Botulinum toxin type B vs. type A in toxin-naïve patients with cervical dystonia: Randomized, double-blind, noninferiority trial.
Identifieur interne : 001F79 ( Ncbi/Checkpoint ); précédent : 001F78; suivant : 001F80Botulinum toxin type B vs. type A in toxin-naïve patients with cervical dystonia: Randomized, double-blind, noninferiority trial.
Auteurs : Eric J. Pappert [États-Unis] ; Terry GermansonSource :
- Movement disorders : official journal of the Movement Disorder Society [ 1531-8257 ] ; 2008.
English descriptors
- KwdEn :
- Botulinum Toxins (adverse effects), Botulinum Toxins (therapeutic use), Botulinum Toxins, Type A (adverse effects), Botulinum Toxins, Type A (therapeutic use), Disability Evaluation, Double-Blind Method, Female, Humans, Injections, Male, Middle Aged, Neuromuscular Agents (adverse effects), Neuromuscular Agents (therapeutic use), Pain (etiology), Pain Measurement, Severity of Illness Index, Torticollis (complications), Torticollis (diagnosis), Torticollis (drug therapy), Treatment Outcome, Xerostomia (chemically induced), Xerostomia (epidemiology).
- MESH :
- chemical , adverse effects : Botulinum Toxins, Botulinum Toxins, Type A, Neuromuscular Agents.
- chemical , therapeutic use : Botulinum Toxins, Botulinum Toxins, Type A, Neuromuscular Agents.
- chemically induced : Xerostomia.
- complications : Torticollis.
- diagnosis : Torticollis.
- drug therapy : Torticollis.
- epidemiology : Xerostomia.
- etiology : Pain.
- Disability Evaluation, Double-Blind Method, Female, Humans, Injections, Male, Middle Aged, Pain Measurement, Severity of Illness Index, Treatment Outcome.
Abstract
The objective of this study was to compare efficacy, safety, and duration of botulinum toxin type A (BoNT-A) and type B (BoNT-B) in toxin-naïve cervical dystonia (CD) subjects. BoNT-naïve CD subjects were randomized to BoNT-A or BoNT-B and evaluated in a double-blind trial at baseline and every 4-weeks following one treatment. The primary measure was the change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) from baseline to week 4 post-injection. Secondary measures included change in TWSTRS-subscale scores, pain, global impressions, and duration of response and safety assessments. The study was designed as a noninferiority trial of BoNT-B to BoNT-A. 111 subjects were randomized (55 BoNT-A; 56 BoNT-B). Improvement in TWSTRS-total scores 4 weeks after BoNT-B was noninferior to BoNT-A (adjusted means 11.0 (SE 1.2) and 8.8 (SE 1.2), respectively; per-protocol-population (PPP)). The median duration of effect of BoNT-A and BoNT-B was not different (13.1 vs. 13.7 weeks, respectively; P-value = 0.833; PPP). There were no significant differences in the occurrence of injection site pain and dysphagia. Mild dry mouth was more frequent with BoNT-B but there were no differences for moderate/severe dry mouth. In this study, both BoNT-A and B were shown to be effective and safe for the treatment of toxin-naive CD subjects.
DOI: 10.1002/mds.21724
PubMed: 18098274
Affiliations:
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Pappert</name><affiliation wicri:level="2"><nlm:affiliation>Solstice Neurosciences, Inc, Malvern, Pennsylvania, USA. pappert@uthscsa.edu</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Solstice Neurosciences, Inc, Malvern, Pennsylvania</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Germanson, Terry" sort="Germanson, Terry" uniqKey="Germanson T" first="Terry" last="Germanson">Terry Germanson</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2008">2008</date><idno type="doi">10.1002/mds.21724</idno><idno type="RBID">pubmed:18098274</idno><idno type="pmid">18098274</idno><idno type="wicri:Area/PubMed/Corpus">002380</idno><idno type="wicri:Area/PubMed/Curation">002380</idno><idno type="wicri:Area/PubMed/Checkpoint">002405</idno><idno type="wicri:Area/Ncbi/Merge">001F79</idno><idno type="wicri:Area/Ncbi/Curation">001F79</idno><idno type="wicri:Area/Ncbi/Checkpoint">001F79</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Botulinum toxin type B vs. type A in toxin-naïve patients with cervical dystonia: Randomized, double-blind, noninferiority trial.</title><author><name sortKey="Pappert, Eric J" sort="Pappert, Eric J" uniqKey="Pappert E" first="Eric J" last="Pappert">Eric J. Pappert</name><affiliation wicri:level="2"><nlm:affiliation>Solstice Neurosciences, Inc, Malvern, Pennsylvania, USA. pappert@uthscsa.edu</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Solstice Neurosciences, Inc, Malvern, Pennsylvania</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Germanson, Terry" sort="Germanson, Terry" uniqKey="Germanson T" first="Terry" last="Germanson">Terry Germanson</name></author></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="eISSN">1531-8257</idno><imprint><date when="2008" type="published">2008</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Botulinum Toxins (adverse effects)</term><term>Botulinum Toxins (therapeutic use)</term><term>Botulinum Toxins, Type A (adverse effects)</term><term>Botulinum Toxins, Type A (therapeutic use)</term><term>Disability Evaluation</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Injections</term><term>Male</term><term>Middle Aged</term><term>Neuromuscular Agents (adverse effects)</term><term>Neuromuscular Agents (therapeutic use)</term><term>Pain (etiology)</term><term>Pain Measurement</term><term>Severity of Illness Index</term><term>Torticollis (complications)</term><term>Torticollis (diagnosis)</term><term>Torticollis (drug therapy)</term><term>Treatment Outcome</term><term>Xerostomia (chemically induced)</term><term>Xerostomia (epidemiology)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Botulinum Toxins</term><term>Botulinum Toxins, Type A</term><term>Neuromuscular Agents</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Botulinum Toxins</term><term>Botulinum Toxins, Type A</term><term>Neuromuscular Agents</term></keywords><keywords scheme="MESH" qualifier="chemically induced" xml:lang="en"><term>Xerostomia</term></keywords><keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Torticollis</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Torticollis</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Torticollis</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Xerostomia</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Pain</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Disability Evaluation</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Injections</term><term>Male</term><term>Middle Aged</term><term>Pain Measurement</term><term>Severity of Illness Index</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The objective of this study was to compare efficacy, safety, and duration of botulinum toxin type A (BoNT-A) and type B (BoNT-B) in toxin-naïve cervical dystonia (CD) subjects. BoNT-naïve CD subjects were randomized to BoNT-A or BoNT-B and evaluated in a double-blind trial at baseline and every 4-weeks following one treatment. The primary measure was the change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) from baseline to week 4 post-injection. Secondary measures included change in TWSTRS-subscale scores, pain, global impressions, and duration of response and safety assessments. The study was designed as a noninferiority trial of BoNT-B to BoNT-A. 111 subjects were randomized (55 BoNT-A; 56 BoNT-B). Improvement in TWSTRS-total scores 4 weeks after BoNT-B was noninferior to BoNT-A (adjusted means 11.0 (SE 1.2) and 8.8 (SE 1.2), respectively; per-protocol-population (PPP)). The median duration of effect of BoNT-A and BoNT-B was not different (13.1 vs. 13.7 weeks, respectively; P-value = 0.833; PPP). There were no significant differences in the occurrence of injection site pain and dysphagia. Mild dry mouth was more frequent with BoNT-B but there were no differences for moderate/severe dry mouth. In this study, both BoNT-A and B were shown to be effective and safe for the treatment of toxin-naive CD subjects.</div></front></TEI><affiliations><list><country><li>États-Unis</li></country><region><li>Pennsylvanie</li></region></list><tree><noCountry><name sortKey="Germanson, Terry" sort="Germanson, Terry" uniqKey="Germanson T" first="Terry" last="Germanson">Terry Germanson</name></noCountry><country name="États-Unis"><region name="Pennsylvanie"><name sortKey="Pappert, Eric J" sort="Pappert, Eric J" uniqKey="Pappert E" first="Eric J" last="Pappert">Eric J. Pappert</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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