Efficacy and safety of botulinum type A toxin (Dysport) in cervical dystonia: Results of the first US randomized, double‐blind, placebo‐controlled study
Identifieur interne : 000540 ( Istex/Curation ); précédent : 000539; suivant : 000541Efficacy and safety of botulinum type A toxin (Dysport) in cervical dystonia: Results of the first US randomized, double‐blind, placebo‐controlled study
Auteurs : Daniel Truong [États-Unis] ; Drake D. Duane [États-Unis] ; Joseph Jankovic [États-Unis] ; Carlos Singer [États-Unis] ; Lauren C. Seeberger [États-Unis] ; Cynthia L. Comella [États-Unis] ; Mark F. Lew [États-Unis] ; Robert L. Rodnitzky [États-Unis] ; Fabio O. Danisi [États-Unis] ; James P. Sutton [États-Unis] ; P. David Charles [États-Unis] ; Robert A. Hauser [États-Unis] ; Geoffrey L. Sheean [États-Unis]Source :
- Movement Disorders [ 0885-3185 ] ; 2005-07.
English descriptors
Abstract
Botulinum toxin type A (Dysport) has been shown in European studies to be a safe and effective treatment for cervical dystonia. This multicenter, double‐blind, randomized, controlled trial assessed the safety and efficacy of Dysport in cervical dystonia patients in the United States. Eighty patients were randomly assigned to receive one treatment with Dysport (500 units) or placebo. Participants were followed up for 4 to 20 weeks, until they needed further treatment. They were assessed at baseline and weeks 2, 4, 8, 12, 16, and 20 after treatment. Dysport was significantly more efficacious than placebo at weeks 4, 8, and 12 as assessed by the Toronto Western Spasmodic Torticollis Rating Scale (10‐point vs. 3.8‐point reduction in total score, respectively, at week 4; P ≤ 0.013). Of participants in the Dysport group, 38% showed positive treatment response, compared to 16% in the placebo group (95% confidence interval, 0.02–0.41). The median duration of response to Dysport was 18.5 weeks. Side effects were generally similar in the two treatment groups; only blurred vision and weakness occurred significantly more often with Dysport. No participants in the Dysport group converted from negative to positive antibodies after treatment. These results confirm previous reports that Dysport (500 units) is safe, effective, and well‐tolerated in patients with cervical dystonia. © 2005 Movement Disorder Society
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DOI: 10.1002/mds.20403
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Sheean</name><affiliation wicri:level="1"><mods:affiliation>University of California, San Diego, California, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of California, San Diego, California</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:785AEE453336E9A6EC95C5F114B38ED80E086F39</idno><date when="2005" year="2005">2005</date><idno type="doi">10.1002/mds.20403</idno><idno type="url">https://api.istex.fr/document/785AEE453336E9A6EC95C5F114B38ED80E086F39/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">000540</idno><idno type="wicri:Area/Istex/Curation">000540</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">Efficacy and safety of botulinum type A toxin (Dysport) in cervical dystonia: Results of the first US randomized, double‐blind, placebo‐controlled study</title><author><name sortKey="Truong, Daniel" sort="Truong, Daniel" uniqKey="Truong D" first="Daniel" last="Truong">Daniel Truong</name><affiliation wicri:level="1"><mods:affiliation>The Parkinson's and Movement Disorders Institute, Fountain Valley, California, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>The Parkinson's and Movement Disorders Institute, Fountain Valley, California</wicri:regionArea></affiliation></author><author><name sortKey="Duane, Drake D" sort="Duane, Drake D" uniqKey="Duane D" first="Drake D." last="Duane">Drake D. Duane</name><affiliation wicri:level="1"><mods:affiliation>Arizona Dystonia Institute, Scottsdale, Arizona, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Arizona Dystonia Institute, Scottsdale, Arizona</wicri:regionArea></affiliation></author><author><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name><affiliation wicri:level="1"><mods:affiliation>Baylor College of Medicine, Houston, Texas, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Baylor College of Medicine, Houston, Texas</wicri:regionArea></affiliation></author><author><name sortKey="Singer, Carlos" sort="Singer, Carlos" uniqKey="Singer C" first="Carlos" last="Singer">Carlos Singer</name><affiliation wicri:level="1"><mods:affiliation>University of Miami School of Medicine, Miami, Florida, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Miami School of Medicine, Miami, Florida</wicri:regionArea></affiliation></author><author><name sortKey="Seeberger, Lauren C" sort="Seeberger, Lauren C" uniqKey="Seeberger L" first="Lauren C." last="Seeberger">Lauren C. 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Lew</name><affiliation wicri:level="1"><mods:affiliation>University of Southern California, Los Angeles, California, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Southern California, Los Angeles, California</wicri:regionArea></affiliation></author><author><name sortKey="Rodnitzky, Robert L" sort="Rodnitzky, Robert L" uniqKey="Rodnitzky R" first="Robert L." last="Rodnitzky">Robert L. Rodnitzky</name><affiliation wicri:level="1"><mods:affiliation>University of Iowa, Iowa City, Iowa, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Iowa, Iowa City, Iowa</wicri:regionArea></affiliation></author><author><name sortKey="Danisi, Fabio O" sort="Danisi, Fabio O" uniqKey="Danisi F" first="Fabio O." last="Danisi">Fabio O. Danisi</name><affiliation wicri:level="1"><mods:affiliation>Mount Sinai Medical Center, New York, New York, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Mount Sinai Medical Center, New York, New York</wicri:regionArea></affiliation></author><author><name sortKey="Sutton, James P" sort="Sutton, James P" uniqKey="Sutton J" first="James P." last="Sutton">James P. Sutton</name><affiliation wicri:level="1"><mods:affiliation>Neurological Research Institute, Encino, California, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Neurological Research Institute, Encino, California</wicri:regionArea></affiliation></author><author><name sortKey="Charles, P David" sort="Charles, P David" uniqKey="Charles P" first="P. David" last="Charles">P. David Charles</name><affiliation wicri:level="1"><mods:affiliation>Vanderbilt University, Nashville, Tennessee, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Vanderbilt University, Nashville, Tennessee</wicri:regionArea></affiliation></author><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A." last="Hauser">Robert A. Hauser</name><affiliation wicri:level="1"><mods:affiliation>University of South Florida, Tampa, Florida, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of South Florida, Tampa, Florida</wicri:regionArea></affiliation></author><author><name sortKey="Sheean, Geoffrey L" sort="Sheean, Geoffrey L" uniqKey="Sheean G" first="Geoffrey L." last="Sheean">Geoffrey L. Sheean</name><affiliation wicri:level="1"><mods:affiliation>University of California, San Diego, California, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of California, San Diego, California</wicri:regionArea></affiliation></author></analytic><monogr></monogr><series><title level="j">Movement Disorders</title><title level="j" type="sub">Official Journal of the Movement Disorder Society</title><title level="j" type="abbrev">Mov. Disord.</title><idno type="ISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2005-07">2005-07</date><biblScope unit="vol">20</biblScope><biblScope unit="issue">7</biblScope><biblScope unit="page" from="783">783</biblScope><biblScope unit="page" to="791">791</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">785AEE453336E9A6EC95C5F114B38ED80E086F39</idno><idno type="DOI">10.1002/mds.20403</idno><idno type="ArticleID">MDS20403</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Dysport</term><term>botulinum toxin</term><term>cervical dystonia</term><term>clinical trial</term><term>spasmodic torticollis</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Botulinum toxin type A (Dysport) has been shown in European studies to be a safe and effective treatment for cervical dystonia. This multicenter, double‐blind, randomized, controlled trial assessed the safety and efficacy of Dysport in cervical dystonia patients in the United States. Eighty patients were randomly assigned to receive one treatment with Dysport (500 units) or placebo. Participants were followed up for 4 to 20 weeks, until they needed further treatment. They were assessed at baseline and weeks 2, 4, 8, 12, 16, and 20 after treatment. Dysport was significantly more efficacious than placebo at weeks 4, 8, and 12 as assessed by the Toronto Western Spasmodic Torticollis Rating Scale (10‐point vs. 3.8‐point reduction in total score, respectively, at week 4; P ≤ 0.013). Of participants in the Dysport group, 38% showed positive treatment response, compared to 16% in the placebo group (95% confidence interval, 0.02–0.41). The median duration of response to Dysport was 18.5 weeks. Side effects were generally similar in the two treatment groups; only blurred vision and weakness occurred significantly more often with Dysport. No participants in the Dysport group converted from negative to positive antibodies after treatment. These results confirm previous reports that Dysport (500 units) is safe, effective, and well‐tolerated in patients with cervical dystonia. © 2005 Movement Disorder Society</div></front></TEI></record>Pour manipuler ce document sous Unix (Dilib)
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