Botulinum toxin type B vs. type A in toxin‐naïve patients with cervical dystonia: Randomized, double‐blind, noninferiority trial
Identifieur interne : 002970 ( Main/Exploration ); précédent : 002969; suivant : 002971Botulinum 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 Germanson [Canada]Source :
- Movement Disorders [ 0885-3185 ] ; 2008-03-15.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
- Bontoxilysin, 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, Dystonia, Female, Human, Humans, Injections, Male, Middle Aged, Nervous system diseases, Neuromuscular Agents (adverse effects), Neuromuscular Agents (therapeutic use), Pain (etiology), Pain Measurement, Severity of Illness Index, Torticollis (complications), Torticollis (diagnosis), Torticollis (drug therapy), Toxin, Treatment Outcome, Xerostomia (chemically induced), Xerostomia (epidemiology), botulinum toxin type A, botulinum toxin type B, cervical dystonia, toxin‐naïve.
- 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. © 2007 Movement Disorder Society
Url:
DOI: 10.1002/mds.21724
Affiliations:
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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. © 2007 Movement Disorder Society</div></front></TEI><affiliations><list><country><li>Canada</li><li>États-Unis</li></country><region><li>Pennsylvanie</li><li>Texas</li></region></list><tree><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><name sortKey="Pappert, Eric J" sort="Pappert, Eric J" uniqKey="Pappert E" first="Eric J." last="Pappert">Eric J. Pappert</name></country><country name="Canada"><noRegion><name sortKey="Germanson, Terry" sort="Germanson, Terry" uniqKey="Germanson T" first="Terry" last="Germanson">Terry Germanson</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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