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. 2024 Dec;44(12):3331024241299753.
doi: 10.1177/03331024241299753.

Weight loss with atogepant during the preventive treatment of migraine: A pooled analysis

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Free article

Weight loss with atogepant during the preventive treatment of migraine: A pooled analysis

B Lee Peterlin et al. Cephalalgia. 2024 Dec.
Free article

Abstract

Background: Migraine is associated with obesity. These analyses evaluated weight change with atogepant used as a preventive migraine treatment.

Methods: Five atogepant clinical trials in adults with migraine (one phase 2b/3; four phase 3) were included: Three 12-week, randomized, placebo-controlled trials (episodic migraine: two; chronic migraine: one); one 40-week, open-label extension trial and one 52-week, standard care, randomized, long-term safety trial in episodic migraine. Change from baseline in body weight was measured.

Results: Mean baseline body mass indexes were 30.0-30.7 kg/m2 (pooled episodic migraine [United States only]) and 25.0-25.5 kg/m2 (chronic migraine [East Asia, Europe, and North America]). More participants treated with atogepant 60 mg once-daily compared to placebo experienced ≥7% weight loss at any time in the pooled episodic migraine placebo-controlled trials (4.9% vs. 2.8%), chronic migraine placebo-controlled trial (5.8% vs. 2.0%), and pooled open-label extension and long-term safety trials (24.0% vs.14.7% in standard care [long-term safety only]). In the placebo-controlled trials, weight loss with atogepant 60 mg once-daily was observed at week 2 (pooled episodic migraine: -0.32%; chronic migraine: -0.39%), increasing at week 12 (pooled episodic migraine: -1.02%; chronic migraine: -1.50%); compared to weight gain with placebo at week 12 (pooled episodic migraine: +0.49%; chronic migraine: +0.10%). In the long-term episodic migraine studies, weight loss with atogepant 60 mg once-daily was observed at week 4 (long-term safety: -0.42%; open-label extension: -0.76%), increasing at week 40 (long-term safety: -2.38%; open-label extension: -2.09%).

Conclusion: Atogepant was associated with modest dose- and duration-dependent weight loss.

Trial registration: ClinicalTrials.gov identifiers: NCT02848326 (CGP-MD-01); NCT03777059 (3101-301-002); NCT03700320 (long-term safety trial); NCT03939312 (open-label extension trial); NCT03855137 (3101-303-002).

Keywords: Body mass index; CGRP; gepant; migraine; migraine prevention; obesity.

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Conflict of interest statement

Declaration of conflicting interestsThe authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: B.L.P. has served as a consultant and/or on the speaker bureaus for AbbVie, Amgen, Biohaven, Eli Lilly, GlaxoSmithKline, Impel, and Lundbeck Pharmaceuticals and has received research support from GlaxoSmithKline Pharmaceuticals, the Landsberger Foundation, Luitpold, and the National Institutes of Health. D.S.B. has no conflicts to report. J.A. has served as a consultant for AbbVie, Aeon, Dr. Reddy, Eli Lilly and Company, GlaxoSmithKline, Gore, Ipsen, Linpharma, Lundbeck, Merz, Neurolief, Pfizer, Satsuma, Scilex, Theranica, and Tonix; provided editorial services to Current Pain and Headache Reports, SELF, and Medscape; and received clinical trial support from Ipsen, Parema, and Satsuma. D.W.D. reports the following conflicts: (5-years): Consulting: Amgen, Atria, CapiThera Ltd., Cerecin, Ceruvia Lifesciences LLC, CoolTech, Ctrl M, Allergan, AbbVie, Biohaven, Escient, GlaxoSmithKline, Halion, Lundbeck, Eli Lilly, Novartis, Impel, Satsuma, Theranica, WL Gore, Genentech, Nocira, Perfood, Praxis, AYYA Biosciences, Revance, Pfizer. Honoraria: American Academy of Neurology, Headache Cooperative of the Pacific, Headache Cooperative of New England, Canadian Headache Society, MF Med Ed Research, Biopharm Communications, CEA Group Holding Company (Clinical Education Alliance LLC), Teva (speaking), Amgen Japan (speaking), Eli Lilly Canada (speaking), Lundbeck (speaking), Pfizer (speaking), Vector Psychometric Group, Clinical Care Solutions, CME Outfitters, Curry Rockefeller Group, DeepBench, Global Access Meetings, KLJ Associates, Academy for Continued Healthcare Learning, Majallin LLC, Medlogix Communications, Medica Communications LLC, MJH Lifesciences, Miller Medical Communications, WebMD Health/Medscape, Wolters Kluwer, Oxford University Press, Cambridge University Press. Non-profit board membership: American Brain Foundation, American Migraine Foundation, ONE Neurology, Precon Health Foundation, Global Patient Advocacy Coalition, Atria Health Collaborative, Atria Academy of Science and Medicine, Arizona Brain Injury Alliance, Domestic Violence HOPE Foundation/Panfila, CSF Leak Foundation. Research support: Department of Defense, National Institutes of Health, Henry Jackson Foundation, Sperling Foundation, American Migraine Foundation, Henry Jackson Foundation, Patient Centered Outcomes Research Institute (PCORI). Stock options/shareholder/patents/board of directors: Ctrl M (options), Aural analytics (options), Axon Therapeutics (board/options), ExSano (options), Palion (options), Keimon Medical (options), Man and Science, Healint (options), Theranica (options), Second Opinion/Mobile Health (options), Epien (options), Nocira (options), Matterhorn (shares), Ontologics (shares), King-Devick Technologies (options/board), Precon Health (options/board), ScotiaLyfe (board), EigenLyfe (options/board), AYYA Biosciences (options), Axon Therapeutics (options/board), Cephalgia Group (options/board), Atria Health (options/employee). Patent 17189376.1-1466:vTitle: Onabotulinum Toxin Dosage Regimen for Chronic Migraine Prophylaxis (Non-royalty bearing). Patent application submitted: Synaquell® (Precon Health). P.J.G. reports support for the present study and personal fees during the conduct of the study from AbbVie; a grant from Celgene; personal fees from Aeon Biopharma, Amgen, BioDelivery Sciences International, Inc., CoolTech LLC, Dr Reddy's, Eli Lilly, Epalex, Impel NeuroPharma, Lundbeck, Novartis, Praxis, Sanofi, Satsuma, ShiraTronics, Teva Pharmaceuticals, and Tremeau; personal fees for advice through Gerson Lehrman Group, Guidepoint, SAI Med Partners, and Vector Metric; fees for educational materials from CME Outfitters, Omnia Education, and WebMD; fees for publishing from Massachusetts Medical Society and Oxford University Press; and fees for medicolegal advice in headache. He has a patent for Magnetic stimulation for headache, which is licensed to eNeura without fee. Y.L., R.D.A.F., J.H.S., B.D., and J.M.T. are employees of AbbVie and may hold AbbVie stock.

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