Movement disorders : official journal of the Movement Disorder Society · 2020
Glycopyrrolate Improves Disability From Sialorrhea in Parkinson's Disease: A 12-Week Controlled Trial.
Клиническое исследование II фазыСтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Mestre Tiago A, Freitas Eliza, Basndwah Ahmed, Lopez Marta Ruiz, de Oliveira Lais Machado, Al-Shorafat Duha Mohammed, Zhang Tinghua, Lui Jane P, Grimes David, Fox Susan H
Аннотация
OBJECTIVE: The objective of this study was to assess the 12-week efficacy and safety of oral glycopyrrolate for moderate-to-severe sialorrhea in Parkinson's disease (PD).
BACKGROUND: Chronic moderate-to-severe sialorrhea has a negative impact on quality of life in PD. There is no robust evidence for oral treatments for sialorrhea longer than 1 week.
METHODS: This was a 12-week, double-blinded, placebo-controlled, parallel phase II study in patients with PD and Movement Disorder Society-Unified Parkinson's Disease Rating Scale item 2.2 > 2. The intervention was glycopyrrolate up to 4.5 mg/d; the primary outcome was sialorrhea related-disability (Radboud Oral Motor Inventory for Parkinson's Disease-Saliva). We used an intention-to-treat analysis. A P < 0.05 was deemed significant.
RESULTS: We recruited 28 patients (age, 71.1 ± 6.9 years; PD duration, 11.4 ± 7.2 years; Radboud Oral Motor Inventory for Parkinson's Disease-Saliva, 22.4 ± 5.7). Glycopyrrolate was superior to placebo at 12 weeks in the Radboud Oral Motor Inventory for Parkinson's Disease-Saliva (between-group difference, 5.3; 95% confidence interval, 1.0-9.6). Dry mouth was the most common adverse event (glycopyrrolate, n = 6; placebo, n = 2).
CONCLUSIONS: The results support the efficacy of glycopyrrolate to treat sialorrhea-related disability up to 12 weeks and contribute to addressing unmet nonmotor care needs in PD. © 2020 International Parkinson and Movement Disorder Society.
BACKGROUND: Chronic moderate-to-severe sialorrhea has a negative impact on quality of life in PD. There is no robust evidence for oral treatments for sialorrhea longer than 1 week.
METHODS: This was a 12-week, double-blinded, placebo-controlled, parallel phase II study in patients with PD and Movement Disorder Society-Unified Parkinson's Disease Rating Scale item 2.2 > 2. The intervention was glycopyrrolate up to 4.5 mg/d; the primary outcome was sialorrhea related-disability (Radboud Oral Motor Inventory for Parkinson's Disease-Saliva). We used an intention-to-treat analysis. A P < 0.05 was deemed significant.
RESULTS: We recruited 28 patients (age, 71.1 ± 6.9 years; PD duration, 11.4 ± 7.2 years; Radboud Oral Motor Inventory for Parkinson's Disease-Saliva, 22.4 ± 5.7). Glycopyrrolate was superior to placebo at 12 weeks in the Radboud Oral Motor Inventory for Parkinson's Disease-Saliva (between-group difference, 5.3; 95% confidence interval, 1.0-9.6). Dry mouth was the most common adverse event (glycopyrrolate, n = 6; placebo, n = 2).
CONCLUSIONS: The results support the efficacy of glycopyrrolate to treat sialorrhea-related disability up to 12 weeks and contribute to addressing unmet nonmotor care needs in PD. © 2020 International Parkinson and Movement Disorder Society.