title: 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.
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.
authors.affiliation: Department of Neurology, University of Freiburg, Breisacher Str. 64, 79106 Freiburg, Germany. Electronic address: w.jost@parkinson-klinik.de.
authors.forename: Wolfgang H
authors.initials: WH
authors.lastname: Jost
authors.affiliation: Department of Neurology, University of Duesseldorf, Moorenstrasse 5, 40225 Duesseldorf, Germany.
authors.forename: Harald
authors.initials: H
authors.lastname: Hefter
authors.affiliation: Ipsen Pharma, Willy-Brandt-Strasse 3, 76275 Ettlingen, Germany.
authors.forename: Andrea
authors.initials: A
authors.lastname: Reissig
authors.affiliation: Department of Neurology, Medical School Hannover, Carl-Neuberg-Straße 1, 30625 Hannover, Germany.
authors.forename: Katja
authors.initials: K
authors.lastname: Kollewe
authors.affiliation: Department of Neurorehabilitation and Physical Therapy, Vivantes Hospital Berlin Spandau, Neue Bergstrasse 6, 13585 Berlin, Germany.
authors.forename: Joerg
authors.initials: J
authors.lastname: Wissel
mesh_terms: D000328:Adult; D000368:Aged; D001132:Arm / Q000503:physiopathology*; D001317:Austria; D019274:Botulinum Toxins, Type A / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005858:Germany; D006801:Humans; D007391:International Cooperation; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009128:Muscle Spasticity / Q000188:drug therapy* / Q000209:etiology; D009465:Neuromuscular Agents / Q000627:therapeutic use*; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D012720:Severity of Illness Index; D020521:Stroke / Q000150:complications; D055815:Young Adult
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A; C542869:abobotulinumtoxinA
keywords: AbobotulinumtoxinA; Arm spasticity; Botulinum toxin type A; Dysport; Post-stroke spasticity; Stroke