Long-term safety of repeated high doses of botulinumtoxinA injections for the treatment of upper and lower limb spasticity after stroke: a prospective, non-randomized, open-label studyName : Dr. Andrea Santamato
Affliation : Professor
University : University of Foggia
Country : Italy
Background: Spasticity is a common disabling symptom for several neurological conditions. Botulinum toxin type A injection represents the gold standard treatment for focal spasticity with efficacy, reversibility, and low prevalence of complications. Current guidelines suggest a dose up to 600 units (U) of onabotulinumtoxinA/incobotulinumtoxinA or up to 1500 U of abobotulinumtoxinA to treat post-stroke spasticity to avoid important adverse effects, even if some published researches showed safety and effectiveness of high doses (>800 U) administered in stroke survivors with upper and lower limb spasticity.
Materials and methods: in a prospective, non-randomized, open-label study, 20 stroke survivors with upper and lower limb spasticity treated with high doses of incobotulinumtoxinA (up to 840 U) for two years, were evaluated.
Results: a significant muscle tone reduction measured with the Ashworth Scale (AS) have been observed for all muscles injected with incobotulinumtoxinA and a significant functional improvement, assessed with the Disability Assessment Scale (DAS) were reported 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 (30 days after the first injection set) and 30 days after the eighth set of injections, with also similar safety.
Conclusions: repeated high doses of incobotulinumtoxinA, administered for eight sets of injections, have been considered safe and effectiveness for spasticity and disability in chronic stroke subjects with upper and lower limb spasticity .
Andrea Santamato was born in Bari-Italy on November 17th, 1974.
On February 28th, 2000 he obtained his degree in Medicine at the University of Bari
On November 2004, at the University of Bari he obtained, his specialization in Physical Therapy and Rehabilitation.
On November 1st 2008 he became a "University Researcher" at University of Foggia.
He is Chief of Spasticity and Movement Disorders therapies’s Service at Dept of Physical and Rehabilitation Unit. “Riuniti” Hospital, Foggia
His research studies have been aimed at the various aspects of Clinical Neurorehabilitation, especially botulinum toxin and spasticity, movement disorders, physical therapies.
Author of approximately 150 scientific papers into National and International journals, reviewer for several international journal