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 : 001177 ( Ncbi/Merge ); précédent : 001176; suivant : 001178Efficacy 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 ; Joseph Jankovic [États-Unis] ; Carlos Singer ; Lauren C. Seeberger ; Cynthia L. Comella ; Mark F. Lew ; Robert L. Rodnitzky ; Fabio O. Danisi ; James P. Sutton ; P David Charles ; Robert A. Hauser ; Geoffrey L. SheeanSource :
- Movement disorders : official journal of the Movement Disorder Society [ 0885-3185 ] ; 2005.
Descripteurs français
- Wicri :
- geographic : États-Unis.
English descriptors
- KwdEn :
- Adult, Aged, Antibody Formation, Botulinum Toxins, Type A (therapeutic use), Disability Evaluation, Dose-Response Relationship, Drug, Double-Blind Method, Drug Evaluation, Female, Follow-Up Studies, Humans, Male, Middle Aged, Neuromuscular Agents (therapeutic use), Pain Measurement (methods), Patient Satisfaction, Prospective Studies, Time Factors, Torticollis (drug therapy), Torticollis (immunology), Treatment Outcome, United States.
- MESH :
- chemical , therapeutic use : Botulinum Toxins, Type A, Neuromuscular Agents.
- geographic : United States.
- drug therapy : Torticollis.
- immunology : Torticollis.
- methods : Pain Measurement.
- Adult, Aged, Antibody Formation, Disability Evaluation, Dose-Response Relationship, Drug, Double-Blind Method, Drug Evaluation, Female, Follow-Up Studies, Humans, Male, Middle Aged, Patient Satisfaction, Prospective Studies, Time Factors, Treatment Outcome.
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 < or = 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.
DOI: 10.1002/mds.20403
PubMed: 15736159
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Duane</name></author><author><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name><affiliation><country>États-Unis</country><placeName><settlement type="city">Houston</settlement><region type="state">Texas</region></placeName><orgName type="university" n="3">Baylor College of Medicine</orgName></affiliation></author><author><name sortKey="Singer, Carlos" sort="Singer, Carlos" uniqKey="Singer C" first="Carlos" last="Singer">Carlos Singer</name></author><author><name sortKey="Seeberger, Lauren C" sort="Seeberger, Lauren C" uniqKey="Seeberger L" first="Lauren C" last="Seeberger">Lauren C. Seeberger</name></author><author><name sortKey="Comella, Cynthia L" sort="Comella, Cynthia L" uniqKey="Comella C" first="Cynthia L" last="Comella">Cynthia L. Comella</name></author><author><name sortKey="Lew, Mark F" sort="Lew, Mark F" uniqKey="Lew M" first="Mark F" last="Lew">Mark F. Lew</name></author><author><name sortKey="Rodnitzky, Robert L" sort="Rodnitzky, Robert L" uniqKey="Rodnitzky R" first="Robert L" last="Rodnitzky">Robert L. Rodnitzky</name></author><author><name sortKey="Danisi, Fabio O" sort="Danisi, Fabio O" uniqKey="Danisi F" first="Fabio O" last="Danisi">Fabio O. Danisi</name></author><author><name sortKey="Sutton, James P" sort="Sutton, James P" uniqKey="Sutton J" first="James P" last="Sutton">James P. Sutton</name></author><author><name sortKey="Charles, P David" sort="Charles, P David" uniqKey="Charles P" first="P David" last="Charles">P David Charles</name></author><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A" last="Hauser">Robert A. Hauser</name></author><author><name sortKey="Sheean, Geoffrey L" sort="Sheean, Geoffrey L" uniqKey="Sheean G" first="Geoffrey L" last="Sheean">Geoffrey L. 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Duane</name></author><author><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name><affiliation><country>États-Unis</country><placeName><settlement type="city">Houston</settlement><region type="state">Texas</region></placeName><orgName type="university" n="3">Baylor College of Medicine</orgName></affiliation></author><author><name sortKey="Singer, Carlos" sort="Singer, Carlos" uniqKey="Singer C" first="Carlos" last="Singer">Carlos Singer</name></author><author><name sortKey="Seeberger, Lauren C" sort="Seeberger, Lauren C" uniqKey="Seeberger L" first="Lauren C" last="Seeberger">Lauren C. Seeberger</name></author><author><name sortKey="Comella, Cynthia L" sort="Comella, Cynthia L" uniqKey="Comella C" first="Cynthia L" last="Comella">Cynthia L. Comella</name></author><author><name sortKey="Lew, Mark F" sort="Lew, Mark F" uniqKey="Lew M" first="Mark F" last="Lew">Mark F. Lew</name></author><author><name sortKey="Rodnitzky, Robert L" sort="Rodnitzky, Robert L" uniqKey="Rodnitzky R" first="Robert L" last="Rodnitzky">Robert L. Rodnitzky</name></author><author><name sortKey="Danisi, Fabio O" sort="Danisi, Fabio O" uniqKey="Danisi F" first="Fabio O" last="Danisi">Fabio O. Danisi</name></author><author><name sortKey="Sutton, James P" sort="Sutton, James P" uniqKey="Sutton J" first="James P" last="Sutton">James P. Sutton</name></author><author><name sortKey="Charles, P David" sort="Charles, P David" uniqKey="Charles P" first="P David" last="Charles">P David Charles</name></author><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A" last="Hauser">Robert A. Hauser</name></author><author><name sortKey="Sheean, Geoffrey L" sort="Sheean, Geoffrey L" uniqKey="Sheean G" first="Geoffrey L" last="Sheean">Geoffrey L. Sheean</name></author></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="ISSN">0885-3185</idno><imprint><date when="2005" type="published">2005</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Antibody Formation</term><term>Botulinum Toxins, Type A (therapeutic use)</term><term>Disability Evaluation</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Drug Evaluation</term><term>Female</term><term>Follow-Up Studies</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Neuromuscular Agents (therapeutic use)</term><term>Pain Measurement (methods)</term><term>Patient Satisfaction</term><term>Prospective Studies</term><term>Time Factors</term><term>Torticollis (drug therapy)</term><term>Torticollis (immunology)</term><term>Treatment Outcome</term><term>United States</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Botulinum Toxins, Type A</term><term>Neuromuscular Agents</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>United States</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Torticollis</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Torticollis</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Pain Measurement</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Antibody Formation</term><term>Disability Evaluation</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Drug Evaluation</term><term>Female</term><term>Follow-Up Studies</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Patient Satisfaction</term><term>Prospective Studies</term><term>Time Factors</term><term>Treatment Outcome</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>États-Unis</term></keywords></textClass></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 < or = 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.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">15736159</PMID><DateCreated><Year>2005</Year><Month>07</Month><Day>13</Day></DateCreated><DateCompleted><Year>2005</Year><Month>11</Month><Day>14</Day></DateCompleted><DateRevised><Year>2010</Year><Month>11</Month><Day>18</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Print">0885-3185</ISSN><JournalIssue CitedMedium="Print"><Volume>20</Volume><Issue>7</Issue><PubDate><Year>2005</Year><Month>Jul</Month></PubDate></JournalIssue><Title>Movement disorders : official journal of the Movement Disorder Society</Title><ISOAbbreviation>Mov. Disord.</ISOAbbreviation></Journal><ArticleTitle>Efficacy and safety of botulinum type A toxin (Dysport) in cervical dystonia: results of the first US randomized, double-blind, placebo-controlled study.</ArticleTitle><Pagination><MedlinePgn>783-91</MedlinePgn></Pagination><Abstract><AbstractText>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 < or = 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.</AbstractText><CopyrightInformation>Copyright 2005 Movement Disorder Society.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Truong</LastName><ForeName>Daniel</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>The Parkinson's and Movement Disorders Institute, Fountain Valley, California 92708, USA. dtruong@pmdi.org</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Duane</LastName><ForeName>Drake D</ForeName><Initials>DD</Initials></Author><Author ValidYN="Y"><LastName>Jankovic</LastName><ForeName>Joseph</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Singer</LastName><ForeName>Carlos</ForeName><Initials>C</Initials></Author><Author ValidYN="Y"><LastName>Seeberger</LastName><ForeName>Lauren C</ForeName><Initials>LC</Initials></Author><Author ValidYN="Y"><LastName>Comella</LastName><ForeName>Cynthia L</ForeName><Initials>CL</Initials></Author><Author ValidYN="Y"><LastName>Lew</LastName><ForeName>Mark F</ForeName><Initials>MF</Initials></Author><Author ValidYN="Y"><LastName>Rodnitzky</LastName><ForeName>Robert L</ForeName><Initials>RL</Initials></Author><Author ValidYN="Y"><LastName>Danisi</LastName><ForeName>Fabio O</ForeName><Initials>FO</Initials></Author><Author ValidYN="Y"><LastName>Sutton</LastName><ForeName>James P</ForeName><Initials>JP</Initials></Author><Author ValidYN="Y"><LastName>Charles</LastName><ForeName>P David</ForeName><Initials>PD</Initials></Author><Author ValidYN="Y"><LastName>Hauser</LastName><ForeName>Robert A</ForeName><Initials>RA</Initials></Author><Author ValidYN="Y"><LastName>Sheean</LastName><ForeName>Geoffrey L</ForeName><Initials>GL</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016430">Clinical Trial</PublicationType><PublicationType UI="D003160">Comparative Study</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Mov Disord</MedlineTA><NlmUniqueID>8610688</NlmUniqueID><ISSNLinking>0885-3185</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D009465">Neuromuscular Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>EC 3.4.24.69</RegistryNumber><NameOfSubstance UI="D019274">Botulinum Toxins, Type A</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000328">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000368">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000917">Antibody Formation</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D019274">Botulinum Toxins, Type A</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004185">Disability Evaluation</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004305">Dose-Response Relationship, Drug</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004311">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004341">Drug Evaluation</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005260">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005500">Follow-Up Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006801">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008297">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008875">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D009465">Neuromuscular Agents</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D010147">Pain Measurement</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000379">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D017060">Patient Satisfaction</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D011446">Prospective Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D013997">Time Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D014103">Torticollis</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000188">drug therapy</QualifierName><QualifierName MajorTopicYN="N" UI="Q000276">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="Y" UI="D016896">Treatment Outcome</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" Type="Geographic" UI="D014481">United States</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>2005</Year><Month>3</Month><Day>1</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2005</Year><Month>11</Month><Day>15</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2005</Year><Month>3</Month><Day>1</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="doi">10.1002/mds.20403</ArticleId><ArticleId IdType="pubmed">15736159</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>États-Unis</li></country><region><li>Texas</li></region><settlement><li>Houston</li></settlement><orgName><li>Baylor College of Medicine</li></orgName></list><tree><noCountry><name sortKey="Charles, P David" sort="Charles, P David" uniqKey="Charles P" first="P David" last="Charles">P David Charles</name><name sortKey="Comella, Cynthia L" sort="Comella, Cynthia L" uniqKey="Comella C" first="Cynthia L" last="Comella">Cynthia L. Comella</name><name sortKey="Danisi, Fabio O" sort="Danisi, Fabio O" uniqKey="Danisi F" first="Fabio O" last="Danisi">Fabio O. Danisi</name><name sortKey="Duane, Drake D" sort="Duane, Drake D" uniqKey="Duane D" first="Drake D" last="Duane">Drake D. Duane</name><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A" last="Hauser">Robert A. Hauser</name><name sortKey="Lew, Mark F" sort="Lew, Mark F" uniqKey="Lew M" first="Mark F" last="Lew">Mark F. Lew</name><name sortKey="Rodnitzky, Robert L" sort="Rodnitzky, Robert L" uniqKey="Rodnitzky R" first="Robert L" last="Rodnitzky">Robert L. Rodnitzky</name><name sortKey="Seeberger, Lauren C" sort="Seeberger, Lauren C" uniqKey="Seeberger L" first="Lauren C" last="Seeberger">Lauren C. Seeberger</name><name sortKey="Sheean, Geoffrey L" sort="Sheean, Geoffrey L" uniqKey="Sheean G" first="Geoffrey L" last="Sheean">Geoffrey L. Sheean</name><name sortKey="Singer, Carlos" sort="Singer, Carlos" uniqKey="Singer C" first="Carlos" last="Singer">Carlos Singer</name><name sortKey="Sutton, James P" sort="Sutton, James P" uniqKey="Sutton J" first="James P" last="Sutton">James P. Sutton</name></noCountry><country name="États-Unis"><noRegion><name sortKey="Truong, Daniel" sort="Truong, Daniel" uniqKey="Truong D" first="Daniel" last="Truong">Daniel Truong</name></noRegion><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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