Cargando…
Dysport and Botox at a Ratio of 2.5:1 Units in Cervical Dystonia: A Double-Blind, Randomized Study
We aimed to compare Dysport (abobotulinumtoxinA, Ipsen Biopharm, Slough, UK) and Botox (onabotulinumtoxinA, Allergan, Irvine, CA, USA) at a 2.5:1 ratio in the treatment of cervical dystonia (CD). A Dysport/Botox ratio of lower than 3:1 was suggested as a more appropriate conversion ratio, considerin...
Autores principales: | , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BlackWell Publishing Ltd
2015
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4359015/ https://www.ncbi.nlm.nih.gov/pubmed/25476727 http://dx.doi.org/10.1002/mds.26085 |
_version_ | 1782361329333436416 |
---|---|
author | Yun, Ji Young Kim, Jae Woo Kim, Hee-Tae Chung, Sun Ju Kim, Jong-Min Cho, Jin Whan Lee, Jee-Young Lee, Ha Neul You, Sooyeoun Oh, Eungseok Jeong, Heejeong Kim, Young Eun Kim, Han-Joon Lee, Won Yong Jeon, Beom S |
author_facet | Yun, Ji Young Kim, Jae Woo Kim, Hee-Tae Chung, Sun Ju Kim, Jong-Min Cho, Jin Whan Lee, Jee-Young Lee, Ha Neul You, Sooyeoun Oh, Eungseok Jeong, Heejeong Kim, Young Eun Kim, Han-Joon Lee, Won Yong Jeon, Beom S |
author_sort | Yun, Ji Young |
collection | PubMed |
description | We aimed to compare Dysport (abobotulinumtoxinA, Ipsen Biopharm, Slough, UK) and Botox (onabotulinumtoxinA, Allergan, Irvine, CA, USA) at a 2.5:1 ratio in the treatment of cervical dystonia (CD). A Dysport/Botox ratio of lower than 3:1 was suggested as a more appropriate conversion ratio, considering its higher efficacy and more frequent incidence of adverse effects not only in the treatment of CD but also in other focal movement disorders. A randomized, double-blind, multicenter, non-inferiority, two-period crossover study was done in CD, with a duration of at least 18 months. Patients were randomly assigned to treatment for the first period with Dysport or Botox, and they were followed up for 16 weeks after the injection. After a 4-week washout period, they were switched to the other formulation and then followed up for 16 weeks. The primary outcome was the changes in the Tsui scale between the baseline value and that at 1 month after each injection. A total of 103 patients were enrolled, and 94 completed the study. Mean changes in the Tsui scale between baseline and 4 weeks after each injection tended to favor Botox; however, this was not statistically significant (4.0 ± 3.9 points for the Dysport treatment vs. 4.8 ± 4.1 points for Botox; 95% confidence interval, −0.1-1.7; P = 0.091). The mean change of the Toronto western spasmodic torticollis rating scale score, the proportion of improvement in clinical global impression and patient global impression, and the incidences of adverse events were not significantly different between the two treatments. With regard to safety and efficacy, Dysport was not inferior to Botox in patients with CD at a conversion factor of 2.5:1. [http//clinicaltrial.gov: NCT00950664] © The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society. |
format | Online Article Text |
id | pubmed-4359015 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | BlackWell Publishing Ltd |
record_format | MEDLINE/PubMed |
spelling | pubmed-43590152015-03-19 Dysport and Botox at a Ratio of 2.5:1 Units in Cervical Dystonia: A Double-Blind, Randomized Study Yun, Ji Young Kim, Jae Woo Kim, Hee-Tae Chung, Sun Ju Kim, Jong-Min Cho, Jin Whan Lee, Jee-Young Lee, Ha Neul You, Sooyeoun Oh, Eungseok Jeong, Heejeong Kim, Young Eun Kim, Han-Joon Lee, Won Yong Jeon, Beom S Mov Disord Research Articles We aimed to compare Dysport (abobotulinumtoxinA, Ipsen Biopharm, Slough, UK) and Botox (onabotulinumtoxinA, Allergan, Irvine, CA, USA) at a 2.5:1 ratio in the treatment of cervical dystonia (CD). A Dysport/Botox ratio of lower than 3:1 was suggested as a more appropriate conversion ratio, considering its higher efficacy and more frequent incidence of adverse effects not only in the treatment of CD but also in other focal movement disorders. A randomized, double-blind, multicenter, non-inferiority, two-period crossover study was done in CD, with a duration of at least 18 months. Patients were randomly assigned to treatment for the first period with Dysport or Botox, and they were followed up for 16 weeks after the injection. After a 4-week washout period, they were switched to the other formulation and then followed up for 16 weeks. The primary outcome was the changes in the Tsui scale between the baseline value and that at 1 month after each injection. A total of 103 patients were enrolled, and 94 completed the study. Mean changes in the Tsui scale between baseline and 4 weeks after each injection tended to favor Botox; however, this was not statistically significant (4.0 ± 3.9 points for the Dysport treatment vs. 4.8 ± 4.1 points for Botox; 95% confidence interval, −0.1-1.7; P = 0.091). The mean change of the Toronto western spasmodic torticollis rating scale score, the proportion of improvement in clinical global impression and patient global impression, and the incidences of adverse events were not significantly different between the two treatments. With regard to safety and efficacy, Dysport was not inferior to Botox in patients with CD at a conversion factor of 2.5:1. [http//clinicaltrial.gov: NCT00950664] © The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society. BlackWell Publishing Ltd 2015-02 2014-12-05 /pmc/articles/PMC4359015/ /pubmed/25476727 http://dx.doi.org/10.1002/mds.26085 Text en © 2014 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society. http://creativecommons.org/licenses/by/3.0/ This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Research Articles Yun, Ji Young Kim, Jae Woo Kim, Hee-Tae Chung, Sun Ju Kim, Jong-Min Cho, Jin Whan Lee, Jee-Young Lee, Ha Neul You, Sooyeoun Oh, Eungseok Jeong, Heejeong Kim, Young Eun Kim, Han-Joon Lee, Won Yong Jeon, Beom S Dysport and Botox at a Ratio of 2.5:1 Units in Cervical Dystonia: A Double-Blind, Randomized Study |
title | Dysport and Botox at a Ratio of 2.5:1 Units in Cervical Dystonia: A Double-Blind, Randomized Study |
title_full | Dysport and Botox at a Ratio of 2.5:1 Units in Cervical Dystonia: A Double-Blind, Randomized Study |
title_fullStr | Dysport and Botox at a Ratio of 2.5:1 Units in Cervical Dystonia: A Double-Blind, Randomized Study |
title_full_unstemmed | Dysport and Botox at a Ratio of 2.5:1 Units in Cervical Dystonia: A Double-Blind, Randomized Study |
title_short | Dysport and Botox at a Ratio of 2.5:1 Units in Cervical Dystonia: A Double-Blind, Randomized Study |
title_sort | dysport and botox at a ratio of 2.5:1 units in cervical dystonia: a double-blind, randomized study |
topic | Research Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4359015/ https://www.ncbi.nlm.nih.gov/pubmed/25476727 http://dx.doi.org/10.1002/mds.26085 |
work_keys_str_mv | AT yunjiyoung dysportandbotoxataratioof251unitsincervicaldystoniaadoubleblindrandomizedstudy AT kimjaewoo dysportandbotoxataratioof251unitsincervicaldystoniaadoubleblindrandomizedstudy AT kimheetae dysportandbotoxataratioof251unitsincervicaldystoniaadoubleblindrandomizedstudy AT chungsunju dysportandbotoxataratioof251unitsincervicaldystoniaadoubleblindrandomizedstudy AT kimjongmin dysportandbotoxataratioof251unitsincervicaldystoniaadoubleblindrandomizedstudy AT chojinwhan dysportandbotoxataratioof251unitsincervicaldystoniaadoubleblindrandomizedstudy AT leejeeyoung dysportandbotoxataratioof251unitsincervicaldystoniaadoubleblindrandomizedstudy AT leehaneul dysportandbotoxataratioof251unitsincervicaldystoniaadoubleblindrandomizedstudy AT yousooyeoun dysportandbotoxataratioof251unitsincervicaldystoniaadoubleblindrandomizedstudy AT oheungseok dysportandbotoxataratioof251unitsincervicaldystoniaadoubleblindrandomizedstudy AT jeongheejeong dysportandbotoxataratioof251unitsincervicaldystoniaadoubleblindrandomizedstudy AT kimyoungeun dysportandbotoxataratioof251unitsincervicaldystoniaadoubleblindrandomizedstudy AT kimhanjoon dysportandbotoxataratioof251unitsincervicaldystoniaadoubleblindrandomizedstudy AT leewonyong dysportandbotoxataratioof251unitsincervicaldystoniaadoubleblindrandomizedstudy AT jeonbeoms dysportandbotoxataratioof251unitsincervicaldystoniaadoubleblindrandomizedstudy |