Pooled analysis of the safety of botulinum toxin type A in the treatment of poststroke spasticity.
OBJECTIVE
To examine the safety of botulinum toxin type A (BTX-A).


METHODS
Analysis of pooled data of 9 double-blind, placebo-controlled studies of patients with spasticity after stroke.


METHODS
University hospitals and specialty rehabilitation centers in the United States.


METHODS
A total of 482 patients with upper-limb spasticity and 310 with lower-limb spasticity (overall mean age, 58y; 60% men).


METHODS
Treatment with BTX-A (n=534; 1-3 treatments; mean dose, 231U) or placebo (n=258).


METHODS
Adverse events.


RESULTS
Most patients (69%) received only 1 treatment with BTX-A. Patients were followed for a mean of 17.8 weeks (range, 0.1-44.7wk) after each treatment. A total of 352 (65.9%) patients in the BTX-A group and 163 (63.2%) in the placebo group reported at least 1 adverse event (P=.475). The most frequent adverse events reported by patients (>5% but <10% in either group) were respiratory infection, seizures, incoordination, and injection site pain, none of which occurred at a significantly higher rate in the BTX-A group (all P>.05). The majority of adverse events were rated as mild or moderate in severity. Only nausea was reported at a significantly higher rate in the BTX-A group (12/534 [2.2%]) than the placebo group (0/258) (P=.011); in contrast, injection site pain, chest pain, and allergic reaction were reported significantly more frequently in the placebo group.


CONCLUSIONS
BTX-A has an acceptable safety profile for treatment of patients with focal spasticity following stroke, a population in which adverse events and comorbidities are common.
Turkel
Catherine C
CC
Clinical Development, Allergan Inc., 2525 Dupont Drive, Irvine, CA 92612, USA. Turkel_Catherine@Allergan.com
Bowen
Beta
B
Liu
Jingyu
J
Brin
Mitchell F
MF
D000328:Adult; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000009:adverse effects*; D016009:Chi-Square Distribution; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009128:Muscle Spasticity / Q000188:drug therapy* / Q000209:etiology; D009465:Neuromuscular Agents / Q000009:adverse effects*; D016032:Randomized Controlled Trials as Topic; D020521:Stroke / Q000150:complications*; D016896:Treatment Outcome
D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A