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Time course of efficacy of atogepant for the preventive treatment of migraine: Results from the randomized, double-blind ADVANCE trial
BACKGROUND: Atogepant is an oral, small-molecule, calcitonin gene–related peptide receptor antagonist for the preventive treatment of migraine. METHODS: In the double-blind, phase 3 ADVANCE trial, participants with 4–14 migraine days/month were randomized to atogepant 10 mg, 30 mg, 60 mg, or placebo...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
SAGE Publications
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8739573/ https://www.ncbi.nlm.nih.gov/pubmed/34521260 http://dx.doi.org/10.1177/03331024211042385 |
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author | Schwedt, Todd J Lipton, Richard B Ailani, Jessica Silberstein, Stephen D Tassorelli, Cristina Guo, Hua Lu, Kaifeng Dabruzzo, Brett Miceli, Rosa Severt, Lawrence Finnegan, Michelle Trugman, Joel M |
author_facet | Schwedt, Todd J Lipton, Richard B Ailani, Jessica Silberstein, Stephen D Tassorelli, Cristina Guo, Hua Lu, Kaifeng Dabruzzo, Brett Miceli, Rosa Severt, Lawrence Finnegan, Michelle Trugman, Joel M |
author_sort | Schwedt, Todd J |
collection | PubMed |
description | BACKGROUND: Atogepant is an oral, small-molecule, calcitonin gene–related peptide receptor antagonist for the preventive treatment of migraine. METHODS: In the double-blind, phase 3 ADVANCE trial, participants with 4–14 migraine days/month were randomized to atogepant 10 mg, 30 mg, 60 mg, or placebo once daily for 12 weeks. We evaluated the time course of efficacy of atogepant for the preventive treatment of migraine. Analyses included change from baseline in mean monthly migraine days during each of the three 4-week treatment periods, change in weekly migraine days during weeks 1–4, and proportion of participants with a migraine on each day during the first week. RESULTS: We analyzed 873 participants (n = 214 atogepant 10 mg, n = 223 atogepant 30 mg, n = 222 atogepant 60 mg, n = 214 placebo). For weeks 1–4, mean change from baseline in mean monthly migraine days ranged from −3.1 to −3.9 across atogepant doses vs −1.6 for placebo (p < 0.0001). For weeks 5–8 and 9–12, reductions in mean monthly migraine days ranged from −3.7 to −4.2 for atogepant vs −2.9 for placebo (p ≤ 0.012) and −4.2 to −4.4 for atogepant vs −3.0 for placebo (p < 0.0002), respectively. Mean change from baseline in weekly migraine days in week 1 ranged from −0.77 to −1.03 for atogepant vs −0.29 with placebo (p < 0.0001). Percentages of participants reporting a migraine on post-dose day 1 ranged from 10.8% to 14.1% for atogepant vs 25.2% with placebo (p ≤ 0.0071). CONCLUSION: Atogepant demonstrated treatment benefits as early as the first full day after treatment initiation, and sustained efficacy across each 4-week interval during the 12-week treatment period. Clinical trial registration: ClinicalTrials.gov identifier: NCT03777059 |
format | Online Article Text |
id | pubmed-8739573 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | SAGE Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-87395732022-01-08 Time course of efficacy of atogepant for the preventive treatment of migraine: Results from the randomized, double-blind ADVANCE trial Schwedt, Todd J Lipton, Richard B Ailani, Jessica Silberstein, Stephen D Tassorelli, Cristina Guo, Hua Lu, Kaifeng Dabruzzo, Brett Miceli, Rosa Severt, Lawrence Finnegan, Michelle Trugman, Joel M Cephalalgia Original Articles BACKGROUND: Atogepant is an oral, small-molecule, calcitonin gene–related peptide receptor antagonist for the preventive treatment of migraine. METHODS: In the double-blind, phase 3 ADVANCE trial, participants with 4–14 migraine days/month were randomized to atogepant 10 mg, 30 mg, 60 mg, or placebo once daily for 12 weeks. We evaluated the time course of efficacy of atogepant for the preventive treatment of migraine. Analyses included change from baseline in mean monthly migraine days during each of the three 4-week treatment periods, change in weekly migraine days during weeks 1–4, and proportion of participants with a migraine on each day during the first week. RESULTS: We analyzed 873 participants (n = 214 atogepant 10 mg, n = 223 atogepant 30 mg, n = 222 atogepant 60 mg, n = 214 placebo). For weeks 1–4, mean change from baseline in mean monthly migraine days ranged from −3.1 to −3.9 across atogepant doses vs −1.6 for placebo (p < 0.0001). For weeks 5–8 and 9–12, reductions in mean monthly migraine days ranged from −3.7 to −4.2 for atogepant vs −2.9 for placebo (p ≤ 0.012) and −4.2 to −4.4 for atogepant vs −3.0 for placebo (p < 0.0002), respectively. Mean change from baseline in weekly migraine days in week 1 ranged from −0.77 to −1.03 for atogepant vs −0.29 with placebo (p < 0.0001). Percentages of participants reporting a migraine on post-dose day 1 ranged from 10.8% to 14.1% for atogepant vs 25.2% with placebo (p ≤ 0.0071). CONCLUSION: Atogepant demonstrated treatment benefits as early as the first full day after treatment initiation, and sustained efficacy across each 4-week interval during the 12-week treatment period. Clinical trial registration: ClinicalTrials.gov identifier: NCT03777059 SAGE Publications 2021-09-14 2022-01 /pmc/articles/PMC8739573/ /pubmed/34521260 http://dx.doi.org/10.1177/03331024211042385 Text en © International Headache Society 2021 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage). |
spellingShingle | Original Articles Schwedt, Todd J Lipton, Richard B Ailani, Jessica Silberstein, Stephen D Tassorelli, Cristina Guo, Hua Lu, Kaifeng Dabruzzo, Brett Miceli, Rosa Severt, Lawrence Finnegan, Michelle Trugman, Joel M Time course of efficacy of atogepant for the preventive treatment of migraine: Results from the randomized, double-blind ADVANCE trial |
title | Time course of efficacy of atogepant for the preventive treatment of migraine: Results from the randomized, double-blind ADVANCE trial |
title_full | Time course of efficacy of atogepant for the preventive treatment of migraine: Results from the randomized, double-blind ADVANCE trial |
title_fullStr | Time course of efficacy of atogepant for the preventive treatment of migraine: Results from the randomized, double-blind ADVANCE trial |
title_full_unstemmed | Time course of efficacy of atogepant for the preventive treatment of migraine: Results from the randomized, double-blind ADVANCE trial |
title_short | Time course of efficacy of atogepant for the preventive treatment of migraine: Results from the randomized, double-blind ADVANCE trial |
title_sort | time course of efficacy of atogepant for the preventive treatment of migraine: results from the randomized, double-blind advance trial |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8739573/ https://www.ncbi.nlm.nih.gov/pubmed/34521260 http://dx.doi.org/10.1177/03331024211042385 |
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