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Child Psychiatrist /Adult Psychiatrist

Atogepant for Episodic Migraine Leads to Less Mean Monthly Migraine Days

Keypoint: A daily 60-mg dose of atogepant significantly reduced mean monthly migraine days in patients with episodic migraine.


Atogepant for Episodic Migraine Leads

A daily 60-mg dose of atogepant taken over the course of 12 weeks reduced mean monthly migraine days in adult patients with episodic migraine who failed 2-4 classes conventional treatments, according to study results published in The Lancet Neurology.


Researchers conducted a randomized, double-blind, placebo-controlled, phase 3b trial (ELEVATE; ClinicalTrials.gov identifier: NCT04740827) to evaluate the safety, tolerability, and efficacy of daily atogepant in adult patients with episodic migraine who did not respond to 2-4 classes of conventional oral preventative treatments.


The primary outcome of interest was change from baseline in mean monthly migraine days across the 12-week treatment period. Secondary outcomes included change from baseline in mean monthly headache days and medication use across the same treatment period. Both the primary and secondary endpoints were analyzed using a mixed model for repeated measures.


Adult patients were eligible for the study if they had a history of migraine for at least 1 year and migraine onset prior to age 50. Patients included in the study also had 4-14 monthly migraine days and documented failures by 2-4 classes of oral migraine preventative treatments, 1 of which was propranolol or metoprolol, topiramate, flunarizine, or amitriptyline.


Between March 2021 and August 2022, patients (N=315; 89% women; 96% White) were randomly assigned 1:1 to receive either 60 mg of oral atogepant (n=157) or placebo (n=158) daily during the treatment period. Of these 315 patients, 313 received treatment (atogepant, 156 vs placebo, 157) and were included in the safety population. The most common previous preventative treatment failures were topiramate (55%) and amitriptyline (53%). Most patients had been failed by 2 classes of treatment (56%), followed by those who had been failed by 3 (35%), and finally those who had been failed by 4 (9%).


Compared with placebo, atogepant significantly reduced the mean monthly migraine days across the treatment period. The least squares mean changes from baseline in mean monthly migraine days across the treatment period was -1.9 (standard error [SE], 0.4) with placebo vs -4.2 (SE, 0.4) with atogepant. The least squares mean difference from placebo was -2.4 days with atogepant (95% CI, -3.2 to -1.5; adjusted P <.0001).


Atogepant also demonstrated more significant improvements for all secondary efficacy endpoints. In the atogepant group, 78 (51%) patients had a reduction of at least 50% in mean monthly migraine days over the treatment period vs 28 (18%) patients in the placebo group (odds ratio [OR], 4.8; 95% CI, 2.9-8.1; adjusted P <.0001).


The least squares mean difference for change from baseline in mean monthly headache days was -2.2 (95% CI, -3.1 to -1.3; adjusted P <.0001), indicating the superior performance of atogepant. Similarly, the least squares mean difference for change from baseline in mean monthly acute medication use days was-2.6 (95% CI, -3.4 to -1.9; adjusted P <.0001), again favoring atogepant.


Treatment-emergent adverse events (TEAEs) were reported by 81 (52%) patients in the atogepant group vs 84 (54%) patients in the placebo group. Constipation, COVID-19, nausea, and nasopharyngitis were the most commonly reported TEAEs across both the placebo and atogepant groups (3% vs 10%; 10% vs 8%; 3% vs 7%; 8% vs 5%, respectively). Most TEAEs were mildly or moderately severe.


Study limitations included a relatively brief treatment period, as well as the exclusion of patients who had been failed by more than 4 treatment classes and those with chronic migraine.


“Future studies should consider examining the efficacy, tolerability, and safety of atogepant in patients with chronic migraine and for whom two to four previous preventive treatment classes have failed,” the researchers concluded.


Disclosure: Multiple study authors declared affiliations with biotech, pharmaceutical, and or/device companies. Please see the original reference for a full list of disclosures.


This article originally appeared on Neurology Advisor

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