Randomized, placebo-controlled trial of incobotulinumtoxina for upper-limb post-stroke spasticity
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
PubMed
26201835
PubMed Central
PMC5064747
DOI
10.1002/mus.24776
Knihovny.cz E-zdroje
- Klíčová slova
- Xeomin, botulinum toxins, type A, incobotulinumtoxinA, muscle spasticity, stroke,
- MeSH
- analýza rozptylu MeSH
- botulotoxiny typu A terapeutické užití MeSH
- cévní mozková příhoda komplikace MeSH
- dospělí MeSH
- dvojitá slepá metoda MeSH
- horní končetina patofyziologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- nervosvalové látky terapeutické užití MeSH
- retrospektivní studie MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- stupeň závažnosti nemoci MeSH
- svalová spasticita farmakoterapie etiologie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- botulotoxiny typu A MeSH
- incobotulinumtoxinA MeSH Prohlížeč
- nervosvalové látky MeSH
INTRODUCTION: Efficacy and safety of incobotulinumtoxinA in post-stroke upper-limb spasticity were studied. METHODS: Subjects randomized 2:1 to incobotulinumtoxinA (fixed dose 400 U) or placebo, with fixed doses for the primary target clinical pattern (PTCP; flexed elbow, 200 U; flexed wrist, 150 U; clenched fist, 100 U). Doses for non-primary patterns were flexible within predefined ranges. RESULTS: At week 4, incobotulinumtoxinA led to larger improvements in PTCP Ashworth scale (AS) scores than placebo [least-squares mean change ± standard error: -0.9 ± 0.06 (n = 171) vs. -0.5 ± 0.08 (n = 88); P < 0.001], and more subjects were PTCP AS responders (≥1-point improvement) with incobotulinumtoxinA (69.6%) than with placebo (37.5%; P < 0.001). Investigator's Global Impression of Change confirmed superiority of incobotulinumtoxinA vs. placebo (P = 0.003). IncobotulinumtoxinA was associated with functional improvements, as demonstrated in responder rates for Disability Assessment Scale principal target at week 4 (P = 0.007). Adverse events were mainly mild/moderate, and were reported by 22.4% (incobotulinumtoxinA) and 16.8% (placebo) of subjects. CONCLUSIONS: IncobotulinumtoxinA significantly improved upper-limb spasticity and associated disability, and was well-tolerated.
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