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Shin, Jeon, Woo, and Kim: Clinical Comparability of Dysport and Botox in Essential Blepharospasm
Original Article

J Korean Ophthalmol Soc 2009;50(3):331-335.

Published online: 31 August 2009

DOI: https://doi.org/10.3341/jkos.2009.50.3.331

Clinical Comparability of Dysport and Botox in Essential Blepharospasm

Jae Ho Shin, MD1, Chan Jeon, MD2, Kyung In Woo, MD, PhD3, Yoon Duck Kim, MD, PhD3

1Department of Ophthalmology, East-West Neo Medical Center, KyungHee University College of Medicine, Seoul, Korea

2Department of Ophthalmology, HanKang Sacred Heart Hospital, Hallym University, College of Medicine, Seoul, Korea

3Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University College of Medicine, Seoul, Korea

Address reprint requests to Yoon Duck Kim, MD, PhD, Department of Ophthalmology, Samsung Medical Center, School of Medicine Sungkyunkwan University #50 Ilwon-dong, Gangnam-gu, Seoul 135-710, Korea Tel: 82-2-3410-3568, Fax: 82-2-3410-0074, E-mail: ydkimoph@skku.edu

Received 23 June 2008       Accepted 24 September 2008

Copyright © 2009 Korean Ophthalmological Society

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Purpose

To compare the clinical efficacy, duration of effect, and safety of Dysport and Botox for patients with essential blepharospasm using functional disability scale.

Methods

Patients with a confirmed diagnosis of essential blepharospasm who had received Botox (Allergan, USA) from September 2006 to May 2007 were enrolled in this study. We switched from Botox to Dysport (Ipsen, UK) after the botulinum effect of previous injection had disappeared and compared the clinical efficacy of two drugs. We used a 2.5:1 Dysport:Botox conversion ratio. The clinical efficacy of the drugs treatment was evaluated using a functional disability scale. We compared the duration of the effect and the safety of the two drugs.

Results

The study included 48 patients (43 women, 5 men). There was no significant difference in mean functional disability scores or in any item of the functional disability scale. There was no significant difference in duration of effect between Botox (100.2±37.34 days) and Dysport (99.1±39.7days). There was also no significant difference in frequency of adverse reaction between Botox (13%) and Dysport (10%).

Conclusions

When a dose conversion of 2.5:1 Dysport:Botox was used for essential blepharospasm patients, the two drugs displayed almost identical clinical efficacy, duration of effect, and safety.

Keywords: Botulinum neurotoxin A, Conversion ratio, Essential blepharospasm

References

1. Durif F. Clinical bioequivalence of the current commercial preparations of botulinum toxins. Eur J Neurol. 1995; 2:17–8.
2. Nüssgens Z, Roggenkämper P. Comparison of two botulinumtoxin preparations in the treatment of essential blepharospasm. Graefes Arch Clin Exp Ophthalmol. 1997; 235:197–9.
3. Sampaio C, Ferreira J, Simões F, et al. DYSBOT: a single- blind, randomized parallel study to determine whether any differences can be detected in the efficacy and tolerability of two formulations of botulinum toxin type A–Dysport and Botox–assuming a ratio of 4:1. Mov Disord. 1997; 12:1013–8.
4. Marchetti A, Magar R, Findley L, et al. Retrospective evaluation of the Dose of Dysport and Botox in the management of cervical dystonia and blepharospasm: The REAL DOSE study. Mov Disord. 2005; 20:937–44.
crossref
5. Dressler D. Pharmacological aspects of therapeutic botulinum toxin preparations. Nervenarzt. 2006; 77:912–21.
6. Karsai S, Adrian R, Hammers S, et al. A randomized double- blind study of the effect of Botox and Dusport/Reloxin on forehead wrinkles and electromyographic activity. Arch Dermatol. 2007; 143:1447–9.
crossref
7. Dewandre L, Voloshchenko A, Trembach IV. Pilot study to compare the efficacy and the duration of activity of Dysport vs Botox in classical esthetic indications (forehead, glabella, crow's feet). J Med Esth et Chir Dermatol. 2003; 118:101–7.
8. Lowe P, Patnaik R, Lowe N. Comparison of two formulations of botulinum toxin type A for the treatment of glabellar lines: a double-blinded, randomized study. J Am Acad Dermatol. 2006; 55:975–80.
9. Wohlfarth K, Göschel H, Frevert J, et al. Botulinum A toxins: units versus units. Naunyn Schmiedebergs Arch Pharmacol. 1997; 355:335–40.
crossref
10. Sampaio C, Costa J, Ferreira JJ. Clinical comparability of marketed formulations of botulinum toxin. Mov Disord. 2004; 19:129–36.
crossref
11. Grivet D, Robert PY, Thuret G, et al. Assessment of blepharospasm surgery using an improved disability scale: study of 138 patients. Ophthal Plast Reconstr Surg. 2005; 21:230–4.
crossref
12. Foster KA, Bigalke H, Aoki KR. Botulinum neurotoxin from laboratory to bedside. Neurotox Res. 2006; 9:133–40.
13. Rosales RL, Bigalke H, Dressler D. Pharmacology of botulinum toxin: differences between type A preparations. Eur J Neurol. 2006; 13:2–10.
crossref
14. De Almeida AT, De Boulle K. Diffusion characteristics of botulinum neurotoxin products and their clinical significance in cosmetic applications. J Cosmet Laser Ther. 2007; 9:17–22.

Table 1.
Comparison of published studies
Study Method Equivalence
Ruban et al, 1993 Animal study 6:1
Nüssgens et al, 1996 Randomized, double blinded study 4:1
Sampaio et al, 1997 Randomized, multi-center, single blind study 4:1
Marchetti et al, 2005 Multi-center, cross-over study 3:1
Dressler et al, 2006 Animal study 3:1
Karsai et al, 2007 Randomized, double blinded study Less than 3:1
Dewandre et al, 2003 Half face study (clinical observation) 2.5:1
Lowe et al, 2006 Randomized, double blinded study 2.5:1
Wohlfarth et al, 1997 Animal study 1:1
Table 2.
Functional disability score11
Type of activity Disability Score
Reading No disability 0
  Mild disability, but no limitation over time 1
  High disability, limited to newspaper page 2
  Very high disability, limited to newspaper headlines 3
  Activity impossible 4
Watching television No disability 0
  Mild disability, limited to one film (about 2 hours) 1
  High disability, limited to news and one sitcom (30 minutes environ) 2
  Very high disability, “Listen more than watch” 3
  Activity disability 4
Household activities (cleaning, etc.) No disability 0
  Mild disability, Household activities with no time limit 1
  High disability, Household activities with time limit 2
  Very high disability, household activities reduced to the minimum 3
  Activities impossible 4
Mobility No disability 0
  Mild disability, no space limit 1
  High disability, difficult to cross the road 2
  Very high disability, difficult to leave usual residence 3
  Activities impossible 4
Driving No disability 0
  Moderate disability, but driving not restricted 1
  High disability, driving restricted short inter-urban journeys 2
  Very high disability, driving restricted to the minimum 3
  Activities impossible 4
Work No disability 0
  Moderate disability, professional activities with no time limit 1
  High disability, professional activities with time limit 2
  Very high disability, activities reduced to the minimum 3
  Activities impossible 4
Table 3.
Comparison of clinical efficacy
  Botox Dysport p value
Mean FDS* 10.85±4.66 10.96±4.68 0.95†
Reading 1.90±0.90 1.91±0.92 0.91†
Watching television 1.67±0.86 1.71±0.85 0.81†
Household activities 1.65±0.81 1.67±0.81 0.90†
Mobility 1.60±0.79 1.58±0.79 0.90†
Driving 2.15±1.13 2.15±1.15 1.0†
Work 1.90±0.83 1.94±0.86 0.81†

*FDS=functional disability score

†p value analysed by independent-samples T test.

Table 4.
Numbers of patients with clinical adverse effects
  Botox Dysport
Ptosis 1 3
Severe ecchymosis at the injection site 3 1
Lid edema 1 1
Blurred vision 1 0
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