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

摘要

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.