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Open-Label Study of Sleep Disturbances in Patients with Parkinson’s Disease Treated with Rasagiline

  • Michel Panisset (a1), Jean-Louis Stril (a2), Manon Bélanger (a2), Geneviève Lehoux (a2), Donna Coffin (a3) and Sylvain Chouinard (a1)...

Abstract

Background: The prevalence of sleep disturbances among patients with Parkinson’s disease (PD) is estimated to occur in 37% to 98% of patients. Sleep disturbances have been associated with a reduced quality of life for patients with PD. The objective of this study was to assess the impact of rasagiline treatment on the severity of sleep disturbances among patients with idiopathic PD. Methods: In this open-label, multicentre study, 110 adult patients with idiopathic PD were treated with rasagiline either as monotherapy or as adjunct therapy. The primary endpoint was the change in severity of sleep disturbances, assessed with the PD Sleep Scale from baseline to month 2. Exploratory endpoints included change in daytime sleepiness, assessed with the Epworth Sleep Scale, treatment satisfaction measured with the Treatment Satisfaction Questionnaire for Medication, patient’s overall improvement or deterioration over time measured with the Clinical Global Impression of Improvement, tolerability, and safety. Findings: Patients treated with rasagiline as mono- or adjunct therapy showed a statistically significant improvement in sleep quality after 2 months. There was no change in daytime sleepiness. Overall, patients were satisfied with rasagiline treatment with a mean Treatment Satisfaction Questionnaire for Medication [standard deviation] total score at month 2 of 68% [16.1]. At the end of study, 64 patients (65.9%) were judged, by the investigator, as being at least minimally improved from baseline on the Clinical Global Impression of Improvement. Rasagiline was safe and well-tolerated. Interpretation: Rasagiline as mono- or adjunct-therapy may improve sleep experience in patients with PD in the short term.

Étude ouverte sur les troubles du sommeil chez les patients atteints de la maladie de Parkinson qui sont traités par la rasagiline. Contexte : La prévalence des troubles du sommeil chez les patients atteints de la maladie de Parkinson (MP) serait de 37% à 98%. Les troubles du sommeil ont été associés à une qualité de vie diminuée chez ces patients. L’objectif de cette étude était d’évaluer l’impact du traitement par la rasagiline sur la sévérité des troubles du sommeil chez les patients atteints d’une MP idiopathique. Méthodologie : Dans cette étude multicentrique ouverte, 110 patients adultes atteints de MP idiopathique ont été traités par la rasagiline, soit en monothérapie ou comme traitement d’appoint. Le critère d’évaluation principal était le changement dans la sévérité des troubles du sommeil évalué au moyen de l’échelle du sommeil pour la MP au début de l’étude et après 2 mois de traitement. Les critères d’évaluation exploratoires incluaient le changement dans la somnolence diurne évalué au moyen de l’échelle de somnolence d’Epworth, la satisfaction par rapport au traitement mesurée au moyen du Treatment Satisfaction Questionnaire for Medication, l’amélioration ou la détérioration globale du patient dans le temps mesurée au moyen du questionnaire sur l’impression clinique globale d’amélioration, de tolérabilité et de sécurité. Résultats : Les patients traités par la rasagiline en monothérapie ou comme traitement d’appoint éprouvaient une amélioration significative au point de vue statistique de la qualité du sommeil après 2 mois de traitement. La somnolence diurne demeurait inchangée. Globalement, les patients étaient satisfaits du traitement par la rasagiline et le score total moyen au Treatment Satisfaction Questionnaire for Medication était de 68% (écart type 16,1) après 2 mois. Le chercheur considérait que 64 patients (65,9%) présentaient une amélioration au moins minimale par rapport à l’évaluation initiale à l’échelle d’impression clinique globale d’amélioration. La rasagiline était sûre et bien tolérée. Conclusion : La rasagiline en monothérapie ou comme traitement d’appoint peut améliorer le sommeil à court terme chez les patients atteints de la MP.

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Copyright

Corresponding author

Correspondence to: Michel Panisset, CHUM - Hôpital Notre-Dame, Montreal, Québec, 1560, rue Sherbrooke Est, Montréal, Québec, H2L 4M1 Canada. Email: michel.panisset@umontreal.ca.

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Keywords

Open-Label Study of Sleep Disturbances in Patients with Parkinson’s Disease Treated with Rasagiline

  • Michel Panisset (a1), Jean-Louis Stril (a2), Manon Bélanger (a2), Geneviève Lehoux (a2), Donna Coffin (a3) and Sylvain Chouinard (a1)...

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