Journal
CLINICAL NEUROPHARMACOLOGY
Volume 39, Issue 2, Pages 88-93Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/WNF.0000000000000133
Keywords
dopamine receptor agonist; efficacy profile; motor fluctuations
Categories
Funding
- UCB Pharma
- Monheim am Rhein, Germany
- AbbVie
- Acorda
- Adamas
- Biotie
- Kyowa Hakko
- Allergan
- AstraZeneca
- BIAL
- Boehringer Ingelheim
- Boston Scientific
- GlaxoSmithKline
- Ipsen
- Lundbeck
- Medtronic
- MSD
- Merck Serono
- Merz Pharmaceuticals
- Novartis
- Orion Pharma
- TEVA Pharmaceuticals
- Zambon
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Objectives Transdermal delivery of rotigotine maintains stable plasma concentrations for 24 hours. Three phase 3 studies of rotigotine as add-on to levodopa in advanced Parkinson's disease showed a significant reduction in off time from baseline to end of maintenance (EoM). However, detailed analyses over the range of a day have not yet been performed. The objective was to examine the time course of the efficacy profile of rotigotine throughout the day. Methods Post hoc analysis of diary data from 3 double-blind, placebo-controlled studies of rotigotine in patients with advanced Parkinson's disease inadequately controlled with levodopa, with average off time of 2.5 h/d (CLEOPATRA-PD [NCT00244387], 16-week maintenance; PREFER, 24-week maintenance; SP921 [NCT00522379], 12-week maintenance). Patients marked 30-minute intervals as off, on without troublesome dyskinesia, on with troublesome dyskinesia, or sleep. Diaries completed on the 3 days before EoM were analyzed. A 2-sample t test was performed for comparison of rotigotine + levodopa versus placebo + levodopa for mean percentage of time per status during four 6-hour periods: 12:00am (midnight) to 6:00am, 6:00am to 12:00pm (noon), noon to 6:00pm, and 6:00pm to midnight. Results Data were available for 967 patients (placebo + levodopa, 260; rotigotine + levodopa, 707). During the 24-hour period at EoM, an advantage in mean percentage time spent off and on without troublesome dyskinesia was observed with rotigotine + levodopa versus placebo + levodopa during the three 6-hour periods from 6:00am to midnight (P < 0.05; exploratory analysis). Conclusions These exploratory analyses of patients with motor fluctuations suggest that the efficacy of rotigotine transdermal patch, as captured by diary data, in reducing off time and increasing on time without troublesome dyskinesia may cover the full waking day.
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