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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Change from baseline in body weight was measured.</p><p><strong>Results: </strong>Mean baseline body mass indexes were 30.0-30.7 kg/m<sup>2</sup> (pooled episodic migraine [United States only]) and 25.0-25.5 kg/m<sup>2</sup> (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%).</p><p><strong>Conclusion: </strong>Atogepant was associated with modest dose- and duration-dependent weight loss.</p><p><strong>Trial registration: </strong>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).</p>","PeriodicalId":10075,"journal":{"name":"Cephalalgia","volume":"44 12","pages":"3331024241299753"},"PeriodicalIF":5.0000,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Weight loss with atogepant during the preventive treatment of migraine: A pooled analysis.\",\"authors\":\"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\",\"doi\":\"10.1177/03331024241299753\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Migraine is associated with obesity. 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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%). 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引用次数: 0
摘要
背景：偏头痛与肥胖有关。这些分析评估了服用抗偏头痛剂作为预防性偏头痛治疗的体重变化。方法：在成人偏头痛患者中进行5项相关药物临床试验(1项2b/3期；包括4项3期试验：3项为期12周的随机安慰剂对照试验(发作性偏头痛：2项；慢性偏头痛：1)；一项针对发作性偏头痛的40周开放标签扩展试验和一项52周标准治疗随机长期安全性试验。测量体重与基线的变化。结果：平均基线体重指数为30.0-30.7 kg/m2（合并发作性偏头痛[仅限美国]）和25.0-25.5 kg/m2（慢性偏头痛[东亚、欧洲和北美]）。在合并发作性偏头痛安慰剂对照试验（4.9% vs. 2.8%）、慢性偏头痛安慰剂对照试验（5.8% vs. 2.0%）和合并开放标签扩展和长期安全性试验（24.0% vs.14.7%标准治疗[仅长期安全性]）中，与安慰剂相比，更多的受试者在任何时候体重减轻≥7%。在安慰剂对照试验中，在第2周观察到服用60 mg每日一次的增重剂体重减轻(合并发作性偏头痛：-0.32%；慢性偏头痛：-0.39%)，在第12周增加(合并发作性偏头痛：-1.02%；慢性偏头痛：-1.50%)；与安慰剂组在第12周的体重增加相比(合并发作性偏头痛：+0.49%；慢性偏头痛：+0.10%)。在长期发作性偏头痛的研究中，在第4周观察到使用ategat60mg每日一次的体重减轻(长期安全性：-0.42%；开放标签延长：-0.76%)，在第40周增加(长期安全性：-2.38%；开放标签扩展：-2.09%)。结论：阿佐格坦与适度剂量依赖性和持续时间依赖性体重减轻有关。试验注册：ClinicalTrials.gov标识符：NCT02848326 (CGP-MD-01)；NCT03777059 (3101-301-002);NCT03700320（长期安全性试验）；NCT03939312（开放标签扩展试验）；NCT03855137(3101-303-002)。
Weight loss with atogepant during the preventive treatment of migraine: A pooled analysis.
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.
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.
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