Lancet Neurology: The safety, toeration and effectiveness of oral Atogepant treatment for thyset migraines in adults: a double-blind, randomized phase 2b/3 trial.

Atogepant is an oral small molecule calcitonin gene-associated peptide (CGRP) peptide antagonist, and a series of studies have been published on Atogepant's treatment of migraines.
the authors aim to examine the safety, tolerance and efficacy of atogepant oral doses.
method: In this double-blind 2b/ 3 trial, adults with a migraine history of 4-14 days per month (aged 18-75 years) were assigned a ratio of 2:1:2:2:1:1.
took a placebo, Atogepant 10 mg per day, Atogepant 30 mg per day, Atogepant 60 mg per day, Andogepant 30 mg per day, twice a day, or 60 mg, twice a day.
participants, field personnel and all study sponsors are not clear.
study was conducted in 78 academic and private institutions in the United States.
between September 6, 2016 and April 23, 2018, 1,772 individuals were screened, 825 of whom received one dose or more of the study drug.
186 patients took a placebo, 93 patients took Atogepant 10 mg once a day, 183 patients took Atogepant 30 mg once a day, 186 patients took Atogepant 60 mg once a day, 86 patients took Atogepant 30 mg twice a day, and 91 patients took Atogepant 60 mg twice a day.
, 714 (87 per cent) of the 825 participants were women and 628 (76 per cent) were white.
migraine duration was 17.5 years (IQR 10.0-28.0), while 232 (28%) had previously used treatment.
the main analysis of 795 patients: 178 patients taking a placebo, 92 cases taking atopant 10 mg once a day, 182 taking atolpant 30 mg once a day, 177 taking Atogepant 60 mg once a day, 79 taking Atogepant 30 mg twice a day, and 87 taking Atogepant 60 mg twice a day.
results: All five Atogepant groups showed significant least square-square (SE) changes relative to the baseline on average every day of migraines over a 12-week treatment period compared to placebo: Atogepant 10 mg once a day -4.0 (0.3); p s 0.024), the group of 30 mg once a day is -3.8 (0.2; p is 0.039) and the group of 60 mg once a day is -3.6 (0.2; p s 0.039), 30 mg twice a day -4.2 (0.4; p s 0.0034), twice a day 60 mg -4.1 (0.3; p s 0.0031); placebo -2.9 (0.2).
the most common treatment of emergency adverse events (TEAE) in all groups were nausea (5% of group adverse reactions of 10 mg per day, 12% of adverse reactions of 60 mg per day) and Fatigue (one 10 mg adverse reaction rate per day (1/93) and twice-daily 60 mg adverse reaction rate of 10% (9/91) and a placebo adverse reaction rate of 3% (6/186) ).
reported a total of eight severe TAAEs (two participants in the placebo group, 30 mg once a day, 60 mg once a day, and one participant in the 10 mg group once a day).
33 (5%) of the 639 Atogepant participants reported TEAE leading to termination of treatment, and 5 (3%) of the 186 participants randomly assigned to placebo reported TEAE.
all severe TEAEs are not related to treatment.
Safety, tolerability, and efficacy of orally agency atogepant for the prevention of episodic migraine in adults: a double-blind, randomized phase 2b/3 trial Goadsby, Peter J et al. The Lancet Neurology, Volume 19, Issue 9, 727 - 737 MedSci Original Source: MedSci Original Copyright Notice: All text, images and audio and video materials on this website that indicate "Source: Met Medical" or "Source: MedSci Original" are owned by Mets Medical and are not authorized to reproduce, and any media, website or individual must indicate "Source: Mays Medicine" when transferring.
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