID: 25444083 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2014 Elsevier Ltd. All rights reserved.

Chemical References

• Antiparkinson Agents
• Tetrahydronaphthalenes
• Thiophenes
• Levodopa
• rotigotine

Topics

• 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, epidemiology, 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)