阿托格潘在偏头痛预防性治疗期间的体重减轻：一项汇总分析。
Weight loss with atogepant during the preventive treatment of migraine: A pooled analysis.
作者信息
Peterlin B Lee, Bond Dale S, Ailani Jessica, Dodick David W, Liu Yingyi, De Abreu Ferreira Rosa, Smith Jonathan H, Dabruzzo Brett, Goadsby Peter J, Trugman Joel M
机构信息
Pennsylvania Headache Center, Camp Hill, PA, USA.
Penn State Health Milton S. Hershey Medical Center, Hershey, PA, USA.
出版信息
Cephalalgia. 2024 Dec;44(12):3331024241299753. doi: 10.1177/03331024241299753.
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/m (pooled episodic migraine [United States only]) and 25.0-25.5 kg/m (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).
背景
偏头痛与肥胖相关。这些分析评估了使用阿托格潘作为偏头痛预防性治疗时的体重变化。
方法
纳入了五项针对成年偏头痛患者的阿托格潘临床试验（一项2b/3期；四项3期）：三项为期12周的随机、安慰剂对照试验（发作性偏头痛：两项；慢性偏头痛：一项）；一项为期40周的开放标签扩展试验和一项为期52周的标准护理、随机、发作性偏头痛长期安全性试验。测量了体重相对于基线的变化。
结果
平均基线体重指数在30.0 - 30.7 kg/m（汇总的发作性偏头痛[仅美国]）和25.0 - 25.5 kg/m（慢性偏头痛[东亚、欧洲和北美]）之间。在汇总的发作性偏头痛安慰剂对照试验中，与安慰剂相比，每日一次服用60 mg阿托格潘的更多参与者在任何时间体重减轻≥7%（4.9%对2.8%），慢性偏头痛安慰剂对照试验中（5.8%对2.0%），以及汇总的开放标签扩展试验和长期安全性试验中（标准护理组[仅长期安全性]为24.0%对14.7%）。在安慰剂对照试验中，每日一次服用60 mg阿托格潘在第2周时出现体重减轻（汇总的发作性偏头痛：-0.32%；慢性偏头痛：-0.39%），在第12周时增加（汇总的发作性偏头痛：-1.02%；慢性偏头痛：-1.50%）；相比之下，安慰剂在第12周时体重增加（汇总的发作性偏头痛：+0.49%；慢性偏头痛：+0.10%）。在长期发作性偏头痛研究中，每日一次服用60 mg阿托格潘在第4周时出现体重减轻（长期安全性：-0.42%；开放标签扩展：-0.76%），在第40周时增加（长期安全性：-2.38%；开放标签扩展：-2.09%）。
结论
阿托格潘与适度的剂量和持续时间依赖性体重减轻相关。
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）。
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