■这项研究比较了疗效,耐受性,rimegepant75mg口服片剂-一种小分子降钙素基因受体肽(CGRP)受体拮抗剂-与安慰剂在偏头痛的急性治疗中的安全性。
■这种双盲,随机化,安慰剂对照试验纳入年龄≥18岁且有至少1年偏头痛病史的成年人.参与者随机接受75mg口服片剂或安慰剂治疗中度或重度疼痛强度的单次偏头痛发作。共同终点,疼痛自由和免于最烦人的症状([MBS]恶心,畏光,或恐惧症)在给药后2小时,使用Mantel-Haenszel风险估计进行评估。
■在注册的1485名参与者中,1162(78.2%)被随机分配给rimegepant(n=582)或安慰剂(n=580)。大多数参与者(85.5%)是女性;该人群的平均(SD)年龄为41.6(12.2)岁,每月有4.7(1.8)偏头痛发作史。给药后2小时,与安慰剂组相比,接受rimegepant治疗的参与者的疼痛自由度较高(19.2%[104/543]vs14.2%[77/541];风险差异4.9;95%置信区间[CI]0.5~9.3;P=0.0298)和MBS自由度较高(36.6%[199/543]vs27.7%[150/541];风险差异8.9;95%CI3.4~14.4;P=0.0016.Rimegepant治疗的参与者在给药后2小时的疼痛缓解率也更高(56.0%[304/543]对45.7%[247/541];风险差异10.3;95%CI4.4至16.2,P=0.0006)。最常见的不良事件是恶心(0.9%[5/546]vs1.1%[6/549])和头晕(0.7%[4/546]vs0.4%[2/549])。没有发现药物引起的肝损伤的信号。
■Rimegepant75mg口服片剂可有效治疗偏头痛。耐受性和安全性与安慰剂相似,没有肝毒性的证据.
■Clinicaltrials.gov标识符:NCT03235479。
研究人员想知道75毫克的rimegepant对偏头痛的急性治疗是否有效和安全。他们给了一半的参与者rimegepant和一半的安慰剂,并等待了2个小时。然后,他们测量了除疼痛外头痛和最令人讨厌的偏头痛症状(恶心,对光或声音的敏感度)消失了。他们还测量了副作用,以确保rimegepant是安全的。该研究包括1084名患有偏头痛的成年人,其中927人(86%)是女性。服药两小时后:rimegepant的疼痛自由度为19%,安慰剂的疼痛自由度为14%。使用rimegepant可以摆脱最麻烦的症状的比例为37%,使用安慰剂的比例为28%。疼痛缓解率,定义为从中度或重度疼痛到轻度或无疼痛的过渡,56%的患者使用rimegepant,46%的患者使用安慰剂。最常见的副作用是恶心和头晕,影响不到1%的rimegepant患者。Rimegepant75mg比安慰剂治疗偏头痛更有效,具有相似的耐受性和安全性。
UNASSIGNED: This study compared the efficacy, tolerability, and safety of rimegepant 75 mg oral
tablet - a small molecule calcitonin-gene receptor peptide (CGRP) receptor antagonist - with placebo in the acute treatment of migraine.
UNASSIGNED: This double-blind, randomized, placebo-controlled trial enrolled adults aged ≥18 years with at least a 1-year history of migraine. Participants randomized to rimegepant 75 mg oral
tablet or placebo treated a single migraine attack of moderate or severe pain intensity. The coprimary endpoints, pain freedom and freedom from the most bothersome symptom ([MBS] nausea, photophobia, or phonophobia) at 2 hours postdose, were evaluated using Mantel-Haenszel risk estimation.
UNASSIGNED: Of the 1485 participants enrolled, 1162 (78.2%) were randomized to rimegepant (n = 582) or placebo (n = 580). Most participants (85.5%) were female; the population had a mean (SD) age of 41.6 (12.2) years and a history of 4.7 (1.8) migraine attacks per month. At 2 hours postdose, rimegepant-treated participants had higher pain freedom rates (19.2% [104/543] vs 14.2% [77/541]; risk difference 4.9; 95% confidence interval [CI] 0.5 to 9.3; P=0.0298) and MBS freedom rates (36.6% [199/543] vs 27.7% [150/541]; risk difference 8.9; 95% CI 3.4 to 14.4; P=0.0016) than placebo-treated participants. Rimegepant-treated participants also had higher rates of pain relief (56.0% [304/543] vs 45.7% [247/541]; risk difference 10.3; 95% CI 4.4 to 16.2, P=0.0006) at 2 hours postdose. The most common adverse events were nausea (0.9% [5/546] vs 1.1% [6/549]) and dizziness (0.7% [4/546] vs 0.4% [2/549]). No signal of drug-induced liver injury due to rimegepant was identified.
UNASSIGNED: Rimegepant 75 mg oral
tablet was effective in the acute treatment of migraine. Tolerability and safety were similar to placebo, with no evidence of hepatotoxicity.
UNASSIGNED: Clinicaltrials.gov Identifier: NCT03235479.
Researchers wanted to know if rimegepant 75 mg is effective and safe for the acute treatment of migraine. They gave half the participants rimegepant and half placebo and waited 2 hours. Then, they measured the percentages of participants whose headache and most bothersome migraine symptom besides pain (nausea, sensitivity to light or sound) were gone. They also measured side effects to make sure rimegepant is safe. The study included 1084 adults with migraine, 927 (86%) of whom were women. Two hours after taking the medicine: pain freedom was 19% with rimegepant and 14% with placebo. Freedom from the most bothersome symptom was 37% with rimegepant and 28% with placebo. Pain relief rates, defined as the transition from moderate or severe pain to pain that was mild or absent, occurred in 56% with rimegepant and 46% with placebo. The most common side effects were nausea and dizziness, which affected fewer than 1% of rimegepant patients. Rimegepant 75 mg was more effective than placebo for migraine, with similar tolerability and safety.