BI 44370 TA，一种用于治疗急性偏头痛发作的口服 CGRP 拮抗剂：来自 II 期研究的结果。
BI 44370 TA, an oral CGRP antagonist for the treatment of acute migraine attacks: results from a phase II study.
机构信息
Department of Neurology and Headache Center, University Hospital Essen, University Duisburg-Essen, Hufelandstrasse 55, Essen, Germany.
出版信息
Cephalalgia. 2011 Apr;31(5):573-84. doi: 10.1177/0333102410388435. Epub 2010 Dec 20.
METHODS
Four hundred and sixty-one adult subjects with migraine were randomised to one of five treatments, the oral antagonist at the calcitonin gene-related peptide (CGRP) receptor BI 44370 TA (50 mg, 200 mg, 400 mg), active comparator eletriptan 40 mg or placebo. The analysis included 341 subjects who took study medication.
RESULTS
The primary endpoint, pain-free after two hours, was reached by significantly more subjects in the BI 44370 TA 400 mg (20/73 = 27.4%) and eletriptan 40 mg (24/69 = 34.8%) groups compared to placebo (6/70 = 8.6%, p = .0016), but not by subjects in the BI 44370 TA 200 mg group (14/65 = 21.5%). The effect of 50 mg BI 44370 TA (5/64 = 7.8%) was similar to that of placebo. Analysis of secondary endpoints supported the conclusion from the primary analysis. The frequency of adverse events was low in all groups.
CONCLUSION
Efficacy of BI 44370 TA was shown in a dose-dependent manner in the treatment of acute migraine attacks.
方法
461 例成年偏头痛患者被随机分为 5 种治疗组之一，即降钙素基因相关肽（CGRP）受体拮抗剂 BI 44370 TA（50mg、200mg、400mg）、活性对照药依来曲普坦 40mg 或安慰剂。该分析包括 341 例服用研究药物的患者。
结果
主要终点为 2 小时后无痛，BI 44370 TA 400mg（20/73=27.4%）和依来曲普坦 40mg（24/69=34.8%）组较安慰剂（6/70=8.6%，p=0.0016）组达到无疼痛的患者明显更多，但 BI 44370 TA 200mg 组（14/65=21.5%）无差异。BI 44370 TA 50mg（5/64=7.8%）的疗效与安慰剂相似。次要终点分析支持主要分析的结论。所有组的不良事件发生率均较低。
结论
BI 44370 TA 的疗效呈剂量依赖性，可用于治疗急性偏头痛发作。
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