Cargando…
The Efficacy Profile of Rotigotine During the Waking Hours in Patients With Advanced Parkinson's Disease: A Post Hoc Analysis
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 ov...
Autores principales: | , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Lippincott Williams & Wilkins
2016
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4791317/ https://www.ncbi.nlm.nih.gov/pubmed/26882318 http://dx.doi.org/10.1097/WNF.0000000000000133 |
_version_ | 1782421068682625024 |
---|---|
author | LeWitt, Peter A. Poewe, Werner Elmer, Lawrence W. Asgharnejad, Mahnaz Boroojerdi, Babak Grieger, Frank Bauer, Lars |
author_facet | LeWitt, Peter A. Poewe, Werner Elmer, Lawrence W. Asgharnejad, Mahnaz Boroojerdi, Babak Grieger, Frank Bauer, Lars |
author_sort | LeWitt, Peter A. |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-4791317 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | Lippincott Williams & Wilkins |
record_format | MEDLINE/PubMed |
spelling | pubmed-47913172016-04-05 The Efficacy Profile of Rotigotine During the Waking Hours in Patients With Advanced Parkinson's Disease: A Post Hoc Analysis LeWitt, Peter A. Poewe, Werner Elmer, Lawrence W. Asgharnejad, Mahnaz Boroojerdi, Babak Grieger, Frank Bauer, Lars Clin Neuropharmacol Original Articles 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. Lippincott Williams & Wilkins 2016-03 2016-02-12 /pmc/articles/PMC4791317/ /pubmed/26882318 http://dx.doi.org/10.1097/WNF.0000000000000133 Text en Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved. This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially. |
spellingShingle | Original Articles LeWitt, Peter A. Poewe, Werner Elmer, Lawrence W. Asgharnejad, Mahnaz Boroojerdi, Babak Grieger, Frank Bauer, Lars The Efficacy Profile of Rotigotine During the Waking Hours in Patients With Advanced Parkinson's Disease: A Post Hoc Analysis |
title | The Efficacy Profile of Rotigotine During the Waking Hours in Patients With Advanced Parkinson's Disease: A Post Hoc Analysis |
title_full | The Efficacy Profile of Rotigotine During the Waking Hours in Patients With Advanced Parkinson's Disease: A Post Hoc Analysis |
title_fullStr | The Efficacy Profile of Rotigotine During the Waking Hours in Patients With Advanced Parkinson's Disease: A Post Hoc Analysis |
title_full_unstemmed | The Efficacy Profile of Rotigotine During the Waking Hours in Patients With Advanced Parkinson's Disease: A Post Hoc Analysis |
title_short | The Efficacy Profile of Rotigotine During the Waking Hours in Patients With Advanced Parkinson's Disease: A Post Hoc Analysis |
title_sort | efficacy profile of rotigotine during the waking hours in patients with advanced parkinson's disease: a post hoc analysis |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4791317/ https://www.ncbi.nlm.nih.gov/pubmed/26882318 http://dx.doi.org/10.1097/WNF.0000000000000133 |
work_keys_str_mv | AT lewittpetera theefficacyprofileofrotigotineduringthewakinghoursinpatientswithadvancedparkinsonsdiseaseaposthocanalysis AT poewewerner theefficacyprofileofrotigotineduringthewakinghoursinpatientswithadvancedparkinsonsdiseaseaposthocanalysis AT elmerlawrencew theefficacyprofileofrotigotineduringthewakinghoursinpatientswithadvancedparkinsonsdiseaseaposthocanalysis AT asgharnejadmahnaz theefficacyprofileofrotigotineduringthewakinghoursinpatientswithadvancedparkinsonsdiseaseaposthocanalysis AT boroojerdibabak theefficacyprofileofrotigotineduringthewakinghoursinpatientswithadvancedparkinsonsdiseaseaposthocanalysis AT griegerfrank theefficacyprofileofrotigotineduringthewakinghoursinpatientswithadvancedparkinsonsdiseaseaposthocanalysis AT bauerlars theefficacyprofileofrotigotineduringthewakinghoursinpatientswithadvancedparkinsonsdiseaseaposthocanalysis AT lewittpetera efficacyprofileofrotigotineduringthewakinghoursinpatientswithadvancedparkinsonsdiseaseaposthocanalysis AT poewewerner efficacyprofileofrotigotineduringthewakinghoursinpatientswithadvancedparkinsonsdiseaseaposthocanalysis AT elmerlawrencew efficacyprofileofrotigotineduringthewakinghoursinpatientswithadvancedparkinsonsdiseaseaposthocanalysis AT asgharnejadmahnaz efficacyprofileofrotigotineduringthewakinghoursinpatientswithadvancedparkinsonsdiseaseaposthocanalysis AT boroojerdibabak efficacyprofileofrotigotineduringthewakinghoursinpatientswithadvancedparkinsonsdiseaseaposthocanalysis AT griegerfrank efficacyprofileofrotigotineduringthewakinghoursinpatientswithadvancedparkinsonsdiseaseaposthocanalysis AT bauerlars efficacyprofileofrotigotineduringthewakinghoursinpatientswithadvancedparkinsonsdiseaseaposthocanalysis |