Wesley Headache Clinic, Memphis, TN, USA
Ther Adv Neurol Disord. 2009 May;2(3):135-41. doi: 10.1177/1756285609102769.
A novel composite endpoint, sustained pain-free/no adverse events, was recently proposed as a more rigorous means of capturing in a single measure the attributes of migraine pharmacotherapy that patients consider most important: rapid and sustained pain-free response with no side-effects. Using pooled data from two replicate randomized, double-blind, parallel-group, placebo-controlled studies, this post hoc analysis compared the fixed-dose combination tablet sumatriptan/naproxen sodium (n = 726) with sumatriptan monotherapy (n = 723), naproxen sodium monotherapy (n = 720), and placebo (n = 742) with respect to sustained pain-free/no adverse events and closely related composite measures. Sustained pain-free/no adverse events was defined as having both a sustained pain-free response from 2 through 24 hours post-dose with no use of rescue medication and having no adverse events within up to 5 days after dosing with study medication. The percentage of patients with sustained pain-free/no adverse events was 16% with sumatriptan/naproxen sodium compared with 11%, 9% and 7% for sumatriptan, naproxen sodium and placebo, respectively (p<0.01 sumatriptan/naproxen sodium versus each other treatment). Sumatriptan/naproxen sodium was also significantly more effective than sumatriptan, naproxen sodium, and placebo for other composite endpoints including the percentages of patients with (1) sustained pain-free/no adverse events within 1 day; (2) sustained pain-free/no drug-related adverse events within up to 5 days; (3) sustained pain-free/no drug-related adverse events within 1 day; (4) sustained pain relief/no adverse events within up to 5 days; and (5) sustained pain relief/no adverse events within 1 day. The results demonstrate the superiority of sumatriptan/naproxen sodium to sumatriptan monotherapy, naproxen sodium monotherapy and placebo with respect to the rigorous and clinically relevant endpoint of sustained pain-free/no adverse events and reinforce the usefulness of utilizing this new composite endpoint.
一种新的复合终点，持续无疼痛/无不良事件，最近被提议作为一种更严格的方法，以单一措施捕捉偏头痛药物治疗的属性，患者认为最重要的是：快速和持续无疼痛反应，无副作用。使用来自两项复制的随机、双盲、平行组、安慰剂对照研究的汇总数据，这项事后分析比较了固定剂量组合片剂舒马曲坦/萘普生钠（n = 726）与舒马曲坦单药治疗（n = 723）、萘普生钠单药治疗（n = 720）和安慰剂（n = 742）在持续无疼痛/无不良事件和密切相关的复合指标方面的情况。持续无疼痛/无不良事件定义为在给药后 2 至 24 小时内既有持续无疼痛反应，无需使用解救药物，且在使用研究药物后 5 天内无不良事件。舒马曲坦/萘普生钠组的持续无疼痛/无不良事件发生率为 16%，而舒马曲坦、萘普生钠和安慰剂组分别为 11%、9%和 7%（p<0.01 舒马曲坦/萘普生钠与其他治疗组相比）。舒马曲坦/萘普生钠在其他复合终点方面也显著优于舒马曲坦、萘普生钠和安慰剂，包括以下患者比例：（1）在 1 天内持续无疼痛/无不良事件；（2）在最多 5 天内持续无疼痛/无药物相关不良事件；（3）在 1 天内持续无疼痛/无药物相关不良事件；（4）在最多 5 天内持续疼痛缓解/无不良事件；以及（5）在 1 天内持续疼痛缓解/无不良事件。这些结果表明，舒马曲坦/萘普生钠在严格和临床相关的持续无疼痛/无不良事件终点方面优于舒马曲坦单药治疗、萘普生钠单药治疗和安慰剂，并且强化了利用这种新的复合终点的有用性。
