Winner Paul, Linder Steven L, Lipton Richard B, Almas Mary, Parsons Bruce, Pitman Verne
Nova Southeastern University, Fort Lauderdale, FL 33407, USA.
Headache. 2007 Apr;47(4):511-8. doi: 10.1111/j.1526-4610.2007.00755.x.
Eletriptan is a potent 5-HT(1B/1D) agonist with proven efficacy in the acute treatment of migraine in adults.
To evaluate the efficacy and tolerability of eletriptan 40 mg versus placebo in adolescent patients (aged 12-17).
A multicenter, double-blind, parallel-group, placebo-controlled trial was conducted comparing 40 mg of oral eletriptan with placebo for the treatment of migraine in adolescent patients. The primary efficacy endpoint was 2-hour headache response, and a number of secondary endpoints were also evaluated. An exploratory analysis evaluated which clinical and demographic characteristics might be correlated with high placebo response.
Of 274 patients who treated a migraine attack, 267 were evaluated for efficacy (n = 138 eletriptan; n = 129 placebo) at 2 hours post-dose. There was no significant difference in 2-hour headache response for eletriptan 40 mg versus placebo (57% vs 57%), and no significant improvements were observed for any of the outcomes at 1 or 2 hours post-dose. By contrast, there was a significant advantage for eletriptan 40 mg in reducing headache recurrence within 24 hours post-dose (11% vs 25%, P= .028), and post hoc analyses showed statistically significant differences for sustained headache response rates (52% vs 39%; P= .04) and sustained pain-free response rates (22% vs 10%; P= .013). The strongest clinical predictor of placebo response was triptan-naïve status (i.e., no previous use of any triptan). Eletriptan 40 mg was well tolerated in this population, and the profile of adverse events was similar to that observed in Phase III trials in adult patients.
The high placebo response rates reported here for 1- and 2-hour outcomes are in accordance with other studies of triptans in adolescent patients. The evaluation of treatment effect in adolescent migraine might benefit from use of more stringent outcome measures, such as headache recurrence, sustained headache response, and sustained pain-free response at 24 hours post-dose.
依立曲坦是一种强效的5-HT(1B/1D)激动剂，已证实对成人偏头痛的急性治疗有效。
评估40毫克依立曲坦与安慰剂对青少年患者（12至17岁）的疗效和耐受性。
进行了一项多中心、双盲、平行组、安慰剂对照试验，比较40毫克口服依立曲坦与安慰剂治疗青少年偏头痛的效果。主要疗效终点为2小时头痛缓解情况，还评估了多个次要终点。一项探索性分析评估了哪些临床和人口统计学特征可能与高安慰剂反应相关。
在274例治疗偏头痛发作的患者中，267例在给药后2小时进行了疗效评估（依立曲坦组n = 138；安慰剂组n = 129）。40毫克依立曲坦与安慰剂在2小时头痛缓解情况上无显著差异（57%对57%），给药后1小时或2小时的任何结果均未观察到显著改善。相比之下，40毫克依立曲坦在给药后24小时内减少头痛复发方面具有显著优势（11%对25%，P = 0.028），事后分析显示在持续头痛缓解率（52%对39%；P = 0.04）和持续无痛缓解率（22%对10%；P = 0.013）方面存在统计学显著差异。安慰剂反应最强的临床预测因素是未使用过曲坦类药物（即以前未使用过任何曲坦类药物）。40毫克依立曲坦在该人群中耐受性良好，不良事件谱与在成年患者的III期试验中观察到的相似。
此处报告的1小时和2小时结果的高安慰剂反应率与其他关于青少年患者曲坦类药物的研究一致。对青少年偏头痛治疗效果的评估可能受益于使用更严格的结局指标，如头痛复发、持续头痛缓解和给药后24小时的持续无痛缓解。
