Efficacy and safety of botulinum toxin type A (Dysport) for the treatment of post-stroke arm spasticity: results of the German-Austrian open-label post-marketing surveillance prospective study

J Neurol Sci. 2014 Feb 15;337(1-2):86-90. doi: 10.1016/j.jns.2013.11.022. Epub 2013 Nov 22.

Abstract

The current practice in Germany and Austria, and the safety and efficacy of botulinum toxin type A (BoNT-A; Dysport) in the treatment of patients with post-stroke arm spasticity (with no fixed upper-limb contractures), were assessed in this observational prospective non-interventional study. One treatment cycle was documented with assessments at baseline, approximately week 4 (optional), and approximately week 12. Pattern of spasticity, treatment goal, safety and efficacy were recorded. Overall response and goal achievement was rated on a 4-point scale ('no goal achievement', 'goal achievement', 'good goal achievement', 'best goal achievement'). In total, 409 patients were included and 99% assigned to one of five arm-spasticity patterns. Therapy goals included reduced muscle tone (92.6%), physiotherapy or occupational therapy support (63.8%), increased range of motion (61.8%), pain reduction (58.9%), facilitation of care or hygiene (55.7%), and functional improvement (17.0%). Goals were achieved in 84% of patients. The following factors had the most potential as predictors of treatment outcome: pre-treatment; time since onset of spasticity; pattern of arm spasticity. Mean Dysport dose was 728 U and an inverse dose-response relationship was observed. Treatment was well tolerated. 500-1000 U was a safe and effective treatment for post-stroke arm spasticity in this post-marketing evaluation.

Keywords: AbobotulinumtoxinA; Arm spasticity; Botulinum toxin type A; Dysport; Post-stroke spasticity; Stroke.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Arm / physiopathology*
  • Austria
  • Botulinum Toxins, Type A / therapeutic use*
  • Dose-Response Relationship, Drug
  • Female
  • Germany
  • Humans
  • International Cooperation
  • Logistic Models
  • Male
  • Middle Aged
  • Muscle Spasticity / drug therapy*
  • Muscle Spasticity / etiology
  • Neuromuscular Agents / therapeutic use*
  • Product Surveillance, Postmarketing*
  • Prospective Studies
  • Severity of Illness Index
  • Stroke / complications
  • Young Adult

Substances

  • Neuromuscular Agents
  • Botulinum Toxins, Type A
  • abobotulinumtoxinA