Long-term incobotulinumtoxinA treatment for chronic sialorrhea: Efficacy and safety over 64 weeks
| Autor: | János Csikós, Andrzej Friedman, Andrzej Bogucki, Andrew Blitzer, Christian Oehlwein, Fernando Pagan, Jarosław Sławek, Wolfgang H. Jost, Birgit Flatau-Baqué, Ulrike Dorsch, Stanisław Ochudło, Olaf Michel, Marta Banach |
|---|---|
| Přispěvatelé: | Surgical clinical sciences, Ear, nose & throat |
| Rok vydání: | 2020 |
| Předmět: |
Adult
Male 0301 basic medicine medicine.medical_specialty Time Factors Adolescent Clinical Neurology drooling Placebo Drooling Young Adult 03 medical and health sciences 0302 clinical medicine Double-Blind Method Swallowing Botulinum toxin Internal medicine Outcome Assessment Health Care medicine Parkinson's disease/Parkinsonism Humans Prospective Studies Botulinum Toxins Type A Adverse effect Aged Aged 80 and over Brain Diseases Sialorrhea business.industry Incidence (epidemiology) IncobotulinumtoxinA Parkinson Disease Middle Aged Dysphagia 030104 developmental biology Neuromuscular Agents Neurology Chronic Disease Female Neurology (clinical) Geriatrics and Gerontology medicine.symptom business 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | Parkinsonism & Related Disorders. 70:23-30 |
| ISSN: | 1353-8020 0209-1739 |
| Popis: | Background Botulinum neurotoxin (BoNT) is an effective treatment for chronic sialorrhea; however, reliable and robust evidence supporting long-term efficacy and safety is lacking. This study investigated the efficacy and safety of repeated incobotulinumtoxinA injections for chronic sialorrhea over 64 weeks. Methods Adults with sialorrhea were randomized (2:2:1) to incobotulinumtoxinA 75 U, incobotulinumtoxinA 100 U (n = 74 each), or placebo (n = 36) in the double-blind, placebo-controlled main period (NCT02091739). Eligible subjects entered the extension period and received dose-blinded incobotulinumtoxinA 75 or 100 U in three further 16±2-week injection cycles. Efficacy and safety assessments in subjects who received incobotulinumtoxinA throughout the study included unstimulated salivary flow rate (uSFR), subjects' Global Impression of Change Scale (GICS), Drooling Severity and Frequency Scale (DSFS), modified Radboud Oral Motor Inventory for Parkinson's Disease (mROMP) drooling, speech, and swallowing symptom scores, and incidence of adverse events (AEs). Results In total, 173/184 subjects (94%) completed the main period and entered the extension period; 141 subjects received incobotulinumtoxinA 75 U (n = 69) or 100 U (n = 72) in both periods. Mean uSFR decreased consistently with repeated incobotulinumtoxinA 75 and 100 U treatment and by −0.16 and −0.17, respectively, at the end-of-study visit. Subjects’ GICS, DSFS, and mROMP drooling scores also improved at all assessments. mROMP speech and swallowing scores remained stable. The most common treatment-related AEs during the extension period were dry mouth (4.4% and 11.1%) and dysphagia (1.5% and 4.2%). Conclusions Data support long-term efficacy and safety of repeated incobotulinumtoxinA treatment for sialorrhea, with no additional safety concerns reported over 64 weeks. |
| Databáze: | OpenAIRE |
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