Barbanti Piero, Carpay Johannes A, Kwong W Jacqueline, Ahmad Faiz, Boswell Diane
Department of Neurological Sciences, La Sapienza University, Rome, Italy.
Curr Med Res Opin. 2004 Dec;20(12):2021-9. doi: 10.1185/030079904X15200.
A new oral form of sumatriptan has been developed to facilitate tablet disintegration and drug dispersion and to mitigate the effects of gastric stasis that can accompany migraine.
To evaluate the effects on functional ability of the new fast disintegrating/rapid release formulation of sumatriptan.
Sumatriptan 50 mg (n = 137), 100 mg (n = 142), or placebo (n = 153) was administered early when pain was mild for the acute treatment of a single migraine attack in a randomized, double-blind, parallel-group, placebo-controlled clinical trial. For this report, main health-outcomes endpoints (which were secondary endpoints for this clinical trial that was primarily designed to assess pain-free efficacy) included functional ability measured through 2 h postdose on a 5-point scale and lost time equivalents, a composite measure of migraine-associated time missed from activities, and reduced effectiveness at activities through 24 h postdose.
Normal functional ability was restored in a significantly (p < 0.05) greater percentage of patients treated with sumatriptan than placebo beginning 45 min postdose for sumatriptan 100 mg and 1 h postdose for sumatriptan 50 mg. During the 24 h after initial dosing, the median (range) lost time equivalents for the combination of paid work activities and activities outside of paid work were significantly lower in the groups treated with sumatriptan (1.1 [0-10] sumatriptan 100 mg; 0.8 [0-36] sumatriptan 50 mg) compared with placebo (2.9 [0-24]) (p < or = 0.01 each sumatriptan group versus placebo). The corresponding mean +/- SD values for lost time equivalents were 1.9 +/- 2.3 and 2.5 +/- 4.7 for sumatriptan 100 mg and 50 mg, respectively, compared with 3.5 +/- 4.3 for placebo.
A new oral sumatriptan formulation confers rapid, sustained restoration of functional ability in the acute treatment of migraine so that patients can return rapidly to normal functioning at work and outside of work.
已研发出一种新的口服舒马曲坦剂型，以促进片剂崩解和药物分散，并减轻偏头痛可能伴随的胃潴留影响。
评估舒马曲坦新的快速崩解/速释制剂对功能能力的影响。
在一项随机、双盲、平行组、安慰剂对照的临床试验中，当疼痛轻微时尽早给予50mg舒马曲坦（n = 137）、100mg舒马曲坦（n = 142）或安慰剂（n = 153），用于急性治疗单次偏头痛发作。对于本报告，主要健康结局终点（在这项主要旨在评估无痛疗效的临床试验中为次要终点）包括给药后2小时内通过5分制测量的功能能力以及失时当量，失时当量是偏头痛相关活动时间缺失的综合指标，以及给药后24小时内活动效率降低情况。
从100mg舒马曲坦给药后45分钟和50mg舒马曲坦给药后1小时开始，接受舒马曲坦治疗的患者恢复正常功能能力的百分比显著高于安慰剂组（p < 0.05）。在首次给药后的24小时内，舒马曲坦治疗组（100mg舒马曲坦为1.1 [0 - 10]；50mg舒马曲坦为0.8 [0 - 36]）的有偿工作活动和有偿工作以外活动组合的失时当量中位数（范围）显著低于安慰剂组（2.9 [0 - 24]）（各舒马曲坦组与安慰剂组相比，p≤0.01）。100mg和50mg舒马曲坦失时当量的相应均值±标准差分别为1.9±2.3和2.5±4.7，而安慰剂组为3.5±4.3。
一种新的口服舒马曲坦制剂在偏头痛急性治疗中能快速、持续恢复功能能力，使患者能够迅速恢复正常的工作和非工作状态。
