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ubrogepant治疗偏头痛
Ubrogepant for the Treatment of Migraine


David W. Dodick ... 其他 • 2019.12.05
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• 口服降钙素基因相关肽受体拮抗剂rimegepant治疗偏头痛 • erenumab治疗发作性偏头痛的对照临床试验

摘要


背景

ubrogepant是一种用于治疗急性偏头痛的口服小分子降钙素基因相关肽受体拮抗剂。

 

方法

我们开展了一项评价ubrogepant疗效、安全性和副作用的随机试验。本试验以1∶1∶1的比例将有或无先兆的成人偏头痛患者随机分组,分别接受初始剂量的安慰剂、50 mg剂量的ubrogepant或100 mg剂量的ubrogepant,用于治疗单次偏头痛发作,并且患者可选择接受第二剂治疗。联合主要疗效终点是在首剂给药后2小时无疼痛,以及在2小时无最烦人的偏头痛相关症状。次要终点包括疼痛缓解(在2小时)、持续疼痛缓解(2~24小时)、持续无疼痛(2~24小时)以及在2小时无偏头痛相关症状(畏光、畏声和恶心)。

 

结果

本试验共纳入了1,672例参与者;559例被分配接受安慰剂治疗,556例接受50 mg ubrogepant治疗,557例接受100 mg ubrogepant治疗。在安慰剂组、50 mg ubrogepant组和100 mg ubrogepant组中,在2小时无疼痛的参与者百分比分别为11.8%、19.2%(多重校正后,与安慰剂相比,P=0.002)和21.2%(P<0.001)。在上述三组中,在2小时无最烦人的症状的参与者百分比分别为27.8%、38.6%(P=0.002)和37.7%(P=0.002)。在上述三组中,分别有12.8%、9.4%和16.3%的参与者在首剂或可选的第二剂给药后48小时内报告了不良事件。最常见的不良事件为恶心、嗜睡和口干(报告的发生率,0.4%~4.1%);100 mg ubrogepant组的上述事件发生率较高(报告的发生率,2.1%~4.1%)。ubrogepant组30日内报告的严重不良事件包括阑尾炎、自然流产、心包积液和惊厥发作;上述事件的发生时间均不在给药后48小时内。

 

结论

在接受ubrogepant治疗的参与者中,在给药后2小时无疼痛和无最烦人(most bothersome)的症状的比例高于接受安慰剂治疗的参与者。最常报告的不良事件为恶心、嗜睡和口干。我们需要通过进一步试验来确定ubrogepant治疗急性偏头痛的疗效持久性和安全性,并将ubrogepant与偏头痛的其他治疗药物进行比较(由艾尔建公司资助;在ClinicalTrials.gov注册号为NCT02828020)。





作者信息

David W. Dodick, M.D., Richard B. Lipton, M.D., Jessica Ailani, M.D., Kaifeng Lu, Ph.D., Michelle Finnegan, M.P.H., Joel M. Trugman, M.D., and Armin Szegedi, M.D.
From the Mayo Clinic, Phoenix, AZ (D.W.D.); Albert Einstein College of Medicine and Montefiore Headache Center, Bronx, NY (R.B.L.); Georgetown University Hospital, Washington, DC (J.A.); and Allergan, Madison, NJ (K.L., M.F., J.M.T., A.S.). Address reprint requests to Dr. Dodick at the Mayo Clinic, Department of Neurology, 5777 E. Mayo Blvd., Phoenix, AZ 85054, or at dodick.david@mayo.edu.

 

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