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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

Journal of Neurology volume 255, pages 1932–1939 (2008)Cite this article

An Erratum to this article was published on 02 July 2009

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® and Botox®, 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.

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Authors and Affiliations

  1. Klinik für Neurologie, HELIOS Klinikum, Pieskower Str. 33, 15526, Bad Saarow, Germany

    K. Wohlfarth MD, PhD

  2. Dept. of Neurology, University of Leipzig, Liebigstr. 22a, 04103, Leipzig, Germany

    K. Wohlfarth MD, PhD, I. Schwandt, F. Wegner MD & A. Wagner MD, PhD

  3. Dept. of Neurology, University of Regensburg, Franz-Josef-Strauss-Allee 11, 93053, Regensburg, Germany

    T. Jürgens MD, U. Bogdahn MD, PhD & W. Schulte-Mattler MD

  4. Coordination Center for Clinical Trials, Leipzig (KKSL), Haertelstr. 16–18, 04103, Leipzig, Germany

    G. Gelbrich PhD

Authors
  1. K. Wohlfarth MD, PhD
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  2. I. Schwandt
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  3. F. Wegner MD
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  4. T. Jürgens MD
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  6. A. Wagner MD, PhD
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  7. U. Bogdahn MD, PhD
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  8. W. Schulte-Mattler MD
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Correspondence to K. Wohlfarth MD, PhD.

Additional information

An erratum to this article is available at http://dx.doi.org/10.1007/s00415-009-5182-7.

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Wohlfarth, K., Schwandt, I., Wegner, F. et al. Biological activity of two botulinum toxin type A complexes (Dysport® and Botox®) in volunteers. J Neurol 255, 1932–1939 (2008). https://doi.org/10.1007/s00415-008-0031-7

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  • DOI: https://doi.org/10.1007/s00415-008-0031-7

Key words

  • botulinum toxin
  • Dysport
  • Botox
  • dose equivalence
  • randomized controlled trial