Mathew Ninan T
Houston (Tex) Headache Clinic, 77004, USA.
Headache. 2002 Jan;42(1):32-40. doi: 10.1046/j.1526-4610.2002.02011.x.
Evaluate the long-term tolerability of almotriptan 12.5 mg for the treatment of acute migraine attacks occurring over a 6-month period.
Almotriptan is a second-generation 5-HT(1B/1D) agonist that exhibits vascular selectivity for meningeal arteries and has demonstrated efficacy for the treatment of acute migraine in short-term controlled trials.
This was a 6-month open-label study. Adults (18 years of age or older) were required to have a diagnosis of acute migraine with or without aura (according to the diagnostic criteria of the International Headache Society), a history of at least 1 year of moderate-to-severe migraine pain with at least two and a maximum of six migraines per month, and at least 24 hours of freedom from head pain between attacks. Patients were instructed to take a single 12.5-mg dose of almotriptan at the onset of a migraine attack. If migraine pain did not disappear in 2 hours, escape medication could be taken; if relapse occurred in less than 24 hours, a second 12.5-mg dose could be taken. Tolerability was assessed from the nature and incidence of all adverse events, and efficacy was assessed according to the end point of pain relief 2 hours following almotriptan administration.
Of 585 patients treated, 582 were included in the intent-to-treat population. The most frequent drug-related adverse events were nausea (3.1%) and dizziness (2.4%). No serious drug-related adverse events were reported, and no deaths occurred. Adverse events led to discontinuation of treatment in 36 patients (6.2%). Drug-related chest pain was reported in 9 patients (1.5%). Seventy-six percent of patients achieved pain relief at 2 hours for all attacks treated, and 49% were pain-free at 2 hours. After a second dose of almotriptan 12.5 mg, pain relief was achieved in 87% of attacks, and 59% were pain-free. Pain relief and pain-free rates were higher among those with moderate baseline pain.
When taken at attack onset, almotriptan 12.5 mg is well tolerated, safe, and effective for the long-term treatment of acute migraine.
评估12.5毫克阿莫曲坦治疗6个月期间发生的急性偏头痛发作的长期耐受性。
阿莫曲坦是第二代5-HT(1B/1D)激动剂，对脑膜动脉具有血管选择性，并且在短期对照试验中已证明对治疗急性偏头痛有效。
这是一项为期6个月的开放标签研究。成人（18岁及以上）需要诊断为伴有或不伴有先兆的急性偏头痛（根据国际头痛协会的诊断标准），有至少1年中度至重度偏头痛疼痛病史，每月至少发作2次且最多6次偏头痛，且发作之间至少有24小时无头痛。患者被指示在偏头痛发作开始时服用单次12.5毫克剂量的阿莫曲坦。如果偏头痛疼痛在2小时内未消失，可以服用解救药物；如果在不到24小时内复发，可以服用第二剂12.5毫克。根据所有不良事件的性质和发生率评估耐受性，并根据服用阿莫曲坦后2小时疼痛缓解的终点评估疗效。
在接受治疗的585名患者中，582名被纳入意向性治疗人群。最常见的药物相关不良事件是恶心（3.1%）和头晕（2.4%）。未报告严重的药物相关不良事件，也未发生死亡。不良事件导致36名患者（6.2%）停药。9名患者（1.5%）报告了药物相关胸痛。76%的患者在治疗的所有发作中2小时时实现了疼痛缓解，49%的患者在2小时时无疼痛。在服用第二剂12.5毫克阿莫曲坦后，87%的发作实现了疼痛缓解，59%的患者无疼痛。基线疼痛为中度的患者中疼痛缓解率和无疼痛率更高。
在发作开始时服用，12.5毫克阿莫曲坦耐受性良好、安全且对急性偏头痛的长期治疗有效。
