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

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.

Author information

1
Department of Neurology, University of Freiburg, Breisacher Str. 64, 79106 Freiburg, Germany. Electronic address: w.jost@parkinson-klinik.de.
2
Department of Neurology, University of Duesseldorf, Moorenstrasse 5, 40225 Duesseldorf, Germany.
3
Ipsen Pharma, Willy-Brandt-Strasse 3, 76275 Ettlingen, Germany.
4
Department of Neurology, Medical School Hannover, Carl-Neuberg-Stra├če 1, 30625 Hannover, Germany.
5
Department of Neurorehabilitation and Physical Therapy, Vivantes Hospital Berlin Spandau, Neue Bergstrasse 6, 13585 Berlin, Germany.

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

PMID:
24361062
DOI:
10.1016/j.jns.2013.11.022
[Indexed for MEDLINE]
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