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Efficacy and Safety of ATX-101 by Treatment Session: Pooled Analysis of Data From the Phase 3 REFINE Trials
BACKGROUND: ATX-101 (deoxycholic acid injection) is the only injectable drug approved for submental fat (SMF) reduction. In the phase 3 REFINE trials, adults with moderate or severe SMF who were dissatisfied with the appearance of their face/chin were eligible to receive up to 6 treatment sessions w...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6094350/ https://www.ncbi.nlm.nih.gov/pubmed/29401213 http://dx.doi.org/10.1093/asj/sjy008 |
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author | Dayan, Steven H Schlessinger, Joel Beer, Kenneth Donofrio, Lisa M Jones, Derek H Humphrey, Shannon Carruthers, Jean Lizzul, Paul F Gross, Todd M Beddingfield, Frederick C Somogyi, Christine |
author_facet | Dayan, Steven H Schlessinger, Joel Beer, Kenneth Donofrio, Lisa M Jones, Derek H Humphrey, Shannon Carruthers, Jean Lizzul, Paul F Gross, Todd M Beddingfield, Frederick C Somogyi, Christine |
author_sort | Dayan, Steven H |
collection | PubMed |
description | BACKGROUND: ATX-101 (deoxycholic acid injection) is the only injectable drug approved for submental fat (SMF) reduction. In the phase 3 REFINE trials, adults with moderate or severe SMF who were dissatisfied with the appearance of their face/chin were eligible to receive up to 6 treatment sessions with ATX-101 (2 mg/cm(2)) or placebo. Primary and secondary endpoints, evaluated at 12 weeks after last treatment, significantly favored ATX-101 supporting its efficacy for reducing SMF and the psychological impact of SMF, and increasing satisfaction with the appearance of the face/chin. OBJECTIVES: To evaluate the efficacy and safety of ATX-101 by treatment session. METHODS: This post hoc analysis used pooled data from the REFINE trials to evaluate efficacy endpoints and adverse events following each treatment session to further characterize the ATX-101 treatment response and safety profile. RESULTS: In both treatment groups, mean injection volume declined over subsequent treatment sessions, though more markedly in the ATX-101 group. The majority of ATX-101–treated patients achieved a ≥1-grade improvement in SMF within 2 to 4 treatment sessions based on either clinician or patient assessment. Furthermore, 19.1% of ATX-101–treated patients (vs 3.9% of placebo-treated patients) received fewer than 6 treatment sessions owing to patient satisfaction with treatment or lack of sufficient SMF for further treatment. In both treatment groups, the incidence/severity of common injection-site adverse events declined over subsequent treatment sessions. CONCLUSIONS: Although up to 6 treatment sessions were permitted in the REFINE trials, most ATX-101–treated patients achieved an improvement in SMF within 2 to 4 treatment sessions. Level of Evidence: 3 [Image: see text] |
format | Online Article Text |
id | pubmed-6094350 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-60943502018-08-22 Efficacy and Safety of ATX-101 by Treatment Session: Pooled Analysis of Data From the Phase 3 REFINE Trials Dayan, Steven H Schlessinger, Joel Beer, Kenneth Donofrio, Lisa M Jones, Derek H Humphrey, Shannon Carruthers, Jean Lizzul, Paul F Gross, Todd M Beddingfield, Frederick C Somogyi, Christine Aesthet Surg J Cosmetic Medicine BACKGROUND: ATX-101 (deoxycholic acid injection) is the only injectable drug approved for submental fat (SMF) reduction. In the phase 3 REFINE trials, adults with moderate or severe SMF who were dissatisfied with the appearance of their face/chin were eligible to receive up to 6 treatment sessions with ATX-101 (2 mg/cm(2)) or placebo. Primary and secondary endpoints, evaluated at 12 weeks after last treatment, significantly favored ATX-101 supporting its efficacy for reducing SMF and the psychological impact of SMF, and increasing satisfaction with the appearance of the face/chin. OBJECTIVES: To evaluate the efficacy and safety of ATX-101 by treatment session. METHODS: This post hoc analysis used pooled data from the REFINE trials to evaluate efficacy endpoints and adverse events following each treatment session to further characterize the ATX-101 treatment response and safety profile. RESULTS: In both treatment groups, mean injection volume declined over subsequent treatment sessions, though more markedly in the ATX-101 group. The majority of ATX-101–treated patients achieved a ≥1-grade improvement in SMF within 2 to 4 treatment sessions based on either clinician or patient assessment. Furthermore, 19.1% of ATX-101–treated patients (vs 3.9% of placebo-treated patients) received fewer than 6 treatment sessions owing to patient satisfaction with treatment or lack of sufficient SMF for further treatment. In both treatment groups, the incidence/severity of common injection-site adverse events declined over subsequent treatment sessions. CONCLUSIONS: Although up to 6 treatment sessions were permitted in the REFINE trials, most ATX-101–treated patients achieved an improvement in SMF within 2 to 4 treatment sessions. Level of Evidence: 3 [Image: see text] Oxford University Press 2018-08 2018-02-01 /pmc/articles/PMC6094350/ /pubmed/29401213 http://dx.doi.org/10.1093/asj/sjy008 Text en © 2018 The American Society for Aesthetic Plastic Surgery, Inc. http://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com |
spellingShingle | Cosmetic Medicine Dayan, Steven H Schlessinger, Joel Beer, Kenneth Donofrio, Lisa M Jones, Derek H Humphrey, Shannon Carruthers, Jean Lizzul, Paul F Gross, Todd M Beddingfield, Frederick C Somogyi, Christine Efficacy and Safety of ATX-101 by Treatment Session: Pooled Analysis of Data From the Phase 3 REFINE Trials |
title | Efficacy and Safety of ATX-101 by Treatment Session: Pooled Analysis of Data From the Phase 3 REFINE Trials |
title_full | Efficacy and Safety of ATX-101 by Treatment Session: Pooled Analysis of Data From the Phase 3 REFINE Trials |
title_fullStr | Efficacy and Safety of ATX-101 by Treatment Session: Pooled Analysis of Data From the Phase 3 REFINE Trials |
title_full_unstemmed | Efficacy and Safety of ATX-101 by Treatment Session: Pooled Analysis of Data From the Phase 3 REFINE Trials |
title_short | Efficacy and Safety of ATX-101 by Treatment Session: Pooled Analysis of Data From the Phase 3 REFINE Trials |
title_sort | efficacy and safety of atx-101 by treatment session: pooled analysis of data from the phase 3 refine trials |
topic | Cosmetic Medicine |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6094350/ https://www.ncbi.nlm.nih.gov/pubmed/29401213 http://dx.doi.org/10.1093/asj/sjy008 |
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