Biological activity of two botulinum toxin type A complexes (Dysport and Botox) in volunteers: a double-blind, randomized, dose-ranging study.
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Biological activity of two botulinum toxin type A complexes (Dysport and Botox) in volunteers: a double-blind, randomized, dose-ranging study. / Wohlfarth, K; Schwandt, I; Wegner, F; Jürgens, Tim; Gelbrich, G; Wagner, A; Bogdahn, U; Schulte-Mattler, W.
in: J NEUROL, Jahrgang 255, Nr. 12, 12, 2008, S. 1932-1939.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Biological activity of two botulinum toxin type A complexes (Dysport and Botox) in volunteers: a double-blind, randomized, dose-ranging study.
AU - Wohlfarth, K
AU - Schwandt, I
AU - Wegner, F
AU - Jürgens, Tim
AU - Gelbrich, G
AU - Wagner, A
AU - Bogdahn, U
AU - Schulte-Mattler, W
PY - 2008
Y1 - 2008
N2 - Despite extensive clinical experience and published data regarding botulinum toxin, questions remain about the clinical substitution of one botulinum toxin formulation for another. In the case of Dysport and Botox, dose-equivalence ratios ranging from 1:1 to 6:1 (Dysport:Botox) have been advocated. This dose-ranging, electroneurographic study investigated the dose equivalence, diffusion characteristics (spread) and safety of these two type-A toxins in 79 volunteers. Dysport and Botox caused significant and similar reductions in compound muscle action potential (CMAP) amplitude in the target muscle (extensor digitorum brevis, EDB) 2 weeks after injection, with effects persisting to the 12-week timepoint. For both products, the reduction in amplitude was increased with increasing doses and with increasing concentration. The effects of toxin on neighbouring muscles were much smaller and of a shorter duration than those on the target muscle, implying a modest spread of toxin. Unlike the target muscle, the effects were greater with the higher volume, suggesting this volume led to greater diffusion from the EDB. No adverse events were reported. Statistical modelling with CMAP amplitude data from the target muscle gave a bioequivalence of 1.57 units of Dysport:1 unit of Botox (95 % CI: 0.77-3.20 units). The data indicate that a dose-equivalence ratio of 3:1 was within the statistical error limits, but ratios over 3:1 are too high.
AB - Despite extensive clinical experience and published data regarding botulinum toxin, questions remain about the clinical substitution of one botulinum toxin formulation for another. In the case of Dysport and Botox, dose-equivalence ratios ranging from 1:1 to 6:1 (Dysport:Botox) have been advocated. This dose-ranging, electroneurographic study investigated the dose equivalence, diffusion characteristics (spread) and safety of these two type-A toxins in 79 volunteers. Dysport and Botox caused significant and similar reductions in compound muscle action potential (CMAP) amplitude in the target muscle (extensor digitorum brevis, EDB) 2 weeks after injection, with effects persisting to the 12-week timepoint. For both products, the reduction in amplitude was increased with increasing doses and with increasing concentration. The effects of toxin on neighbouring muscles were much smaller and of a shorter duration than those on the target muscle, implying a modest spread of toxin. Unlike the target muscle, the effects were greater with the higher volume, suggesting this volume led to greater diffusion from the EDB. No adverse events were reported. Statistical modelling with CMAP amplitude data from the target muscle gave a bioequivalence of 1.57 units of Dysport:1 unit of Botox (95 % CI: 0.77-3.20 units). The data indicate that a dose-equivalence ratio of 3:1 was within the statistical error limits, but ratios over 3:1 are too high.
KW - Adult
KW - Humans
KW - Male
KW - Female
KW - Middle Aged
KW - Adolescent
KW - Young Adult
KW - Prospective Studies
KW - Double-Blind Method
KW - Dose-Response Relationship, Drug
KW - Drug Combinations
KW - Diffusion
KW - Chemistry, Pharmaceutical
KW - Action Potentials/drug effects/physiology
KW - Botulinum Toxins, Type A/administration & dosage/adverse effects/pharmacokinetics
KW - Muscle, Skeletal/drug effects/physiology
KW - Organ Specificity/drug effects/physiology
KW - Adult
KW - Humans
KW - Male
KW - Female
KW - Middle Aged
KW - Adolescent
KW - Young Adult
KW - Prospective Studies
KW - Double-Blind Method
KW - Dose-Response Relationship, Drug
KW - Drug Combinations
KW - Diffusion
KW - Chemistry, Pharmaceutical
KW - Action Potentials/drug effects/physiology
KW - Botulinum Toxins, Type A/administration & dosage/adverse effects/pharmacokinetics
KW - Muscle, Skeletal/drug effects/physiology
KW - Organ Specificity/drug effects/physiology
M3 - SCORING: Journal article
VL - 255
SP - 1932
EP - 1939
JO - J NEUROL
JF - J NEUROL
SN - 0340-5354
IS - 12
M1 - 12
ER -
