依立曲坦在初用曲坦类药物患者中的疗效：一项合并分析结果

Efficacy of eletriptan in triptan-naïve patients: results of a combined analysis.

作者信息

Martin Vincent T, Valade Dominique, Almas Mary, Hettiarachchi Jayasena, Sikes Carolyn, Albert Kenneth S, Parsons Bruce

机构信息

Division of General Internal Medicine, University of Cincinnati, Cincinnati, OH 45267-4217, USA.

出版信息

Headache. 2007 Feb;47(2):181-8. doi: 10.1111/j.1526-4610.2006.00685.x.

DOI:10.1111/j.1526-4610.2006.00685.x

PMID:17300357

Abstract

OBJECTIVE

To compare the efficacy and tolerability of eletriptan 20 mg, 40 mg, and 80 mg in triptan-naïve patients (who have not previously used triptans) versus triptan-experienced patients (who have previously used triptans).

METHODS

Efficacy and tolerability data for eletriptan 20 mg, 40 mg, and 80 mg were pooled from 10 similarly designed, randomized, parallel-group studies, and triptan-naïve and triptan-experienced patients were compared with placebo across the 3 triptan doses. The primary efficacy endpoint was headache response at 2 hours postdose. Secondary efficacy endpoints were 2-hour pain-free response, 2-hour absence of associated symptoms, 2-hour functional response, 24-hour sustained headache response, and 24-hour sustained pain-free response.

RESULTS

For eletriptan 20 mg, 40 mg, and 80 mg versus placebo, respectively, triptan-naïve patients showed significantly higher 2-hour headache response (54%, 61%, 66% vs. 31%; P < .0001), 2-hour pain-free response (20%, 28%, and 31% vs. 8%; P < .0001), and 24-hour sustained headache response (34%, 45%, and 51% vs. 20%; P < .0001). A similarly significant efficacy advantage was also observed in the triptan-experienced subgroup for 2-hour headache response (46%, 63%, 69% vs. 21%; P < .0001), 2-hour pain-free response (13%, 32%, and 38% vs. 4%; P < .0001), and 24-hour sustained headache response (29%, 41%, and 45% vs. 9%; P < .0001). Previous treatment status did not influence tolerability, and all 3 doses of eletriptan were well tolerated.

CONCLUSIONS

These data suggest that eletriptan has comparable efficacy versus placebo among both triptan-naïve and triptan-experienced patients.

摘要

目的

比较20毫克、40毫克和80毫克依立曲坦在初用曲坦类药物患者（此前未使用过曲坦类药物）与曾用曲坦类药物患者（此前使用过曲坦类药物）中的疗效和耐受性。

方法

汇总10项设计相似的随机平行组研究中20毫克、40毫克和80毫克依立曲坦的疗效和耐受性数据，将初用曲坦类药物和曾用曲坦类药物的患者在3种曲坦类药物剂量下与安慰剂进行比较。主要疗效终点为给药后2小时的头痛缓解情况。次要疗效终点为2小时无痛缓解、2小时无相关症状、2小时功能改善、24小时持续头痛缓解及24小时持续无痛缓解。

结果

与安慰剂相比，对于20毫克、40毫克和80毫克依立曲坦，初用曲坦类药物的患者在给药后2小时的头痛缓解率显著更高（分别为54%、61%、66%对31%；P <.0001），2小时无痛缓解率（分别为20%、28%和31%对8%；P <.0001），以及24小时持续头痛缓解率（分别为34%、45%和51%对20%；P <.0001）。在曾用曲坦类药物的亚组中，对于给药后2小时的头痛缓解率（分别为46%、63%、69%对21%；P <.0001），2小时无痛缓解率（分别为13%、32%和38%对4%；P <.0001），以及24小时持续头痛缓解率（分别为29%、41%和45%对9%；P <.0001），也观察到了类似的显著疗效优势。既往治疗状态不影响耐受性，所有3种剂量的依立曲坦耐受性均良好。