Abstract:
AIM:To evaluate the efficacy of glycopyrrolate oral solution (1 mg/5 mL) in managing problem drooling associated with cerebral palsy and other neurologic conditions. METHOD:Thirty-eight patients aged 3-23 years weighing at least 27 lb (12.2 kg) with severe drooling (clothing damp 5-7 days/week) were randomized to glycopyrrolate (n = 20), 0.02-0.1 mg/kg three times a day, or matching placebo (n = 18). Primary efficacy endpoint was responder rate, defined as percentage showing ≥3-point change on the modified Teacher's Drooling Scale (mTDS). RESULTS:Responder rate was significantly higher for the glycopyrrolate (14/19; 73.7%) than for the placebo (3/17; 17.6%) group (P = 0.0011), with improvements starting 2 weeks after treatment initiation. Mean improvements in mTDS at week 8 were significantly greater in the glycopyrrolate than in the placebo group (3.94 ± 1.95 vs 0.71 ± 2.14 points; P < 0.0001). In addition, 84% of physicians and 100% of parents/caregivers regarded glycopyrrolate as worthwhile compared with 41% and 56%, respectively, for placebo (P ≤ 0.014). Most frequently reported treatment-emergent adverse events (glycopyrrolate vs placebo) were dry mouth, constipation, and vomiting. INTERPRETATION:Children aged 3-16 years with problem drooling due to neurologic conditions showed a significantly better response, as assessed by mTDS, to glycopyrrolate than to placebo. CLINICALTRIALS.GOV IDENTIFIER: NCT00425087.
journal_name
Ther Clin Risk Managjournal_title
Therapeutics and clinical risk managementauthors
Zeller RS,Lee HM,Cavanaugh PF,Davidson Jdoi
10.2147/TCRM.S26893subject
Has Abstractpub_date
2012-01-01 00:00:00pages
15-23eissn
1176-6336issn
1178-203Xpii
tcrm-8-015journal_volume
8pub_type
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journal_title:Therapeutics and clinical risk management
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