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Long-term safety of abobotulinumtoxinA for the treatment of glabellar lines: results from a 36-month, multicenter, open-label extension study.
- Source :
-
Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.] [Dermatol Surg] 2014 Feb; Vol. 40 (2), pp. 176-83. Date of Electronic Publication: 2013 Dec 26. - Publication Year :
- 2014
-
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.<br />Objective: To report the long-term safety and efficacy of abobotulinumtoxinA in patients with moderate to severe glabellar lines.<br />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.<br />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.<br />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.<br /> (© 2013 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.)
Details
- Language :
- English
- ISSN :
- 1524-4725
- Volume :
- 40
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.]
- Publication Type :
- Academic Journal
- Accession number :
- 24372978
- Full Text :
- https://doi.org/10.1111/dsu.12404