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Abstract Details

Post-hoc Analysis of Safety in Phase 3 Atogepant ADVANCE Trial Participants with or without Cardiovascular Disease Risk Factors
Headache
P2 - Poster Session 2 (11:45 AM-12:45 PM)
15-005
To evaluate the safety of atogepant in participants with cardiovascular risk factors (CV-RFs) from the ADVANCE phase 3 trial.
Calcitonin gene-related peptide (CGRP) is a potent vasodilator of the cardiovascular system. Atogepant is an oral small molecule CGRP receptor antagonist recently approved by FDA for the preventive treatment of episodic migraine.
For this post-hoc analysis, ADVANCE (NCT03777059) trial participants were divided into a pooled atogepant (10, 30, and 60 mg once daily) treatment arm and a placebo arm. Participants were then stratified into one of three CV-RF groups (0, 1, or ≥2 CV-RFs), based on having (or history of) the following CV-RFs: age (male ≥45 years; female ≥55 years), BMI ≥25, cardiovascular disease (CVD; including but not limited to a medical history of stroke, transient ischemic attack, or myocardial infarction), diabetes, dyslipidemia, hypertension, sleep apnea, smoking; or taking concomitant medications for CVD, diabetes, or hypertension. Only safety data are reported.
Of the 680 pooled atogepant-treated participants, 11.5% had 0, 29.7% had 1, and 58.8% had ≥2 CV-RFs. Of the 222 placebo-treated participants 10.4% had 0, 34.7% had 1, and 55.0% had ≥2 CV-RFs. In total, 6 (0.7%) participants had a medical history of CVD. Cardiovascular treatment-emergent adverse events (CV-TEAEs) occurred at similar rates in pooled atogepant- (13, 1.9%) and placebo- (7, 3.2%) treated participants. The CV-TEAE of hypertension was observed in 4 (0.6%) atogepant-treated participants and in 0 placebo-treated participants. CV-TEAE and overall treatment-emergent serious adverse events were similar between atogepant- and placebo-treated participants with CV-RFs.
In the ADVANCE phase 3 trial, CV-TEAEs were numerically comparable among the pooled atogepant and placebo treated groups in the presence of CV risk factors; therefore providing clinical insight into the safety profile of atogepant when used in those with CV risk factors.
Authors/Disclosures
Brett Dabruzzo, PharmD (AbbVie Medical Affairs)
PRESENTER 		Dr. Dabruzzo has received personal compensation for serving as an employee of AbbVie. Dr. Dabruzzo has stock in AbbVie.
Andrew M. Blumenfeld, MD, FAAN (Cedars Sinai) Dr. Blumenfeld has received personal compensation for serving as an employee of The Los Angeles Headache Center. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Allergan/Abbvie. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Best Doctors. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Guidepoint. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for GLG. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Theranica. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Aeon. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Revance. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lilly. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Lundbeck. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Axsome. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Axon. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Cedar Sinai. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan/Abbvie. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aeon. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Revance. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Theranica. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Axsome. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Allergan/Abbvie. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Teva. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Lilly. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Lundbeck. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for AXSOME.
Susan Hutchinson Susan Hutchinson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alder Pharmaceutical. Susan Hutchinson has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Allergan Pharmaceutical . Susan Hutchinson has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amgen Pharmaceutical. Susan Hutchinson has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biohaven . Susan Hutchinson has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Currax Pharmaceutical . Susan Hutchinson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for electroCore. Susan Hutchinson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lilly Pharmaceutical . Susan Hutchinson has received personal compensation in the range of $0-$499 for serving as a Consultant for Lundbeck Pharmaceutical. Susan Hutchinson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Susan Hutchinson has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Teva. Susan Hutchinson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Theranica. Susan Hutchinson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Upsher Smith. Susan Hutchinson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Impel Pharmaceutical . Susan Hutchinson has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan . Susan Hutchinson has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly Pharmaceutical . Susan Hutchinson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Allergan/AbbVie. Susan Hutchinson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen. Susan Hutchinson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven . Susan Hutchinson has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Lilly Pharmaceutical . Susan Hutchinson has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Lundbeck . Susan Hutchinson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva . Susan Hutchinson has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for Headache Cooperative of the Pacific . Susan Hutchinson has received publishing royalties from a publication relating to health care.
Jelena M. Pavlovic, MD, PhD (Albert Einstein College of Medicine) Dr. Pavlovic has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven.
No disclosure on file
Teshamae Monteith, MD, FAAN (University of Miami) Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for American Headache Society . Dr. Monteith has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Monteith has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merz. Dr. Monteith has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva . Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for AAN . Dr. Monteith has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for AAN. Dr. Monteith has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for AAN . Dr. Monteith has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Cephalalgia. Dr. Monteith has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for New England Journal of Medicine JW. The institution of Dr. Monteith has received research support from AbbVie. The institution of Dr. Monteith has received research support from lilly. The institution of Dr. Monteith has received research support from Ipsen. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a 好色先生 with Medscape. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a 好色先生 with Massachusetts Medical Society . Dr. Monteith has a non-compensated relationship as a President Elect with Florida Society of Neurology that is relevant to AAN interests or activities. Dr. Monteith has a non-compensated relationship as a Editorial Board /Board Member with American Migraine Foundation that is relevant to AAN interests or activities. Dr. Monteith has a non-compensated relationship as a Board Member with International Headache Society that is relevant to AAN interests or activities. Dr. Monteith has a non-compensated relationship as a author with Pfizer that is relevant to AAN interests or activities. Dr. Monteith has a non-compensated relationship as a author with Abbvie that is relevant to AAN interests or activities. Dr. Monteith has a non-compensated relationship as a author with Theranica that is relevant to AAN interests or activities.
No disclosure on file
Jonathan H. Smith, MD (AbbVie) Dr. Smith has received personal compensation for serving as an employee of AbbVie. Dr. Smith has stock in AbbVie.
No disclosure on file
Stephanie J. Nahas, MD, FAAN (Thomas Jefferson University) Dr. Nahas has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for AbbVie. Dr. Nahas has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eli Lilly. Dr. Nahas has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Nahas has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome. Dr. Nahas has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amneal. Dr. Nahas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bausch Health. Dr. Nahas has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Ipsen. Dr. Nahas has received publishing royalties from a publication relating to health care. Dr. Nahas has received publishing royalties from a publication relating to health care. Dr. Nahas has received personal compensation in the range of $500-$4,999 for serving as a expert for CME activities with Medscape/WebMD. Dr. Nahas has a non-compensated relationship as a Board Member-at-Large with American Headache Society that is relevant to AAN interests or activities. Dr. Nahas has a non-compensated relationship as a Executive Board Member with The Headache Alliance that is relevant to AAN interests or activities.