Safety profile and efficacy of botulinum toxin A (Dysport) in children with muscle spasticity.
Botulinum toxin A (BTX-A) is widely used in the management of muscle spasticity in children. However, at present the dose of BTX-A for a given patient is selected empirically. The aim of this study is to provide dosage guidelines that are based on risk/benefit assessment. This was a multicentre retrospective study of the safety profile and efficacy of BTX-A in children with chronic muscle spasticity. Data in 758 patients who received a total of 1594 treatments were analysed (mean age 7.2 years; 429 males, 329 females). Spastic cerebral palsy (CP) was the most common diagnosis (94% of the study sample). Of all treatments 7% resulted in adverse events; incidence was related to the total dose rather than the dose calculated on the basis of body weight. The highest incidence of adverse events was observed in patients who received >1000 IU of BTX-A per treatment session. The odds of an adverse event was 5.1 times greater for this group of patients than for those who had 250 IU or less (p<0.001). A good overall response to treatment was reported in 82% and treatment goals were fully or partially achieved in 3% and 94% of participants respectively. More patients in the highest dose group reported functional deterioration. Interestingly, multilevel treatments resulted in a better response than single-level treatments (odds ratio 1.7, 95% CI 1.3 to 2.2,p=0.001).
Bakheit
A M
AM
University of Plymouth, Beauchamp Centre, Mount Gould Hospital, UK.
Severa
S
S
Cosgrove
A
A
Morton
R
R
Roussounis
S H
SH
Doderlein
L
L
Lin
J P
JP
Rousso
S H
SH
D000367:Age Factors; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage* / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D002908:Chronic Disease; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D009128:Muscle Spasticity / Q000188:drug therapy*; D009465:Neuromuscular Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D012189:Retrospective Studies; D018570:Risk Assessment
D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A