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Botulinum Toxin: Formulation, Concentration and Treatment
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Neuroscience, Neurology.
2012 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Botulinum toxin (BTX) is used in various fields of medicine, including the treatment of hyperhidrosis and cervical dystonia. Botox®, Dysport®, Xeomin® and NeuroBloc® are commercially available BTX products, which are formulated differently and their dosing units are unique. Dosage and concentration of the prepared solution for injection varies considerably among studies comparing the products. Improved guidelines on concentration and dosing when changing from one product to another are warranted. This would ensure the use of the lowest effective doses for good effect, minimal risk of antibody formation and side-effects as well as reduced costs.

The aim of the present work was to find the most appropriate BTX concentration for each of the four products to achieve the highest sweat reducing effect and to investigate dose conversion ratios between Botox and Dysport in the treatment of cervical dystonia when the products are diluted to the same concentration, 100 U/ml.

Paper I and II clearly confirm that it is crucial to consider the BTX concentration in a treatment regimen, especially when changing between different products. The optimal concentration to reduce sweating varies among the products and was found to be 25 U/ml for Botox and Xeomin, approximately 100 U/ml for Dysport and 50 U/ml for NeuroBloc. However, for NeuroBloc the optimal concentration might be even lower.

In Paper III, which is a retrospective study using casebook notes from 75 patients with cervical dystonia, it was found that the most appropriate dose conversion ratio to use when switching from Botox to Dysport was 1:1.7.

In Paper IV, Botox and Dysport were prospectively compared in a double-blind, randomized clinical trial in two different dose conversion ratios (1:3 and 1:1.7) when diluted to the same concentration (100 U/ml). No statistically significant difference was seen between Botox (1:3) and Dysport nor between Botox (1:1.7) and Dysport four weeks after treatment. Some of the secondary outcome observations, however, did indicate that the ratio 1:3 resulted in suboptimal efficacy of Botox but this must be further validated in a larger patient material.

Place, publisher, year, edition, pages
Uppsala: Acta Universitatis Upsaliensis, 2012. , 67 p.
Series
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 1651-6206 ; 816
Keyword [en]
Botulinum toxin, Botox, Dysport, Xeomin, NeuroBloc, Hyperhidrosis, Cervical dystonia
National Category
Neurology Dermatology and Venereal Diseases
Research subject
Neurology
Identifiers
URN: urn:nbn:se:uu:diva-181667ISBN: 978-91-554-8481-1 (print)OAI: oai:DiVA.org:uu-181667DiVA: diva2:557397
Public defence
2012-11-09, Rudbecksalen, Dag Hammarskjöldsväg 20, Uppsala, 09:15 (Swedish)
Opponent
Supervisors
Available from: 2012-10-19 Created: 2012-09-27 Last updated: 2013-01-23Bibliographically approved
List of papers
1. Anhidrotic effect of intradermal injections of botulinum toxin: A comparison of different products and concentrations
Open this publication in new window or tab >>Anhidrotic effect of intradermal injections of botulinum toxin: A comparison of different products and concentrations
2008 (English)In: Acta Dermato-Venereologica, ISSN 0001-5555, E-ISSN 1651-2057, Vol. 88, no 3, 229-233 p.Article in journal (Refereed) Published
Abstract [en]

Botulinum toxin is used in various fields of medicine, including in the treatment of hyperhidrosis. Three products containing botulinum toxin are commercially available in Sweden; Botox, Dysport and Neurobloc. In the literature dose-response has varied with respect to these 3 products. We hypothesized that the dilution level of botulinum toxin is of importance for the effect and we therefore investigated anhidrosis after intradermal injections of each product in 3 different concentrations. Nine healthy subjects received 0.1 ml injections in the back. The anhidrotic areas were identified by an iodine-starch test after 3 weeks. When the 3 products were diluted to 100 U/ml level the achieved mean anhidrotic areas were approximately the same. This is in strong contrast with the large dose conversion factors suggested for intramuscular injections of the products. Furthermore, the lowest used concentrations for Botox(R) (25 U/ml) and Neurobloc (100 U/ml) led to the largest anhidrotic mean area per unit, respectively. The optimal concentration in this study was 25 U/ml for Botox, 100 U/ml for Dysport and 100 U/ml for Neurobloc, but for Botox and Neurobloc the optimal concentrations may be even lower.

National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:uu:diva-16179 (URN)10.2340/00015555-0419 (DOI)000256034500004 ()18480920 (PubMedID)
Available from: 2008-05-09 Created: 2008-05-09 Last updated: 2017-12-08Bibliographically approved
2. Effect of Botulinum Toxin Concentration on Reduction in Sweating: a randomized, double-blind study
Open this publication in new window or tab >>Effect of Botulinum Toxin Concentration on Reduction in Sweating: a randomized, double-blind study
Show others...
2013 (English)In: Acta Dermato-Venereologica, ISSN 0001-5555, E-ISSN 1651-2057, Vol. 93, no 6, 674-678 p.Article in journal (Refereed) Published
Abstract [en]

Dose-response studies of botulinum toxin for reduction of sweating are sparse in the literature. The aim of this study was to determine the most appropriate concentrations of Botox (R), Dysport (R), Xeomin (R) and NeuroBloc (R), respectively, in order to achieve the greatest reduction in sweating, thus reducing the costs and increasing the safety of treatment. Four concentrations of each product were investigated. Intradermal injections of all products and concentrations were applied to the backs of 20 consenting subjects, in a randomized, double-blind manner. Areas of anhidrotic and hypohidrotic skin were measured with an iodine-starch test after 4, 8 and 12 weeks, respectively. Optimal concentrations were found to be 25 U/ml for Botox and Xeomin, approximately 100 U/ml for Dysport, and 50 U/ml for NeuroBloc. When comparing the mean anhidrotic area per unit for 100 U/ml of each product, the calculated dose conversion ratios were 1:1.6:1.2:1.3 (Botox:Dysport:Xeomin:NeuroBloc). If, instead, the optimal concentration for each product was compared, the dose conversion ratios were 1:4.8:1.3:2.2. Thus, it is crucial to consider botulinum toxin concentration in a treatment regimen.

Keyword
Botox, Dysport, Xeomin, NeuroBloc, botulinum toxin, hyperhidrosis
National Category
Neurology Dermatology and Venereal Diseases
Identifiers
urn:nbn:se:uu:diva-181657 (URN)10.2340/00015555-1606 (DOI)000327231000006 ()23694974 (PubMedID)
Available from: 2012-09-27 Created: 2012-09-27 Last updated: 2017-12-07Bibliographically approved
3. Clinical Experience of Dose Conversion Ratios Between 2 Botulinum Toxin Products in the Treatment of Cervical Dystonia
Open this publication in new window or tab >>Clinical Experience of Dose Conversion Ratios Between 2 Botulinum Toxin Products in the Treatment of Cervical Dystonia
2012 (English)In: Clinical neuropharmacology, ISSN 0362-5664, E-ISSN 1537-162X, Vol. 35, no 6, 278-282 p.Article in journal (Refereed) Published
Abstract [en]

OBJECTIVES:

The units of different botulinum toxin products are not identical, and the dose equivalence has been debated for several years. In the year 2000, our clinic changed the recommended botulinum toxin product from Botox to Dysport for the treatment of cervical dystonia. Based on published reports, where dose conversion ratios from 1:1 to 1:6 (Botox:Dysport) had been used, and our own clinical experience, the dose conversion ratio was set to 1:2. The objective of this study was to retrospectively monitor the used doses of each product and the subsequent clinical effect.

METHODS:

A retrospective study, using casebook notes from 75 patients, was done to investigate treatment doses, subjective clinical effect, and the appearance of adverse events.

RESULTS:

The median dose conversion ratio that had been used at the product switch was 1:2.3 (Botox:Dysport). After clinical adjustment, the ratio was 1:2.1 at the next 3 treatments. There was a tendency for a more effective treatment and more adverse events after the product switch. A follow-up was performed 6.5 years later using casebook notes from 53 of the same patients. By this time, the doses had been reduced, and the median dose conversion ratio had decreased to 1:1.7 (Botox:Dysport). The adverse events reported at this point were fewer for the patients treated.

CONCLUSIONS:

In this study, the most appropriate dose conversion ratio to use when switching from Botox to Dysport was 1:1.7.

Keyword
botulinum toxin, Botox, Dysport, cervical dystonia, dose conversion ratio
National Category
Neurology
Identifiers
urn:nbn:se:uu:diva-181663 (URN)10.1097/WNF.0b013e3182711fc0 (DOI)000311982400005 ()
Available from: 2012-09-27 Created: 2012-09-27 Last updated: 2017-12-07Bibliographically approved
4. A comparison of Botox® 100 U/ml and Dysport® 100 U/ml using dose conversion ratio 1:3 and 1:1.7 in the treatment of cervical dystonia: a double-blind, randomized, cross-over trial.
Open this publication in new window or tab >>A comparison of Botox® 100 U/ml and Dysport® 100 U/ml using dose conversion ratio 1:3 and 1:1.7 in the treatment of cervical dystonia: a double-blind, randomized, cross-over trial.
Show others...
(English)Manuscript (preprint) (Other academic)
National Category
Neurology
Identifiers
urn:nbn:se:uu:diva-181665 (URN)
Available from: 2012-09-27 Created: 2012-09-27 Last updated: 2013-01-23

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