为期六个月的开放标签研究中评估口服舒马曲坦急性治疗偏头痛的患者选择剂量。舒马曲坦片S2CM10研究组。

A J Dowson, E A Ashford, S Prendergast, H Hassani, G W Roberts, T Flöter, A Szczudlik
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引用次数: 0

摘要

背景:口服舒马曲坦作为偏头痛急性治疗的推荐剂量从25mg到100mg不等。患者的剂量偏好尚未在模拟临床实践的环境中进行研究。方法:在一项开放标签研究中,评估患者接受25mg、50mg和100mg口服舒马普坦6个月的相对疗效和安全性,338例患者用50mg舒马普坦治疗3次偏头痛发作,然后允许剂量加倍或减半。在治疗了另外三次发作后,他们再次被允许将剂量调整一个水平。结果:偏头痛发作3次后,37%的患者选择继续50mg剂量,50%的患者选择增加剂量至100mg, 12%的患者选择减少剂量至25mg。发作后,分别有6,8%,33%和58%的患者选择25mg, 50mg和100mg的剂量;服用100毫克剂量的人中,只有3%的人选择减少剂量。总的来说,每名患者在给药4小时后头痛缓解的平均发作百分比分别为71%,71%和80%,分别为25mg, 50mg和100mg剂量。在第3次发作后将剂量减少到25毫克的患者,其不良事件和头痛缓解发作的百分比都有所减少,而将剂量增加到100毫克的患者,头痛缓解的可能性增加了,但不良事件的发生率没有增加。结论:选择50mg或100mg剂量的患者多于25mg剂量的患者。三种剂量的疗效和耐受性相似。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Patient-selected dosing in a six-month open-label study evaluating oral sumatriptan in the acute treatment of migraine. Sumatriptan Tablets S2CM10 Study Group.

Background: Dosing recommendations for oral sumatriptan as acute treatment for migraine have ranged from 25 mg to 100 mg. Patient dose preferences have not been studied in a setting mimicking clinical practice.

Methods: In an open-label study evaluating patient acceptance and the relative efficacy and safety of 25 mg, 50 mg, and 100 mg doses of oral sumatriptan over a period of six months, 338 patients treated three migraine attacks with 50 mg sumatriptan and then were allowed to double or halve the dose. After treating another three attacks, they were again allowed to adjust the dose by one level.

Results: After migraine attack 3, 37% of patients chose to continue with the 50 mg dose, 50% increased the dose to 100 mg, and 12% decreased it to 25 mg. After attack 6, 8%, 33%, and 58% of patients chose the 25 mg, 50 mg, and 100 mg doses, respectively; only 3% of those taking the 100 mg dose chose to reduce it. Overall, the mean percentages of attacks per patient in which headache relief had been obtained 4 h after dosing were 71%, 71%, and 80% for the 25 mg, 50 mg, and 100 mg doses, respectively. Patients who decreased the dose to 25 mg after attack 3 experienced decreases both in adverse events and percentage of attacks with headache relief, whereas in those who increased the dose to 100 mg, likelihood of headache relief increased but the incidence of adverse events did not.

Conclusions: More patients chose the 50 mg or 100 mg dose than the 25 mg dose. All three doses had similar efficacy and tolerability.

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