Dysport and Botox at a Ratio of 2.5:1 Units in Cervical Dystonia: A Double-Blind, Randomized Study
Identifieur interne : 000596 ( Main/Exploration ); précédent : 000595; suivant : 000597Dysport and Botox at a Ratio of 2.5:1 Units in Cervical Dystonia: A Double-Blind, Randomized Study
Auteurs : Ji Young Yun [Corée du Sud] ; Jae Woo Kim [Corée du Sud] ; Hee-Tae Kim [Corée du Sud] ; Sun Ju Chung [Corée du Sud] ; Jong-Min Kim [Corée du Sud] ; Jin Whan Cho [Corée du Sud] ; Jee-Young Lee [Corée du Sud] ; Ha Neul Lee [Corée du Sud] ; Sooyeoun You [Corée du Sud] ; Eungseok Oh [Corée du Sud] ; Heejeong Jeong [Corée du Sud] ; Young Eun Kim [Corée du Sud] ; Han-Joon Kim [Corée du Sud] ; Won Yong Lee [Corée du Sud] ; Beom S. Jeon [Corée du Sud]Source :
- Movement Disorders [ 0885-3185 ] ; 2014.
English descriptors
- KwdEn :
- Acetylcholine Release Inhibitors (therapeutic use), Adult, Aged, Botulinum Toxins, Type A (therapeutic use), Double-Blind Method, Drug Combinations, Female, Humans, Male, Middle Aged, Pain (etiology), Pain Measurement, Torticollis (complications), Torticollis (drug therapy), Treatment Outcome, Young Adult.
- MESH :
- chemical , therapeutic use : Acetylcholine Release Inhibitors, Botulinum Toxins, Type A.
- complications : Torticollis.
- drug therapy : Torticollis.
- etiology : Pain.
- Adult, Aged, Double-Blind Method, Drug Combinations, Female, Humans, Male, Middle Aged, Pain Measurement, Treatment Outcome, Young Adult.
Abstract
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;
Url:
DOI: 10.1002/mds.26085
PubMed: 25476727
PubMed Central: 4359015
Affiliations:
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Le document en format XML
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<author><name sortKey="Lee, Ha Neul" sort="Lee, Ha Neul" uniqKey="Lee H" first="Ha Neul" last="Lee">Ha Neul Lee</name>
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<author><name sortKey="You, Sooyeoun" sort="You, Sooyeoun" uniqKey="You S" first="Sooyeoun" last="You">Sooyeoun You</name>
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<author><name sortKey="Oh, Eungseok" sort="Oh, Eungseok" uniqKey="Oh E" first="Eungseok" last="Oh">Eungseok Oh</name>
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<author><name sortKey="Jeong, Heejeong" sort="Jeong, Heejeong" uniqKey="Jeong H" first="Heejeong" last="Jeong">Heejeong Jeong</name>
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<author><name sortKey="Kim, Young Eun" sort="Kim, Young Eun" uniqKey="Kim Y" first="Young Eun" last="Kim">Young Eun Kim</name>
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<author><name sortKey="Kim, Han Joon" sort="Kim, Han Joon" uniqKey="Kim H" first="Han-Joon" last="Kim">Han-Joon Kim</name>
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<author><name sortKey="Lee, Won Yong" sort="Lee, Won Yong" uniqKey="Lee W" first="Won Yong" last="Lee">Won Yong Lee</name>
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<author><name sortKey="Jeon, Beom S" sort="Jeon, Beom S" uniqKey="Jeon B" first="Beom S" last="Jeon">Beom S. Jeon</name>
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<term>Adult</term>
<term>Aged</term>
<term>Botulinum Toxins, Type A (therapeutic use)</term>
<term>Double-Blind Method</term>
<term>Drug Combinations</term>
<term>Female</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Pain (etiology)</term>
<term>Pain Measurement</term>
<term>Torticollis (complications)</term>
<term>Torticollis (drug therapy)</term>
<term>Treatment Outcome</term>
<term>Young Adult</term>
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<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Acetylcholine Release Inhibitors</term>
<term>Botulinum Toxins, Type A</term>
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<keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Torticollis</term>
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<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Torticollis</term>
</keywords>
<keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Pain</term>
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<keywords scheme="MESH" xml:lang="en"><term>Adult</term>
<term>Aged</term>
<term>Double-Blind Method</term>
<term>Drug Combinations</term>
<term>Female</term>
<term>Humans</term>
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<front><div type="abstract" xml:lang="en"><p>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; <italic>P</italic>
= 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. [<ext-link ext-link-type="uri" xlink:href="http//clinicaltrial.gov">http//clinicaltrial.gov</ext-link>
: NCT00950664] © The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.</p>
</div>
</front>
<back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Chan, J" uniqKey="Chan J">J Chan</name>
</author>
<author><name sortKey="Brin, Mf" uniqKey="Brin M">MF Brin</name>
</author>
<author><name sortKey="Fahn, S" uniqKey="Fahn S">S Fahn</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Simpson, Dm" uniqKey="Simpson D">DM Simpson</name>
</author>
<author><name sortKey="Blitzer, A" uniqKey="Blitzer A">A Blitzer</name>
</author>
<author><name sortKey="Brashear, A" uniqKey="Brashear A">A Brashear</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Ravenni, R" uniqKey="Ravenni R">R Ravenni</name>
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</TEI>
<affiliations><list><country><li>Corée du Sud</li>
</country>
</list>
<tree><country name="Corée du Sud"><noRegion><name sortKey="Yun, Ji Young" sort="Yun, Ji Young" uniqKey="Yun J" first="Ji Young" last="Yun">Ji Young Yun</name>
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<name sortKey="Chung, Sun Ju" sort="Chung, Sun Ju" uniqKey="Chung S" first="Sun Ju" last="Chung">Sun Ju Chung</name>
<name sortKey="Jeon, Beom S" sort="Jeon, Beom S" uniqKey="Jeon B" first="Beom S" last="Jeon">Beom S. Jeon</name>
<name sortKey="Jeong, Heejeong" sort="Jeong, Heejeong" uniqKey="Jeong H" first="Heejeong" last="Jeong">Heejeong Jeong</name>
<name sortKey="Kim, Han Joon" sort="Kim, Han Joon" uniqKey="Kim H" first="Han-Joon" last="Kim">Han-Joon Kim</name>
<name sortKey="Kim, Hee Tae" sort="Kim, Hee Tae" uniqKey="Kim H" first="Hee-Tae" last="Kim">Hee-Tae Kim</name>
<name sortKey="Kim, Jae Woo" sort="Kim, Jae Woo" uniqKey="Kim J" first="Jae Woo" last="Kim">Jae Woo Kim</name>
<name sortKey="Kim, Jong Min" sort="Kim, Jong Min" uniqKey="Kim J" first="Jong-Min" last="Kim">Jong-Min Kim</name>
<name sortKey="Kim, Young Eun" sort="Kim, Young Eun" uniqKey="Kim Y" first="Young Eun" last="Kim">Young Eun Kim</name>
<name sortKey="Lee, Ha Neul" sort="Lee, Ha Neul" uniqKey="Lee H" first="Ha Neul" last="Lee">Ha Neul Lee</name>
<name sortKey="Lee, Jee Young" sort="Lee, Jee Young" uniqKey="Lee J" first="Jee-Young" last="Lee">Jee-Young Lee</name>
<name sortKey="Lee, Won Yong" sort="Lee, Won Yong" uniqKey="Lee W" first="Won Yong" last="Lee">Won Yong Lee</name>
<name sortKey="Oh, Eungseok" sort="Oh, Eungseok" uniqKey="Oh E" first="Eungseok" last="Oh">Eungseok Oh</name>
<name sortKey="You, Sooyeoun" sort="You, Sooyeoun" uniqKey="You S" first="Sooyeoun" last="You">Sooyeoun You</name>
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