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Efficacy of Rotigotine at Different Stages of Parkinson's Disease Symptom Severity and Disability: A Post Hoc Analysis According to Baseline Hoehn and Yahr Stage.
J Parkinsons Dis. 2016 10 19; 6(4):741-749.JP

Abstract

BACKGROUND

The efficacy of rotigotine has been demonstrated in studies of patients with early (i.e. not receiving levodopa) and advanced (i.e. not adequately controlled on levodopa; average 2.5 h/day in 'off' state) Parkinson's disease (PD).

OBJECTIVE

To further investigate the efficacy of rotigotine transdermal patch across different stages of PD symptom severity and functional disability, according to baseline Hoehn and Yahr (HY) staging.

METHODS

Post hoc analysis of six placebo-controlled studies of rotigotine in patients with early PD (SP506, SP512, SP513; rotigotine ≤8 mg/24 h) or advanced-PD (CLEOPATRA-PD, PREFER, SP921; rotigotine ≤16 mg/24 h). Data were pooled and analyzed according to baseline HY stage (1, 2, 3 or 4) for change from baseline to end of maintenance in Unified Parkinson's Disease Rating Scale (UPDRS) II (activities of daily living), UPDRS III (motor) and UPDRS II+III; statistical tests are exploratory.

RESULTS

Data were available for 2057 patients (HY 1 : 262; HY 2 : 1230; HY 3 : 524; HY 4 : 41). Patients at higher HY stages were older, had a longer time since PD diagnosis and higher baseline UPDRS II+III scores vs patients at lower HY stages. Rotigotine improved UPDRS II+III versus placebo for each individual HY stage (p < 0.05 for each HY stage), with treatment differences increasing with increasing HY stages. Similar results were observed for UPDRS II and UPDRS III.

CONCLUSIONS

This post hoc analysis suggests that rotigotine may be efficacious across a broad range of progressive stages of PD symptom severity and functional disability (HY stages 1-4).

Authors+Show Affiliations

Chairman of the Neurological Institute, Tel Aviv Medical Center, Director of the Department of Neurology and Neurosurgery, Sackler School of Medicine, Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel.Department of Neurology, University of Alabama at Birmingham and Birmingham VA Medical Center, Birmingham, AL, USA.UCB Pharma, Raleigh, NC, USA.UCB Pharma, Brussels, Belgium.UCB Pharma, Monheim am Rhein, Germany.UCB Pharma, Monheim am Rhein, Germany.Department of Neurology, Medical University Innsbruck, Innsbruck, Austria.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

27567886

Citation

Giladi, Nir, et al. "Efficacy of Rotigotine at Different Stages of Parkinson's Disease Symptom Severity and Disability: a Post Hoc Analysis According to Baseline Hoehn and Yahr Stage." Journal of Parkinson's Disease, vol. 6, no. 4, 2016, pp. 741-749.
Giladi N, Nicholas AP, Asgharnejad M, et al. Efficacy of Rotigotine at Different Stages of Parkinson's Disease Symptom Severity and Disability: A Post Hoc Analysis According to Baseline Hoehn and Yahr Stage. J Parkinsons Dis. 2016;6(4):741-749.
Giladi, N., Nicholas, A. P., Asgharnejad, M., Dohin, E., Woltering, F., Bauer, L., & Poewe, W. (2016). Efficacy of Rotigotine at Different Stages of Parkinson's Disease Symptom Severity and Disability: A Post Hoc Analysis According to Baseline Hoehn and Yahr Stage. Journal of Parkinson's Disease, 6(4), 741-749.
Giladi N, et al. Efficacy of Rotigotine at Different Stages of Parkinson's Disease Symptom Severity and Disability: a Post Hoc Analysis According to Baseline Hoehn and Yahr Stage. J Parkinsons Dis. 2016 10 19;6(4):741-749. PubMed PMID: 27567886.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of Rotigotine at Different Stages of Parkinson's Disease Symptom Severity and Disability: A Post Hoc Analysis According to Baseline Hoehn and Yahr Stage. AU - Giladi,Nir, AU - Nicholas,Anthony P, AU - Asgharnejad,Mahnaz, AU - Dohin,Elisabeth, AU - Woltering,Franz, AU - Bauer,Lars, AU - Poewe,Werner, PY - 2016/10/22/pubmed PY - 2017/11/10/medline PY - 2016/8/29/entrez KW - Dopamine receptor agonist KW - Parkinson’s disease KW - clinical trial KW - disease progression KW - treatment efficacy SP - 741 EP - 749 JF - Journal of Parkinson's disease JO - J Parkinsons Dis VL - 6 IS - 4 N2 - BACKGROUND: The efficacy of rotigotine has been demonstrated in studies of patients with early (i.e. not receiving levodopa) and advanced (i.e. not adequately controlled on levodopa; average 2.5 h/day in 'off' state) Parkinson's disease (PD). OBJECTIVE: To further investigate the efficacy of rotigotine transdermal patch across different stages of PD symptom severity and functional disability, according to baseline Hoehn and Yahr (HY) staging. METHODS: Post hoc analysis of six placebo-controlled studies of rotigotine in patients with early PD (SP506, SP512, SP513; rotigotine ≤8 mg/24 h) or advanced-PD (CLEOPATRA-PD, PREFER, SP921; rotigotine ≤16 mg/24 h). Data were pooled and analyzed according to baseline HY stage (1, 2, 3 or 4) for change from baseline to end of maintenance in Unified Parkinson's Disease Rating Scale (UPDRS) II (activities of daily living), UPDRS III (motor) and UPDRS II+III; statistical tests are exploratory. RESULTS: Data were available for 2057 patients (HY 1 : 262; HY 2 : 1230; HY 3 : 524; HY 4 : 41). Patients at higher HY stages were older, had a longer time since PD diagnosis and higher baseline UPDRS II+III scores vs patients at lower HY stages. Rotigotine improved UPDRS II+III versus placebo for each individual HY stage (p < 0.05 for each HY stage), with treatment differences increasing with increasing HY stages. Similar results were observed for UPDRS II and UPDRS III. CONCLUSIONS: This post hoc analysis suggests that rotigotine may be efficacious across a broad range of progressive stages of PD symptom severity and functional disability (HY stages 1-4). SN - 1877-718X UR - https://www.unboundmedicine.com/medline/citation/27567886/Efficacy_of_Rotigotine_at_Different_Stages_of_Parkinson's_Disease_Symptom_Severity_and_Disability:_A_Post_Hoc_Analysis_According_to_Baseline_Hoehn_and_Yahr_Stage_ L2 - https://content.iospress.com/openurl?genre=article&amp;id=doi:10.3233/JPD-160847 DB - PRIME DP - Unbound Medicine ER -