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

IF 5 2区医学 Q1 CLINICAL NEUROLOGY

Cephalalgia Pub Date : 2024-12-01 DOI:10.1177/03331024241299753

B Lee Peterlin, Dale S Bond, Jessica Ailani, David W Dodick, Yingyi Liu, Rosa De Abreu Ferreira, Jonathan H Smith, Brett Dabruzzo, Peter J Goadsby, Joel M Trugman

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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).

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来源期刊

Cephalalgia 医学-临床神经学

CiteScore

10.10

自引率

6.10%

发文量

108

审稿时长

4-8 weeks

期刊介绍： Cephalalgia contains original peer reviewed papers on all aspects of headache. The journal provides an international forum for original research papers, review articles and short communications. Published monthly on behalf of the International Headache Society, Cephalalgia''s rapid review averages 5 ½ weeks from author submission to first decision.