MovDisordV3, Main, Exploration, bibRecord, 000F91

Safety and Efficacy of Botulinum Toxin Type B for Treatment of Sialorrhea in Parkinson's Disease: A Prospective Double-Blind Trial

Identifieur interne : 000F91 ( Main/Exploration ); précédent : 000F90; suivant : 000F92

Safety and Efficacy of Botulinum Toxin Type B for Treatment of Sialorrhea in Parkinson's Disease: A Prospective Double-Blind Trial

Auteurs : Robert Chinnapongse [États-Unis] ; Kristen Gullo [États-Unis] ; Paul Nemeth [États-Unis] ; YUXIN ZHANG [États-Unis] ; Lynn Griggs [États-Unis]

Source :

Movement disorders [ 0885-3185 ] ; 2012.

RBID : Pascal:12-0113816

Descripteurs français

Pascal (Inist)
- Maladie de Parkinson, Parkinsonisme, Pathologie du système nerveux, Sécurité, Bontoxilysin, Traitement, Sialorrhée, Prospective.
Wicri :
- topic : Prospective.

English descriptors

KwdEn :
- Bontoxilysin, Nervous system diseases, Parkinson disease, Parkinsonism, Prospective, Safety, Sialorrhea, Treatment.

Abstract

Sialorrhea (drooling) is a common symptom of Parkinson's disease (PD) that can significantly impair a patient's health and quality of life. Fifty-four PD subjects with troublesome sialorrhea were enrolled using a multicenter, randomized, double-blind, sequential-dose escalation design in which subjects received a single intraglandular treatment with botulinum toxin type B (doses of 1,500 Units [0.3 mL]; 2,500 Units [0.5 ml]; or 3,500 Units [0.7 ml]) or placebo. Postinjection, subjects were followed acutely for 4 weeks and long-term for up to 20 weeks. Safety/tolerability, as assessed by adverse events, was the primary outcome measure. Efficacy, as assessed by the Drooling Frequency and Severity Scale and unstimulated salivary flow rate, was secondary. Gastrointestinal-related adverse events occurred more frequently in the active groups versus placebo group (31 % vs 7%), with dry mouth being most common (15%). There were no serious adverse events attributed to botulinum toxin type B or discontinuations due to adverse events from treatment. At 4 weeks postinjection, Drooling Frequency and Severity Scale scores significantly improved versus placebo (-1.3 ± 1.3) in a dose-related manner (-2.1 ± 1.2, P = 0.0191; -3.3 ± 1.4, P < 0.0001; -3.5 ± 1.1, P < 0.0001, respectively) and unstimulated salivary flow rates significantly decreased in all active groups versus placebo (P < 0.0009). Furthermore, treated subjects appeared to have more sustained improvement in sialorrhea than placebo subjects. We conclude that intraglandular injection of botulinum toxin type B was safe, tolerable, and efficacious in treating sialorrhea in PD patients. Additional studies are warranted to further confirm the drug's robust efficacy, as well as evaluate its effect with repeated dosing.

Affiliations:

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Le document en format XML

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<front><div type="abstract" xml:lang="en">Sialorrhea (drooling) is a common symptom of Parkinson's disease (PD) that can significantly impair a patient's health and quality of life. Fifty-four PD subjects with troublesome sialorrhea were enrolled using a multicenter, randomized, double-blind, sequential-dose escalation design in which subjects received a single intraglandular treatment with botulinum toxin type B (doses of 1,500 Units [0.3 mL]; 2,500 Units [0.5 ml]; or 3,500 Units [0.7 ml]) or placebo. Postinjection, subjects were followed acutely for 4 weeks and long-term for up to 20 weeks. Safety/tolerability, as assessed by adverse events, was the primary outcome measure. Efficacy, as assessed by the Drooling Frequency and Severity Scale and unstimulated salivary flow rate, was secondary. Gastrointestinal-related adverse events occurred more frequently in the active groups versus placebo group (31 % vs 7%), with dry mouth being most common (15%). There were no serious adverse events attributed to botulinum toxin type B or discontinuations due to adverse events from treatment. At 4 weeks postinjection, Drooling Frequency and Severity Scale scores significantly improved versus placebo (-1.3 ± 1.3) in a dose-related manner (-2.1 ± 1.2, P = 0.0191; -3.3 ± 1.4, P < 0.0001; -3.5 ± 1.1, P < 0.0001, respectively) and unstimulated salivary flow rates significantly decreased in all active groups versus placebo (P < 0.0009). Furthermore, treated subjects appeared to have more sustained improvement in sialorrhea than placebo subjects. We conclude that intraglandular injection of botulinum toxin type B was safe, tolerable, and efficacious in treating sialorrhea in PD patients. Additional studies are warranted to further confirm the drug's robust efficacy, as well as evaluate its effect with repeated dosing.</div>
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	Movement Disorders (revue)
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Movement Disorders (revue)

Safety and Efficacy of Botulinum Toxin Type B for Treatment of Sialorrhea in Parkinson's Disease: A Prospective Double-Blind Trial

Safety and Efficacy of Botulinum Toxin Type B for Treatment of Sialorrhea in Parkinson's Disease: A Prospective Double-Blind Trial

Source :

Descripteurs français

English descriptors

Abstract

Links toward previous steps (curation, corpus...)

Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

Pour mettre un lien sur cette page dans le réseau Wicri