Long-term safety and tolerability of rotigotine transdermal system in patients with early-stage idiopathic Parkinsons disease: A prospective, open-label extension study
Parkinsonism & Related Disorders, 06/12/2012
Elmer LW et al. – This is the longest interventional study of rotigotine conducted to date. Transdermal rotigotine was generally well tolerated for up to 6 years; adverse events (AEs) reported were similar to those observed in shorter studies and led to discontinuation in only 24% patients.Methods
- Patients with early-stage idiopathic PD received transdermal rotigotine for up to 6 years at optimal dose (up to 16mg/24h).
- Adjunctive levodopa was allowed.
- Primary outcomes included adverse events (AEs) and extent of rotigotine exposure.
- Other outcomes included time to levodopa, incidence of dyskinesias, and efficacy using the Unified Parkinson’s Disease Rating Scale (UPDRS) II+III total score.
- Of 217 patients entering the open-label study, 47% were still in the study upon closure; 24% withdrew because of AEs and 6% because of lack of efficacy.
- The median exposure to rotigotine was 1910 days (5 years, 3 months; range 1-2188 days).
- Most common AEs were somnolence (23% per patient-year), falls (17%), peripheral edema (14%), nausea (12%), and application site reactions (ASRs; 12%).
- 3% withdrew because of ASRs.
- 26% patients did not initiate levodopa; of those who did, fewer than half started levodopa in the first year.
- Dyskinesias were reported by 25% patients; the majority (83%) reported their first episode after initiating levodopa.
- Mean UPDRS II+III total scores remained below double-blind baseline for up to 2 years of open-label treatment.