Merck Research Laboratories, USA.
Cephalalgia. 2010 Dec;30(12):1443-57. doi: 10.1177/0333102410370878. Epub 2010 Jun 8.
This study evaluated the calcitonin gene-related peptide (CGRP) receptor antagonist telcagepant (tablet formulation) for treatment of a migraine attack and across four attacks. Adults with migraine were randomized, double-blind, to telcagepant 140 mg, telcagepant 280 mg, or control treatment sequences to treat four moderate-to-severe migraine attacks. Control patients received placebo for three attacks and telcagepant 140 mg for one attack. Efficacy for the first attack (Attack 1) and consistency of efficacy over multiple attacks were assessed. For an individual patient, consistent efficacy was defined as ≥ 3 successes, and lack of consistent efficacy was defined as ≥ 2 failures, in treatment response. A total of 1677 patients treated ≥ 1 attack and 1263 treated all four attacks.
Based on Attack 1 data, telcagepant 140 mg and 280 mg were significantly (p < .001) more effective than placebo for 2-hour pain freedom, 2-hour pain relief, 2-hour absence of migraine-associated symptoms (phonophobia, photophobia, nausea), and 2-24 hours sustained pain freedom. The percentage of patients with 2-hour pain freedom consistency and 2-hour pain relief consistency was significantly (p < .001) higher for both telcagepant treatment sequences versus control. Adverse events within 48 hours for telcagepant with an incidence ≥ 2% and twice that of placebo were somnolence (placebo = 2.3%, 140 mg = 5.9%, 280 mg = 5.7%) and vomiting (placebo = 1.4%, 140 mg = 1.0%, 280 mg = 2.9%).
Telcagepant 140 mg and 280 mg were effective for treatment of a migraine attack and were more consistently effective than control for intermittent treatment of up to four migraine attacks. Telcagepant was generally well tolerated. (Clinicaltrials.gov; NCT00483704).
本研究评估了降钙素基因相关肽（CGRP）受体拮抗剂 telcagepant（片剂制剂）治疗偏头痛发作和四次发作的疗效。偏头痛患者被随机、双盲分组，接受 telcagepant 140mg、telcagepant 280mg 或对照治疗序列治疗四次中重度偏头痛发作。对照患者前三次于治疗时接受安慰剂，第四次于治疗时接受 telcagepant 140mg。评估首次发作（发作 1）和多次发作的疗效一致性。对于个体患者，如果在治疗反应中≥3 次成功且≥2 次失败，则定义为疗效一致；如果≥2 次成功且≥2 次失败，则定义为疗效不一致。共有 1677 例患者治疗了≥1 次发作，1263 例患者治疗了所有 4 次发作。
根据发作 1 数据，telcagepant 140mg 和 280mg 与安慰剂相比，在 2 小时疼痛缓解、2 小时无偏头痛相关症状（恐声症、畏光症、恶心）、2-24 小时持续疼痛缓解方面有显著差异（p <.001）。与对照相比，telcagepant 两种治疗方案的 2 小时疼痛缓解率一致性和 2 小时疼痛缓解率一致性的比例显著（p <.001）更高。telcagepant 治疗组 48 小时内发生率≥2%且是安慰剂组两倍的不良事件有嗜睡（安慰剂=2.3%，140mg=5.9%，280mg=5.7%）和呕吐（安慰剂=1.4%，140mg=1.0%，280mg=2.9%）。
telcagepant 140mg 和 280mg 对偏头痛发作有效，与对照相比，在 4 次间歇性偏头痛治疗中更一致有效。telcagepant 总体耐受性良好。（临床试验.gov；NCT00483704）。
