Long-term safety of abobotulinumtoxinA for the treatment of glabellar lines: results from a 36-month, multicenter, open-label extension study.
Dermatol Surg
; 40(2): 176-83, 2014 Feb.
Article
em En
| MEDLINE
| ID: mdl-24372978
ABSTRACT
BACKGROUND:
Because abobotulinumtoxinA treatment for glabellar lines must be repeated regularly to prevent recurrence, understanding the safety and effectiveness of long-term, repeated administration of abobotulinumtoxinA is important.OBJECTIVE:
To report the long-term safety and efficacy of abobotulinumtoxinA in patients with moderate to severe glabellar lines. METHODS AND MATERIALS AbobotulinumtoxinA was administered to 1,415 patients in multiple cycles over 24 months as a fixed dose of 50 U or as a dose based on muscle mass and sex (women 50-70 U; men 60-80 U). Adverse events were assessed after each visit on days 7, 14, and 30 and monthly thereafter; monitoring continued every 3 months for a total safety monitoring duration of 36 months or less.RESULTS:
Nine hundred ninety-one (70%) patients reported treatment-emergent adverse effects (TEAEs); most events were mild (70%) or moderate (20%) in severity. The rate of TEAEs did not increase over 24 months of repeated treatment (mean 5.6 cycles; range 1-9). Treatment-related eyelid ptosis followed 53 of 7,938 (0.7%) treatments, all of which resolved spontaneously.CONCLUSIONS:
Multiple cycles of abobotulinumtoxinA treatment over 24 months were well tolerated and effective for the correction of glabellar lines, with no evidence of cumulative safety problems.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Envelhecimento da Pele
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Toxinas Botulínicas Tipo A
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Fármacos Neuromusculares
Tipo de estudo:
Clinical_trials
Limite:
Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2014
Tipo de documento:
Article