Glycopyrronium Bromide Effective for Sialorrhoea in Patients With Parkinson's Disease, Without Unwanted Side Effects: Presented at MDS
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Glycopyrronium Bromide Effective for Sialorrhoea in Patients With Parkinson's Disease, Without Unwanted Side Effects: Presented at MDS

By Jenny Powers

PARIS -- June 10, 2009 -- Sialorrhoea can be controlled by treatment with glycopyrronium bromide without the side effects such as drowsiness, confusion, memory impairment, or other central side effects seen with anticholinergic treatment, reported researchers here at the Movement Disorder Society's (MDS) 13th International Congress of Parkinson's Disease and Movement Disorders on June 8.

Maurits E. L. Arbouw, MD, Department of Clinical Pharmacy, University Medical Center Utrecht, Utrecht, the Netherlands, and colleagues designed this study to determine the efficacy and safety of glycopyrronium bromide 1 mg TID as treatment for sialorrhoea, which affects nearly 75% of patients with Parkinson's disease (PD).

Anticholinergics are often used to treat PD patients for this condition, but this therapy carries several unwanted side effects. Because many PD patients already suffer from cognitive defects, determining a medication that will not contribute to their impairment is desirable.

The researchers conducted a randomised, placebo-controlled, double-blind, crossover study in 23 patients with idiopathic PD. The study patients were aged 70.0 (+-7.8 standard deviation) years, and their disease duration was 10.2 (+-8.6) years.

The patients were randomised to receive glycopyrronium bromide 1 mg TID or placebo during week 2 of the 4-week study. Week 3 consisted of a washout followed by treatment as in week 2 of the crossed-over groups.

Sialorrhoea was scored daily by the patients or a caregiver by use of a sialorrhoea scoring scale that ranged from 1 (no sialorrhoea) to 9 (profuse sialorrhoea).

One patient was excluded from the efficacy analysis because of a protocol violation. In the 22 remaining patients, the mean sialorrhoea score significantly improved from 4.7 with placebo to 3.9 with drug (P = .048).

Clinically relevant improvement of at least 30% was seen in 41.9% of patients with glycopyrronium bromide versus 4.5% with placebo (P = .021).

At least some improvement was seen in 72.7% of the patients in the treatment group versus 22.7% in the placebo group. No significant differences in adverse events were seen.

Patients reported dry mouth more often with the drug treatment than with placebo, which the researchers attributed to be directly linked to the therapeutic effect of glycopyrronium bromide.

Funding for this study was provided by the Utrecht Institute for Pharmaceutical Sciences.

[Presentation title: Glycopyrroniumbromide for the Treatment of Sialorrhea in Parkinson's Disease. Abstract MO-180]

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