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Glycopyrrolate Improves Disability From Sialorrhea in Parkinson's Disease: A 12‐Week Controlled Trial
Author(s) -
Mestre Tiago A.,
Freitas Eliza,
Basndwah Ahmed,
Lopez Marta Ruiz,
Oliveira Lais Machado,
AlShorafat Duha Mohammed,
Zhang Tinghua,
Lui Jane P.,
Grimes David,
Fox Susan H.
Publication year - 2020
Publication title -
movement disorders
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.352
H-Index - 198
eISSN - 1531-8257
pISSN - 0885-3185
DOI - 10.1002/mds.28196
Subject(s) - glycopyrrolate , sialorrhea , parkinson's disease , medicine , physical therapy , physical medicine and rehabilitation , psychology , anesthesia , disease , atropine
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