The oral calcitonin gene-related peptide (CGRP) receptor antagonist atogepant is effective in preventing rebound headache related to medication overuse in patients with chronic migraine (CM), new research suggested.
Results of a subgroup analysis of a phase 3, 12-week randomized, double-blind, placebo-controlled trial showed up to a 62% reduction in the proportion of atogepant-treated participants who met acute medication overuse criteria.
“Based on our findings, treatment with atogepant may potentially decrease the risk of developing rebound headache by reducing the use of pain medications,” principal investigator Peter Goadsby, MD, PhD, of King’s College London, London, England, said in a news release.
The study was published online on June 26 in Neurology.
Effective Prevention Needed
Acute treatments for migraine can mitigate symptoms and reduce disability but can also be ineffective and even result in increased dosing and overuse of these medications, the investigators noted.
Acute medication overuse is defined as “taking simple analgesics for ≥ 15 days per month or taking triptans, ergots, opioids, or combinations or medications for ≥ 10 days per month.”
“There is a high prevalence of pain medication overuse among people with migraine as they try to manage what are often debilitating symptoms,” Goadsby said. “However, medication overuse can lead to more headaches, called rebound headaches, so more effective preventive treatments are needed.”
Atogepant was developed for migraine prevention in adults. It had been studied in the phase 3 PROGRESS trial, which showed it significantly reduced monthly migraine days (MMDs) compared with placebo during the 12-week trial.
The new subgroup analysis of the study focused specifically on the efficacy and safety of atogepant vs placebo in participants with CM with, and without, medication overuse.
Participants (mean age, 42.1 years; 87.6% women) were randomized to receive either atogepant 30 mg twice daily (n=253), atogepant 60 mg once daily (n=256), or placebo (n=240), with baseline demographics and clinical characteristics similar across all treatment arms. A total of 66.2% met baseline acute medication overuse criteria.
Participants were asked to record migraine and headache experiences in an electronic diary.
‘Effective and Safe’
Participants in both atogepant groups experienced fewer monthly headache days (MHDs) than those in the placebo group, with a least squares mean difference (LSMD) of −2.7 (95% CI, −4.0 to −1.4) in the atogepant 30 mg twice daily group and −1.9 (95% CI, −3.2 to −0.6) in the atogepant 60 mg once daily group.
MHDs were also reduced in both treatment groups, with LSMDs of −2.8 (95% CI, −4.0 to −1.5) and −2.1 (95% CI, −3.3 to −0.8), respectively. Mean acute medication use days were lower in both the treatment groups, with LSMDs of −2.8 (95% CI, −4.1 to −1.6) and −2.6 (95% CI, −3.9 to −1.3), respectively.
A higher proportion of participants achieved a ≥ 50% reduction in MMDs with atogepant 30 mg twice daily (odds ratio [OR], 2.5; 95% CI, 1.5-4.0) and atogepant 60 mg once daily (OR, 2.3; 95% CI, 1.4-3.7).
Notably, the researchers found a 52.1%-61.9% reduction in the proportion of atogepant-treated participants meeting acute medication overuse criteria during the study period vs 38.3% in the placebo group.
Similar results were observed in the subgroup without acute medication overuse.
Treatment-emergent adverse events were reported by 55.8% of participants treated with atogepant 30 mg twice daily, 66.1% with atogepant 60 mg once daily, and 48.5% with placebo in the acute medication overuse subgroup, with similar reports in the non-overuse subgroup.
A limitation cited by the authors was that participants’ self-report of migraines and headaches via electronic diaries might have been inaccurate.
Nevertheless, they concluded that the results showed atogepant to be an “effective and safe” preventive treatment for patients with CM with, and without, acute medication overuse.
AbbVie funded this study and participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the publication. No honoraria or payments were made for authorship. Goadsby received personal fees from AbbVie during the conduct of the study, and over the last 36 months, he received a research grant from Celgene; personal fees from Aeon Biopharma, Amgen, CoolTechLLC, Dr. Reddy’s, Eli Lilly and Company, Epalex, Lundbeck, Novartis, Pfizer, Praxis, Sanofi, Satsuma, ShiraTronics, Teva Pharmaceuticals, and Tremeau; personal fees for advice through Gerson Lehrman Group, Guidepoint, SAI Med Partners, and Vector Metric; fees for educational materials from CME Outfitters; and publishing royalties or fees from Massachusetts Medical Society, Oxford University Press, UpToDate, and Wolters Kluwer. The other authors’ disclosures are listed on the original paper.
Batya Swift Yasgur, MA, LSW, is a freelance writer with a counseling practice in Teaneck, New Jersey. She is a regular contributor to numerous medical publications, including Medscape and WebMD, and is the author of several consumer-oriented health books as well as Behind the Burqa: Our Lives in Afghanistan and How We Escaped to Freedom (the memoir of two brave Afghan sisters who told her their story).
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