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Rotigotine in Combination with the MAO-B Inhibitor Selegiline in Early Parkinson's Disease: A Post Hoc Analysis.
J Parkinsons Dis. 2016 04 02; 6(2):401-11.JP

Abstract

BACKGROUND

Monoamine oxidase B (MAO-B) inhibitors and dopamine receptor agonists are common first-line treatment options in early Parkinson's disease (PD).

OBJECTIVE

To evaluate the efficacy and safety of rotigotine transdermal patch as an add-on therapy to an MAO-B inhibitor in patients with early-PD.

METHODS

In two Phase III, randomized, double-blind, placebo-controlled studies in early-PD (SP512, SP513), patients were randomized to rotigotine (titrated to optimal dose ≤8 mg/24 h) or placebo, and maintained for 24 (SP512) or 33 (SP513) weeks. Post hoc analyses were performed on pooled data for patients receiving an MAO-B inhibitor (selegiline) at a stable dose at randomization and throughout the studies, with groups defined as "Selegiline+Rotigotine" and "Selegiline+Placebo". Outcome measures included change from baseline in Unified Parkinson's Disease Rating Scale (UPDRS) II (activities of daily living), III (motor), UPDRS II+III and responders (patients achieving ≥20%, ≥25% or ≥30% decrease in UPDRS II+III). As post hoc analyses, p-values are exploratory.

RESULTS

130 patients were evaluable for efficacy analyses ("Selegiline+Rotigotine": 84, "Selegiline+Placebo": 46). Combined treatment with rotigotine and selegiline improved UPDRS III and UPDRS II+III scores versus selegiline alone (LS-mean [95% CI] treatment difference for UPDRS III: -4.89 [-7.87 to -1.91], p = 0.0015; for UPDRS II+III: -5.76 [-9.71 to -1.82], p = 0.0045). Higher proportion of patients in the "Selegiline+Rotigotine" group were classified as ≥20%, ≥25% or ≥30% responders (all p < 0.001). Combined treatment appeared more effective in patients aged ≤65 years versus > 65 years (although patient numbers in the subgroups were low). Adverse event profile was consistent with the known safety profile of rotigotine.

CONCLUSIONS

In these post hoc analyses, adjunctive treatment with rotigotine in patients already receiving an MAO-B inhibitor improved UPDRS II+III score; this appeared to be largely driven by improvements in the motor aspects of PD.

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.UCB Pharma, Raleigh, NC, USA.UCB Pharma, Monheim am Rhein, Germany.UCB Pharma, Monheim am Rhein, Germany.UCB Pharma, Monheim am Rhein, Germany.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

27061066

Citation

Giladi, Nir, et al. "Rotigotine in Combination With the MAO-B Inhibitor Selegiline in Early Parkinson's Disease: a Post Hoc Analysis." Journal of Parkinson's Disease, vol. 6, no. 2, 2016, pp. 401-11.
Giladi N, Asgharnejad M, Bauer L, et al. Rotigotine in Combination with the MAO-B Inhibitor Selegiline in Early Parkinson's Disease: A Post Hoc Analysis. J Parkinsons Dis. 2016;6(2):401-11.
Giladi, N., Asgharnejad, M., Bauer, L., Grieger, F., & Boroojerdi, B. (2016). Rotigotine in Combination with the MAO-B Inhibitor Selegiline in Early Parkinson's Disease: A Post Hoc Analysis. Journal of Parkinson's Disease, 6(2), 401-11. https://doi.org/10.3233/JPD-150758
Giladi N, et al. Rotigotine in Combination With the MAO-B Inhibitor Selegiline in Early Parkinson's Disease: a Post Hoc Analysis. J Parkinsons Dis. 2016 04 2;6(2):401-11. PubMed PMID: 27061066.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Rotigotine in Combination with the MAO-B Inhibitor Selegiline in Early Parkinson's Disease: A Post Hoc Analysis. AU - Giladi,Nir, AU - Asgharnejad,Mahnaz, AU - Bauer,Lars, AU - Grieger,Frank, AU - Boroojerdi,Babak, PY - 2016/4/11/entrez PY - 2016/4/12/pubmed PY - 2017/10/31/medline KW - Dopamine receptor agonist KW - Parkinson’s disease KW - clinical trial KW - monoamine oxidase inhibitors SP - 401 EP - 11 JF - Journal of Parkinson's disease JO - J Parkinsons Dis VL - 6 IS - 2 N2 - BACKGROUND: Monoamine oxidase B (MAO-B) inhibitors and dopamine receptor agonists are common first-line treatment options in early Parkinson's disease (PD). OBJECTIVE: To evaluate the efficacy and safety of rotigotine transdermal patch as an add-on therapy to an MAO-B inhibitor in patients with early-PD. METHODS: In two Phase III, randomized, double-blind, placebo-controlled studies in early-PD (SP512, SP513), patients were randomized to rotigotine (titrated to optimal dose ≤8 mg/24 h) or placebo, and maintained for 24 (SP512) or 33 (SP513) weeks. Post hoc analyses were performed on pooled data for patients receiving an MAO-B inhibitor (selegiline) at a stable dose at randomization and throughout the studies, with groups defined as "Selegiline+Rotigotine" and "Selegiline+Placebo". Outcome measures included change from baseline in Unified Parkinson's Disease Rating Scale (UPDRS) II (activities of daily living), III (motor), UPDRS II+III and responders (patients achieving ≥20%, ≥25% or ≥30% decrease in UPDRS II+III). As post hoc analyses, p-values are exploratory. RESULTS: 130 patients were evaluable for efficacy analyses ("Selegiline+Rotigotine": 84, "Selegiline+Placebo": 46). Combined treatment with rotigotine and selegiline improved UPDRS III and UPDRS II+III scores versus selegiline alone (LS-mean [95% CI] treatment difference for UPDRS III: -4.89 [-7.87 to -1.91], p = 0.0015; for UPDRS II+III: -5.76 [-9.71 to -1.82], p = 0.0045). Higher proportion of patients in the "Selegiline+Rotigotine" group were classified as ≥20%, ≥25% or ≥30% responders (all p < 0.001). Combined treatment appeared more effective in patients aged ≤65 years versus > 65 years (although patient numbers in the subgroups were low). Adverse event profile was consistent with the known safety profile of rotigotine. CONCLUSIONS: In these post hoc analyses, adjunctive treatment with rotigotine in patients already receiving an MAO-B inhibitor improved UPDRS II+III score; this appeared to be largely driven by improvements in the motor aspects of PD. SN - 1877-718X UR - https://www.unboundmedicine.com/medline/citation/27061066/Rotigotine_in_Combination_with_the_MAO_B_Inhibitor_Selegiline_in_Early_Parkinson's_Disease:_A_Post_Hoc_Analysis_ L2 - https://content.iospress.com/openurl?genre=article&amp;id=doi:10.3233/JPD-150758 DB - PRIME DP - Unbound Medicine ER -