New England Institute for Neurology and Headache, Stamford, CT, USA.
California Medical Clinic for Headache, Santa Monica, CA, USA.
Cephalalgia. 2022 Sep;42(10):1005-1012. doi: 10.1177/03331024221089567. Epub 2022 Mar 25.
To examine changes in the occurrence, severity, and symptoms of headache episodes in patients with chronic migraine following eptinezumab treatment.
PROMISE-2 was a double-blind, placebo-controlled, parallel-group trial that randomized adults with chronic migraine to eptinezumab 100 mg, 300 mg, or placebo IV every 12 weeks for up to 24 weeks (2 infusions). Headache episodes (migraine and non-migraine) and their characteristics were reported in daily electronic diaries during the 28-day baseline and throughout the 24-week treatment period.
A total of 1072 patients were included in this post hoc analysis. Mean monthly headache days decreased by 8.9 (100 mg) and 9.7 (300 mg) compared to a 7.3 decrease in placebo over the first 4-week interval post initial dose and reductions were maintained throughout the 24-week treatment period. Mean monthly headache episodes also decreased by 8.4 (100 mg) and 9.0 (300 mg) compared to a decrease of 7.1 with placebo. The proportion of headache episodes that were migraine attacks decreased by 11.2% (100 mg), 12.4% (300 mg), and 3.9% (placebo), and among remaining headaches decreases in severe pain, nausea, phonophobia, photophobia, and physical activity limitations were numerically greater than placebo.
Patients with chronic migraine treated with eptinezumab decreased the monthly severity and frequency of headache days and episodes more than placebo. Beyond decreased headache frequency, patients treated with eptinezumab reported a reduction in the percent of remaining headache episodes that were migraine attacks, as well as a decrease in burdensome symptoms of headache episodes, indicating additional decreased headache severity after eptinezumab treatment.Trial registration: ClinicalTrials.gov Identifier: NCT02974153; registered November 23, 2016.
研究依替唑仑治疗慢性偏头痛患者后，头痛发作的发生、严重程度和症状变化。
PROMISE-2 是一项双盲、安慰剂对照、平行组试验，将慢性偏头痛成人患者随机分为依替唑仑 100mg、300mg 或安慰剂 IV，每 12 周 1 次，最多 24 周（2 次输注）。在 28 天基线期和 24 周治疗期间，患者每天通过电子日记报告头痛发作（偏头痛和非偏头痛）及其特征。
共有 1072 例患者纳入本次事后分析。与安慰剂相比，首次剂量后第 4 周间隔内，每月头痛天数分别减少 8.9（100mg）和 9.7（300mg），降幅分别为 7.3；整个 24 周治疗期间，降幅保持不变。每月头痛发作次数也分别减少 8.4（100mg）和 9.0（300mg），而安慰剂组减少 7.1。偏头痛发作的头痛发作比例减少 11.2%（100mg）、12.4%（300mg）和 3.9%（安慰剂），其余头痛中严重疼痛、恶心、恐声、畏光和身体活动受限的减少程度大于安慰剂。
接受依替唑仑治疗的慢性偏头痛患者每月头痛天数和发作的严重程度和频率均低于安慰剂。除了头痛发作频率降低外，接受依替唑仑治疗的患者还报告偏头痛发作的剩余头痛发作比例降低，以及头痛发作的负担症状减轻，表明依替唑仑治疗后头痛严重程度进一步降低。
ClinicalTrials.gov 标识符：NCT02974153；注册于 2016 年 11 月 23 日。
