Wohlfarth, Kai and Schwandt, Imke and Wegner, Florian and Juergens, Tim and Gelbrich, Goetz and Wagner, Armin and Bogdahn, Ulrich and Schulte-Mattler, Wilhelm (2008) Biological activity of two botulinum toxin type A complexes (Dysport (R) and Botox (R)) in volunteers A double-blind, randomized, dose-ranging study. JOURNAL OF NEUROLOGY, 255 (12). pp. 1932-1939. ISSN 0340-5354, 1432-1459
Full text not available from this repository. (Request a copy)Abstract
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 (R) and Botox (R), doseequivalence 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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | CERVICAL DYSTONIA; RESPECTIVE POTENCIES; BLEPHAROSPASM; FORMULATIONS; CROSSOVER; botulinum toxin; Dysport; Botox; dose equivalence; randomized controlled trial |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Neurologie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 16 Oct 2020 10:47 |
| Last Modified: | 16 Oct 2020 10:47 |
| URI: | https://pred.uni-regensburg.de/id/eprint/29985 |
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