title: Dysport (botulinum toxin type A) in routine therapeutic usage: a telephone needs assessment survey of European physicians to evaluate current awareness and adherence to product labeling changes.
abstract: BACKGROUND
  Botulinum neurotoxin type A is a well-established treatment for a number of conditions involving muscle hyperactivity. Dysport (Ipsen Ltd, Wrexham, United Kingdom) is a botulinum neurotoxin type A preparation that has been available for a number of therapeutic uses for over 20 years in the European Union (EU). This survey was part of the EU botulinum toxin risk management plan to identify potential educational needs of injectors by collecting data on their routine practice administration of Dysport and their awareness of potential adverse events (AEs) that are included in the current product labeling.
  
  
  METHODS
  Dysport-experienced injectors in 5 EU countries were surveyed via telephone about their experience of Dysport in patients with cervical dystonia, adult upper and lower limb spasticity, pediatric cerebral palsy, and blepharospasm/hemifacial spasm.
  
  
  RESULTS
  The reconstitution dilution volume most often used was 2.5 mL per 500 U for all indications. The mean total dose ranged from 387 to 530 U for cervical dystonia, 508 to 773 U for upper limb spasticity, 600 to 832 U for lower limb spasticity, 375 to 700 U for pediatric cerebral palsy, and 54 to 213 U for blepharospasm/hemifacial spasm. The potential AEs most commonly mentioned by surveyed physicians were dysphagia for cervical dystonia, arm muscle weakness for upper limb spasticity, leg muscle weakness for lower limb spasticity, and pediatric cerebral palsy and ptosis for blepharospasm/hemifacial spasm.
  
  
  CONCLUSIONS
  The results indicate that product-labeling recommendations are generally applied in clinical practice and that there is a good familiarity with potential AEs based on clinical condition. Nevertheless, the survey shows that experienced injectors do sometimes deviate from the manufacturers labeling recommendations, highlighting the importance of ongoing education.
authors.affiliation: Ipsen Biopharmaceuticals, Inc, Basking Ridge, NJ 07920, USA.
authors.forename: Jean
authors.initials: J
authors.lastname: Hubble
authors.forename: Joseph
authors.initials: J
authors.lastname: Schwab
authors.forename: Catherine
authors.initials: C
authors.lastname: Hubert
authors.forename: Chandra Coleman
authors.initials: CC
authors.lastname: Abbott
mesh_terms: D000328:Adult; D001763:Blepharoptosis / Q000209:etiology / Q000517:prevention & control*; D001764:Blepharospasm / Q000188:drug therapy / Q000503:physiopathology; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002547:Cerebral Palsy / Q000188:drug therapy / Q000503:physiopathology; D002648:Child; D002983:Clinical Competence; D003680:Deglutition Disorders / Q000209:etiology / Q000517:prevention & control*; D004348:Drug Labeling; D004502:Education, Medical, Continuing; D005062:European Union; D019983:Guideline Adherence; D019569:Hemifacial Spasm / Q000188:drug therapy / Q000503:physiopathology; D006801:Humans; D007273:Injections, Intramuscular; D009128:Muscle Spasticity / Q000188:drug therapy / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control; D018908:Muscle Weakness / Q000209:etiology / Q000517:prevention & control*; D020380:Needs Assessment; D056687:Off-Label Use; D060735:Pharmacovigilance; D010818:Practice Patterns, Physicians'; D014103:Torticollis / Q000188:drug therapy / Q000503:physiopathology
chemical_list: D019274:Botulinum Toxins, Type A; C542869:abobotulinumtoxinA