PMID- 22878514
OWN - NLM
STAT- MEDLINE
DCOM- 20130719
LR  - 20220318
IS  - 1435-1463 (Electronic)
IS  - 0300-9564 (Linking)
VI  - 120
IP  - 2
DP  - 2013 Feb
TI  - AbobotulinumtoxinA (Dysport) dosing in cervical dystonia: an exploratory analysis 
      of two large open-label extension studies.
PG  - 299-307
LID - 10.1007/s00702-012-0872-1 [doi]
AB  - Treatment with botulinum toxin-A is recommended as first-line treatment for 
      cervical dystonia (CD). In clinical practice many factors appear to influence 
      dose adjustment and the retreatment regimen; however, there is little information 
      available in the literature regarding the evolution of dosing over treatment 
      cycles. We report on two similarly designed, long-term, multicenter, open-label 
      extension studies of Dysport for the treatment of CD, which followed 500 U 
      fixed-dose placebo-controlled trials. Both studies specified a fixed 500 U dose 
      for the first open-label treatment cycle, with dose adjustment in subsequent 
      treatment cycles according to the clinical response. These analyses include 218 
      patients who entered the two studies; doses in the subsequent treatment cycles 
      ranged between 250 and 1,000 U. During open-label treatment, all treatment cycles 
      resulted in improvements in mean Toronto Western Spasmodic Torticollis Rating 
      Scale (TWSTRS) total scores. However, increasing the dose of Dysport above the 
      initial 500 U dose was not observed to result in an incremental improvement in 
      response as measured by the TWSTRS. No individual patient characteristic was 
      found to reliably predict the use of higher doses at each treatment cycle. 
      Dysport was generally well tolerated with no major differences in the incidence 
      of adverse events (AEs) observed with different doses. Dysphagia was considered 
      an AE of special interest and dysphagia data from the open-label studies were 
      combined with two Phase II studies. Analysis of this enhanced database indicates 
      that unilateral injections of >150 U into the sternocleidomastoid muscle is 
      associated with a higher dysphagia risk. Thus, limiting the dose in the 
      sternocleidomastoid may help reduce the incidence of dysphagia.
FAU - Hauser, Robert A
AU  - Hauser RA
AD  - Parkinson's Disease and Movement Disorders Center, NPF Center of Excellence, Byrd 
      Institute, University of South Florida, 4001 E. Fletcher Ave, 6th Floor, Tampa, 
      FL 33613, USA. rhauser@health.usf.edu
FAU - Truong, Daniel
AU  - Truong D
FAU - Hubble, Jean
AU  - Hubble J
FAU - Coleman, Chandra
AU  - Coleman C
FAU - Beffy, Jean-Luc
AU  - Beffy JL
FAU - Chang, Stephen
AU  - Chang S
FAU - Picaut, Philippe
AU  - Picaut P
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20120810
PL  - Austria
TA  - J Neural Transm (Vienna)
JT  - Journal of neural transmission (Vienna, Austria : 1996)
JID - 9702341
RN  - 0 (Neuromuscular Agents)
RN  - EC 3.4.24.69 (Botulinum Toxins, Type A)
RN  - EC 3.4.24.69 (abobotulinumtoxinA)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Botulinum Toxins, Type A/administration & dosage/*therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neuromuscular Agents/administration & dosage/*therapeutic use
MH  - Severity of Illness Index
MH  - Torticollis/*drug therapy
MH  - Treatment Outcome
EDAT- 2012/08/11 06:00
MHDA- 2013/07/20 06:00
CRDT- 2012/08/11 06:00
PHST- 2012/06/15 00:00 [received]
PHST- 2012/07/21 00:00 [accepted]
PHST- 2012/08/11 06:00 [entrez]
PHST- 2012/08/11 06:00 [pubmed]
PHST- 2013/07/20 06:00 [medline]
AID - 10.1007/s00702-012-0872-1 [doi]
PST - ppublish
SO  - J Neural Transm (Vienna). 2013 Feb;120(2):299-307. doi: 
      10.1007/s00702-012-0872-1. Epub 2012 Aug 10.