Safety and tolerability of atogepant for the preventive treatment of migraine: a post hoc analysis of pooled data from four clinical trials

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Standard

Safety and tolerability of atogepant for the preventive treatment of migraine : a post hoc analysis of pooled data from four clinical trials. / Rizzoli, Paul; Marmura, Michael J.; Robblee, Jennifer; McVige, Jennifer; Sacco, Sara; Nahas, Stephanie J.; Ailani, Jessica; De Abreu Ferreira, Rosa; Ma, Julia; Smith, Jonathan H.; Dabruzzo, Brett; Ashina, Messoud.

In: Journal of Headache and Pain, Vol. 25, No. 1, 35, 2024.

Research output: Contribution to journalJournal articleResearchpeer-review

Harvard

Rizzoli, P, Marmura, MJ, Robblee, J, McVige, J, Sacco, S, Nahas, SJ, Ailani, J, De Abreu Ferreira, R, Ma, J, Smith, JH, Dabruzzo, B & Ashina, M 2024, 'Safety and tolerability of atogepant for the preventive treatment of migraine: a post hoc analysis of pooled data from four clinical trials', Journal of Headache and Pain, vol. 25, no. 1, 35. https://doi.org/10.1186/s10194-024-01736-z

APA

Rizzoli, P., Marmura, M. J., Robblee, J., McVige, J., Sacco, S., Nahas, S. J., Ailani, J., De Abreu Ferreira, R., Ma, J., Smith, J. H., Dabruzzo, B., & Ashina, M. (2024). Safety and tolerability of atogepant for the preventive treatment of migraine: a post hoc analysis of pooled data from four clinical trials. Journal of Headache and Pain, 25(1), [35]. https://doi.org/10.1186/s10194-024-01736-z

Vancouver

Rizzoli P, Marmura MJ, Robblee J, McVige J, Sacco S, Nahas SJ et al. Safety and tolerability of atogepant for the preventive treatment of migraine: a post hoc analysis of pooled data from four clinical trials. Journal of Headache and Pain. 2024;25(1). 35. https://doi.org/10.1186/s10194-024-01736-z

Author

Rizzoli, Paul ; Marmura, Michael J. ; Robblee, Jennifer ; McVige, Jennifer ; Sacco, Sara ; Nahas, Stephanie J. ; Ailani, Jessica ; De Abreu Ferreira, Rosa ; Ma, Julia ; Smith, Jonathan H. ; Dabruzzo, Brett ; Ashina, Messoud. / Safety and tolerability of atogepant for the preventive treatment of migraine : a post hoc analysis of pooled data from four clinical trials. In: Journal of Headache and Pain. 2024 ; Vol. 25, No. 1.

Bibtex

@article{27906e85d64d4cb288f82f58f983d0f5,
title = "Safety and tolerability of atogepant for the preventive treatment of migraine: a post hoc analysis of pooled data from four clinical trials",
abstract = "Background: Conventional, non-specific preventive migraine treatments often demonstrate low rates of treatment persistence due to poor efficacy or tolerability. Effective, well-tolerated preventive treatments are needed to reduce migraine symptoms, improve function, and enhance quality of life. Atogepant is a migraine-specific oral calcitonin gene–related peptide receptor antagonist that is indicated for the preventive treatment of migraine in adults. This analysis evaluated the safety and tolerability profile of atogepant for the preventive treatment of migraine, including adverse events (AEs) of interest, such as constipation, nausea, hepatic safety, weight changes, and cardiac disorders. Methods: This post hoc analysis was performed using data pooled from 2 (12-week) randomized, double-blind, placebo-controlled trials (RCTs) and 2 (40- and 52-week) open-label long-term safety (LTS) trials of oral atogepant for episodic migraine (EM). Results: The safety population included 1550 participants from the pooled RCTs (atogepant, n = 1142; placebo, n = 408) and 1424 participants from the pooled LTS trials (atogepant, n = 1228; standard care [SC], n = 196). In total, 643/1142 (56.3%) atogepant participants and 218/408 (53.4%) placebo participants experienced ≥ 1 treatment-emergent AEs (TEAEs) in the RCTs. In the LTS trials, 792/1228 (64.5%) of atogepant participants and 154/196 (78.6%) of SC participants experienced ≥ 1 TEAEs. The most commonly reported TEAEs (≥ 5%) in participants who received atogepant once daily were upper respiratory tract infection (5.3% in RCTs, 7.7% in LTS trials), constipation (6.1% in RCTs, 5.0% in LTS trials), nausea (6.6% in RCTs, 4.6% in LTS trials), and urinary tract infection (3.4% in RCTs, 5.2% in LTS trials). Additionally, weight loss appeared to be dose- and duration-dependent. Most TEAEs were considered unrelated to study drug and few led to discontinuation. Conclusions: Overall, atogepant is safe and well tolerated in pooled RCTs and LTS trials for the preventive treatment of EM in adults. Trial registration: ClinicalTrials.gov identifiers: NCT02848326 (MD-01), NCT03777059 (ADVANCE), NCT03700320 (study 302), NCT03939312 (study 309). Graphical Abstract: (Figure presented.)",
keywords = "Calcitonin gene–related peptide, Migraine, Safety, Tolerability",
author = "Paul Rizzoli and Marmura, {Michael J.} and Jennifer Robblee and Jennifer McVige and Sara Sacco and Nahas, {Stephanie J.} and Jessica Ailani and {De Abreu Ferreira}, Rosa and Julia Ma and Smith, {Jonathan H.} and Brett Dabruzzo and Messoud Ashina",
note = "Publisher Copyright: {\textcopyright} The Author(s) 2024.",
year = "2024",
doi = "10.1186/s10194-024-01736-z",
language = "English",
volume = "25",
journal = "Journal of Headache and Pain",
issn = "1129-2369",
publisher = "SpringerOpen",
number = "1",

}

RIS

TY - JOUR

T1 - Safety and tolerability of atogepant for the preventive treatment of migraine

T2 - a post hoc analysis of pooled data from four clinical trials

AU - Rizzoli, Paul

AU - Marmura, Michael J.

AU - Robblee, Jennifer

AU - McVige, Jennifer

AU - Sacco, Sara

AU - Nahas, Stephanie J.

AU - Ailani, Jessica

AU - De Abreu Ferreira, Rosa

AU - Ma, Julia

AU - Smith, Jonathan H.

AU - Dabruzzo, Brett

AU - Ashina, Messoud

N1 - Publisher Copyright: © The Author(s) 2024.

PY - 2024

Y1 - 2024

N2 - Background: Conventional, non-specific preventive migraine treatments often demonstrate low rates of treatment persistence due to poor efficacy or tolerability. Effective, well-tolerated preventive treatments are needed to reduce migraine symptoms, improve function, and enhance quality of life. Atogepant is a migraine-specific oral calcitonin gene–related peptide receptor antagonist that is indicated for the preventive treatment of migraine in adults. This analysis evaluated the safety and tolerability profile of atogepant for the preventive treatment of migraine, including adverse events (AEs) of interest, such as constipation, nausea, hepatic safety, weight changes, and cardiac disorders. Methods: This post hoc analysis was performed using data pooled from 2 (12-week) randomized, double-blind, placebo-controlled trials (RCTs) and 2 (40- and 52-week) open-label long-term safety (LTS) trials of oral atogepant for episodic migraine (EM). Results: The safety population included 1550 participants from the pooled RCTs (atogepant, n = 1142; placebo, n = 408) and 1424 participants from the pooled LTS trials (atogepant, n = 1228; standard care [SC], n = 196). In total, 643/1142 (56.3%) atogepant participants and 218/408 (53.4%) placebo participants experienced ≥ 1 treatment-emergent AEs (TEAEs) in the RCTs. In the LTS trials, 792/1228 (64.5%) of atogepant participants and 154/196 (78.6%) of SC participants experienced ≥ 1 TEAEs. The most commonly reported TEAEs (≥ 5%) in participants who received atogepant once daily were upper respiratory tract infection (5.3% in RCTs, 7.7% in LTS trials), constipation (6.1% in RCTs, 5.0% in LTS trials), nausea (6.6% in RCTs, 4.6% in LTS trials), and urinary tract infection (3.4% in RCTs, 5.2% in LTS trials). Additionally, weight loss appeared to be dose- and duration-dependent. Most TEAEs were considered unrelated to study drug and few led to discontinuation. Conclusions: Overall, atogepant is safe and well tolerated in pooled RCTs and LTS trials for the preventive treatment of EM in adults. Trial registration: ClinicalTrials.gov identifiers: NCT02848326 (MD-01), NCT03777059 (ADVANCE), NCT03700320 (study 302), NCT03939312 (study 309). Graphical Abstract: (Figure presented.)

AB - Background: Conventional, non-specific preventive migraine treatments often demonstrate low rates of treatment persistence due to poor efficacy or tolerability. Effective, well-tolerated preventive treatments are needed to reduce migraine symptoms, improve function, and enhance quality of life. Atogepant is a migraine-specific oral calcitonin gene–related peptide receptor antagonist that is indicated for the preventive treatment of migraine in adults. This analysis evaluated the safety and tolerability profile of atogepant for the preventive treatment of migraine, including adverse events (AEs) of interest, such as constipation, nausea, hepatic safety, weight changes, and cardiac disorders. Methods: This post hoc analysis was performed using data pooled from 2 (12-week) randomized, double-blind, placebo-controlled trials (RCTs) and 2 (40- and 52-week) open-label long-term safety (LTS) trials of oral atogepant for episodic migraine (EM). Results: The safety population included 1550 participants from the pooled RCTs (atogepant, n = 1142; placebo, n = 408) and 1424 participants from the pooled LTS trials (atogepant, n = 1228; standard care [SC], n = 196). In total, 643/1142 (56.3%) atogepant participants and 218/408 (53.4%) placebo participants experienced ≥ 1 treatment-emergent AEs (TEAEs) in the RCTs. In the LTS trials, 792/1228 (64.5%) of atogepant participants and 154/196 (78.6%) of SC participants experienced ≥ 1 TEAEs. The most commonly reported TEAEs (≥ 5%) in participants who received atogepant once daily were upper respiratory tract infection (5.3% in RCTs, 7.7% in LTS trials), constipation (6.1% in RCTs, 5.0% in LTS trials), nausea (6.6% in RCTs, 4.6% in LTS trials), and urinary tract infection (3.4% in RCTs, 5.2% in LTS trials). Additionally, weight loss appeared to be dose- and duration-dependent. Most TEAEs were considered unrelated to study drug and few led to discontinuation. Conclusions: Overall, atogepant is safe and well tolerated in pooled RCTs and LTS trials for the preventive treatment of EM in adults. Trial registration: ClinicalTrials.gov identifiers: NCT02848326 (MD-01), NCT03777059 (ADVANCE), NCT03700320 (study 302), NCT03939312 (study 309). Graphical Abstract: (Figure presented.)

KW - Calcitonin gene–related peptide

KW - Migraine

KW - Safety

KW - Tolerability

U2 - 10.1186/s10194-024-01736-z

DO - 10.1186/s10194-024-01736-z

M3 - Journal article

C2 - 38462625

AN - SCOPUS:85187146170

VL - 25

JO - Journal of Headache and Pain

JF - Journal of Headache and Pain

SN - 1129-2369

IS - 1

M1 - 35

ER -

ID: 385685144