Glycopyrrolate for sialorrhea in Parkinson disease: a randomized, double-blind, crossover trial.
BACKGROUND
Sialorrhea affects approximately 75% of patients with Parkinson disease (PD). Sialorrhea is often treated with anticholinergics, but central side effects limit their usefulness. Glycopyrrolate (glycopyrronium bromide) is an anticholinergic drug with a quaternary ammonium structure not able to cross the blood-brain barrier in considerable amounts. Therefore, glycopyrrolate exhibits minimal central side effects, which may be an advantage in patients with PD, of whom a significant portion already experience cognitive deficits.


OBJECTIVE
To determine the efficacy and safety of glycopyrrolate in the treatment of sialorrhea in patients with PD.


METHODS
We conducted a 4-week, randomized, double-blind, placebo-controlled, crossover trial with oral glycopyrrolate 1 mg 3 times daily in 23 patients with PD. The severity of the sialorrhea was scored on a daily basis by the patients or a caregiver with a sialorrhea scoring scale ranging from 1 (no sialorrhea) to 9 (profuse sialorrhea).


RESULTS
The mean (SD) sialorrhea score improved from 4.6 (1.7) with placebo to 3.8 (1.6) with glycopyrrolate (p = 0.011). Nine patients (39.1%) with glycopyrrolate had a clinically relevant improvement of at least 30% vs 1 patient (4.3%) with placebo (p = 0.021). There were no significant differences in adverse events between glycopyrrolate and placebo treatment.


CONCLUSIONS
Oral glycopyrrolate 1 mg 3 times daily is an effective and safe therapy for sialorrhea in Parkinson disease.


METHODS
This study provides Class I evidence that glycopyrrolate 1 mg 3 times daily is more effective than placebo in reducing sialorrhea in patients with Parkinson disease during a 4-week study.
Arbouw
M E L
ME
Department of Clinical Pharmacy, Medisch Spectrum Twente, Enschede, the Netherlands.
Movig
K L L
KL
Koopmann
M
M
Poels
P J E
PJ
Guchelaar
H-J
HJ
Egberts
T C G
TC
Neef
C
C
van Vugt
J P P
JP
D000368:Aged; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006024:Glycopyrrolate / Q000008:administration & dosage*; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage; D010300:Parkinson Disease / Q000150:complications*; D012798:Sialorrhea / Q000188:drug therapy* / Q000209:etiology*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D018727:Muscarinic Antagonists; D006024:Glycopyrrolate