Biological activity of two botulinum toxin type A complexes (Dysport and Botox) in volunteers: a double-blind, randomized, dose-ranging study.
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.
Klinik für Neurologie, HELIOS Klinikum, Pieskower Strasse 33, Bad Saarow, Germany. kai.wohlfarth@helios-kliniken.de
K
K
Wohlfarth
I
I
Schwandt
F
F
Wegner
T
T
Jürgens
G
G
Gelbrich
A
A
Wagner
U
U
Bogdahn
W
W
Schulte-Mattler
D000200:Action Potentials / Q000187:drug effects / Q000502:physiology; D000293:Adolescent; D000328:Adult; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D002626:Chemistry, Pharmaceutical; D004058:Diffusion; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018482:Muscle, Skeletal / Q000187:drug effects / Q000502:physiology; D009928:Organ Specificity / Q000187:drug effects / Q000502:physiology; D011446:Prospective Studies; D055815:Young Adult
D004338:Drug Combinations; D019274:Botulinum Toxins, Type A