PrabotulinumtoxinA-xvfs for the Treatment of Moderate-to-Severe Glabellar Lines
OBJECTIVE: PrabotulinumtoxinA-xvfs (Jeuveau), a botulinum toxin type A, was approved by the Food and Drug Administration for the temporary improvement in the appearance of moderate-to-severe glabellar lines in February 2019. This article will review phase II and III clinical trials to assess the efficacy, safety, and clinical application of this novel, aesthetic-only drug.
DATA SOURCES: A systematic literature review was performed using the terms "glabellar lines AND prabotulinumtoxinA" in the PubMed database. ClinicalTrials.gov was searched to identify nonpublished studies.
STUDY SELECTION AND DATA EXTRACTION: Articles written in English between November 2019 and June 2020 discussing phase II and phase III clinical trials were evaluated.
DATA SYNTHESIS: By the primary efficacy end point on day 30, more patients achieved a greater than 2-point improvement on the Glabellar Line Scale (GLS) at maximum frown compared with baseline on day 0. The proportions of participants who responded to treatment with prabotulinumtoxinA were 67.5% and 70.4% versus 1.2% and 1.3% in placebo groups across 2 identical clinical trials (P < 0.001). Patients receiving prabotulinumtoxinA experienced greater improvement in GLS at maximum frown on day 30 (87.2%) compared with onabotulinumtoxinA (82.8%) and placebo (4.2%; P < 0.001). PrabotulinumtoxinA was well tolerated across all studies.
RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: This review provides a detailed analysis of the safety and efficacy of prabotulinumtoxinA-xvfs and includes special considerations to help guide patients and clinicians.
CONCLUSION: PrabotulinumtoxinA is a safe and effective new addition to the repository of available treatments for the appearance of glabellar lines.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:55 |
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| Enthalten in: |
The Annals of pharmacotherapy - 55(2021), 3 vom: 27. März, Seite 354-361 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Gadarowski, Mary B [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 19.04.2021 Date Revised 19.04.2021 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1177/1060028020943527 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM312747152 |
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| 100 | 1 | |a Gadarowski, Mary B |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a PrabotulinumtoxinA-xvfs for the Treatment of Moderate-to-Severe Glabellar Lines |
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| 500 | |a Citation Status MEDLINE | ||
| 520 | |a OBJECTIVE: PrabotulinumtoxinA-xvfs (Jeuveau), a botulinum toxin type A, was approved by the Food and Drug Administration for the temporary improvement in the appearance of moderate-to-severe glabellar lines in February 2019. This article will review phase II and III clinical trials to assess the efficacy, safety, and clinical application of this novel, aesthetic-only drug | ||
| 520 | |a DATA SOURCES: A systematic literature review was performed using the terms "glabellar lines AND prabotulinumtoxinA" in the PubMed database. ClinicalTrials.gov was searched to identify nonpublished studies | ||
| 520 | |a STUDY SELECTION AND DATA EXTRACTION: Articles written in English between November 2019 and June 2020 discussing phase II and phase III clinical trials were evaluated | ||
| 520 | |a DATA SYNTHESIS: By the primary efficacy end point on day 30, more patients achieved a greater than 2-point improvement on the Glabellar Line Scale (GLS) at maximum frown compared with baseline on day 0. The proportions of participants who responded to treatment with prabotulinumtoxinA were 67.5% and 70.4% versus 1.2% and 1.3% in placebo groups across 2 identical clinical trials (P < 0.001). Patients receiving prabotulinumtoxinA experienced greater improvement in GLS at maximum frown on day 30 (87.2%) compared with onabotulinumtoxinA (82.8%) and placebo (4.2%; P < 0.001). PrabotulinumtoxinA was well tolerated across all studies | ||
| 520 | |a RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: This review provides a detailed analysis of the safety and efficacy of prabotulinumtoxinA-xvfs and includes special considerations to help guide patients and clinicians | ||
| 520 | |a CONCLUSION: PrabotulinumtoxinA is a safe and effective new addition to the repository of available treatments for the appearance of glabellar lines | ||
| 650 | 4 | |a Journal Article | |
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