1. Monthly migraine days were significantly reduced in atogepant 30 mg twice daily and atogepant 60 mg once daily groups compared to placebo.
2. The frequency of acute medication use for headaches was reduced among patients receiving atogepant compared to placebo.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Migraine is a chronic neurological disease affecting more than 1 billion people globally. Injectable chronic migraine therapy includes calcitonin gene-related peptide (CGRP) receptor antagonists (gepants) and onabotulinumtoxinA. Atogepant is an oral therapy approved for the preventive treatment of migraine, although little is currently known. This randomized controlled trial aimed to assess the safety, efficacy, and tolerability of atogepant for the prevention of chronic migraines. The primary outcome of this study was the change in mean monthly migraine days (MMDs) from baseline to 12 weeks, while key secondary outcomes were the reduction in MMDs and use of rescue medication. According to study results, atogepant 30 mg twice daily and atogepant 60 mg once daily both showed clinically relevant reductions in MMDs over a 12-week period, compared to placebo. Although this study was well done, a major limitation was the relatively short duration which may not capture the long-term effects and tolerability of this drug.
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In-depth [randomized-controlled trial]: Between Mar 11, 2019, and Jan 20, 2022, 1489 patients were screened for eligibility across 142 clinical research sites in 16 countries. Included were patients aged ≥ 18 years with a history of chronic migraine lasting ≥ 1 year. Altogether, 778 patients (257 in atogepant 30 mg twice daily, 262 in atogepant 60 mg daily, and 259 in placebo) were included in the final analysis. The mean patient age was 42.1 years, and the majority were White (59%) females (88%). The primary outcome of reduction in mean MMDs was significantly greater in the atogepant 30 mg twice daily (-7.5, standard error [SE] 0.4; p<0.0001) and atogepant 60 mg once daily (-6.9, SE 0.4; p=0.0009) groups compared to placebo (-5.1, SE 0.4). The secondary outcome demonstrated a similar reduction pattern of 6.9 days for atogepant 60 mg once daily compared to placebo. Furthermore, patients who received atogepant 30 mg (-6.7 days, SE 0.4) and 60 mg (-6.2 days, SE 0.4) had significantly reduced rates of mean monthly acute medication use compared to placebo (-4.1 days; SE 0.4). Overall, findings from this study suggest that atogepant, at both dosages, effectively reduces MMDs in chronic migraine patients while being well-tolerated.
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