Highlights
- •Current guidelines suggested a dosage up to 600 units (U) of botulinum toxin type A (BoNT-A) in post-stroke spasticity
- •High doses of incobotulinumtoxinA (840U) showed efficacy and safety in severe post-stroke upper and lower limb spasticity
- •In a 2-year follow-up on 20 patients, a reduction of spasticity/disability was found with repeated high doses of incobotulinumtoxinA
- •One month after the last BoNT-A administration, the efficacy on spasticity/disability was similar to that at baseline
- •Long-term treatment with high doses of incobotulinumtoxinA was safe and effective in post-stroke upper and lower limb spasticity
Abstract
Current guidelines suggested a dosage up to 600 units (U) of botulinum toxin type A (BoNT-A) (onabotulinumtoxinA or incobotulinumtoxinA)
in reducing spastic hypertonia with low prevalence of complications, although a growing
body of evidence showed efficacy with the use of high doses (>800 U). The available evidence mainly referred to a single set of injections evaluating
the efficacy and safety of the neurotoxin 30 days after the treatment. In a prospective, non-randomized, open-label study, we studied
the safety of repeated higher doses of incobotulinumtoxinA in post-stroke upper and
lower limb spasticity.
Two years after the first set of injections, we evaluated in 20 stroke survivors with
upper and lower limb spasticity the long-term safety of repeated high doses of incobotulinumtoxinA
(up to 840 U) for a total of eight sets of injections.
Patients reported an improvement of their clinical picture concerning a reduction
of spasticity measured with the Asworth Scale (AS) for elbow, wrist, fingers and ankle
flexor muscles and disability measured with the Disability Assessment Scale (DAS)
30 days after the last set of injections (eighth set) compared to the baseline (p < 0.0001). No difference in AS and DAS scores has been found between t1 (30 days after the first injection set) and t2 (30 days after the eighth set of injections), with also similar safety.
In a two-year follow-up, repeated high doses of incobotulinumtoxinA, administered
for eight sets of injections, appeared to be safe in patients with upper and lower
limb spasticity after stroke without general adverse effects.
Keywords
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Article info
Publication history
Published online: May 01, 2017
Accepted:
April 30,
2017
Received in revised form:
April 11,
2017
Received:
January 21,
2017
Identification
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© 2017 Elsevier B.V. All rights reserved.