Dodick David W
Department of Neurology, Mayo Clinic Scottsdale, Ariz 85259, USA.
Headache. 2002 Jan;42(1):21-7. doi: 10.1046/j.1526-4610.2002.02009.x.
Evaluate the effect of almotriptan on sustained pain-free outcome in patients with acute migraine.
Three randomized, double-blind, placebo-controlled trials of almotriptan for the treatment of acute migraine were examined. Two trials evaluated almotriptan 6.25 mg and 12.5 mg, and the third evaluated almotriptan 12.5 mg and sumatriptan 100 mg. Patients aged 18 to 65 years were instructed to take 1 dose of study medication at the onset of a moderate-to-severe migraine headache. A second dose was allowed for relapse. Sustained pain-free was defined as a decrease in pain severity from moderate or severe at baseline to no pain at 2 hours postdose and without relapse or the use of escape medication between 2 and 24 hours.
A total of 1791 adult migraine sufferers were studied. The proportion of patients achieving a sustained pain-free state was significantly (P<.05) higher in the almotriptan 6.25-mg (21.7% to 22.5%) and 12.5-mg (24.6% to 27.6%) groups than in the placebo group (7.5% to 12.1%). The proportion of patients achieving a sustained pain-free state was comparable between almotriptan 12.5 mg (24.6%) and sumatriptan 100 mg (28.5%) and significantly (P<.05) greater than with placebo (12.1%). Among patients with severe baseline pain, a sustained pain-free state was achieved in significantly more patients (P<.05) with almotriptan 12.5 mg (17.3% to 20.9%) than with placebo (3.1% to 3.2%). Among those with moderate baseline pain, a sustained pain-free state was achieved in significantly more patients (P<.01) with almotriptan 12.5 mg (31.3% to 32.0%) than with placebo (10.2% to 16.1%).
Almotriptan 12.5 mg is significantly better than placebo and comparable to sumatriptan 100 mg for achieving a sustained pain-free state.
评估阿莫曲坦对急性偏头痛患者持续无痛结局的影响。
对三项阿莫曲坦治疗急性偏头痛的随机、双盲、安慰剂对照试验进行了研究。两项试验评估了6.25毫克和12.5毫克的阿莫曲坦，第三项试验评估了12.5毫克的阿莫曲坦和100毫克的舒马曲坦。年龄在18至65岁的患者被指示在中度至重度偏头痛发作时服用一剂研究药物。复发时允许服用第二剂。持续无痛定义为疼痛严重程度从基线时的中度或重度降至服药后2小时无疼痛，且在2至24小时内无复发或未使用解救药物。
共研究了1791名成年偏头痛患者。在6.25毫克（21.7%至22.5%）和12.5毫克（24.6%至27.6%）的阿莫曲坦组中，达到持续无痛状态的患者比例显著高于安慰剂组（7.5%至12.1%）（P<0.05）。12.5毫克的阿莫曲坦组（24.6%）和100毫克的舒马曲坦组（28.5%）达到持续无痛状态的患者比例相当，且显著高于安慰剂组（12.1%）（P<0.05）。在基线疼痛严重的患者中，服用12.5毫克阿莫曲坦的患者达到持续无痛状态的比例显著高于安慰剂组（P<0.05）（17.3%至20.9%对3.1%至3.2%）。在基线疼痛中度的患者中，服用12.5毫克阿莫曲坦的患者达到持续无痛状态的比例显著高于安慰剂组（P<0.01）（31.3%至32.0%对10.2%至16.1%）。
12.5毫克的阿莫曲坦在实现持续无痛状态方面显著优于安慰剂，且与100毫克的舒马曲坦相当。
