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Abstract Details

Post Hoc Analysis of PROGRESS: Evaluating the Safety of Atogepant in Participants With Chronic Migraine and Cardiovascular Risk Factors
Headache
P10 - Poster Session 10 (8:00 AM-9:00 AM)
2-012
Migraine is associated with cardiovascular disease (CVD) and CV-RFs.
Evaluate the safety of atogepant in PROGRESS trial participants with chronic migraine (CM) and cardiovascular risk factors (CV-RFs).
A 12-week, international, randomized, double-blind, placebo-controlled phase 3 trial (PROGRESS; NCT03855137) enrolled participants (18-80 years) with ≥1-year CM (≥15 monthly headache days [MHDs] for 3 months before screening; ≥15 headache days [≥8 migraine days] during the 4-week screening period). Participants treated with atogepant 30mg twice-daily, 60mg daily, or placebo were stratified by 0, 1, or ≥2 baseline CV-RFs. CV-RFs included age (men: ≥45; women: ≥55), smoking, body mass index (BMI) ≥25kg/m2, hypertension, diabetes, dyslipidemia, sleep apnea, concomitant CVD or diabetes medicines, and history of stroke, myocardial infarction, transient ischemic attack, or peripheral arterial disease. CV treatment-emergent adverse events (TEAEs) were assessed.
Of 773 participants, 518 (1 missing data) comprised the pooled atogepant group (0 CV-RFs: 110[21.2%]; 1 CV-RF: 146[28.2%]; ≥2 CV-RFs: 261[50.4%]) and 255 comprised the placebo group (0 CV-RFs: 47[18.4%]; 1 CV-RF: 92[36.1%]; ≥2 CV-RFs: 116[45.5%]). Among all participants, the majority had ≥2 CV-RFs compared to 0 or 1 CV-RFs. At baseline, participants with ≥2 CV-RFs had higher mean age, BMI, and MHDs versus those with 0 or 1 CV-RFs. Most common CV-RFs were dyslipidemia (47.6%), BMI ≥25kg/m2 (43.1%), and hypertension (40.9%). CV-TEAEs occurred at low frequencies among participants with ≥2 CV-RFs (placebo: 3/116[2.6%]; pooled atogepant: 9/261[3.4%]), and none were serious. Treatment-related CV-TEAEs included palpitations (n=2) and increased blood pressure (n=1) in the pooled atogepant group (all 30mg twice-daily) and flushing (n=1) in the placebo group. Palpitations led to 1 discontinuation (assessed as not treatment-related) in the pooled atogepant group.
This post hoc analysis demonstrates that CV-TEAEs occurred at low frequencies among atogepant-treated participants with CM and CV-RFs. All CV-TEAEs were nonserious, most were not treatment-related, and only 1 led to discontinuation.
Authors/Disclosures
Stephanie J. Nahas, MD, FAAN (Thomas Jefferson University)
PRESENTER
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 Lundbeck. Dr. Nahas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Theranica. Dr. Nahas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer. Dr. Nahas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Tonix. Dr. Nahas has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Neurology Learning Network. Dr. Nahas has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Springer. 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/talent for CME event with Medscape/WebMD.
Patricia Jeanne Markovi Best, MD (Mayo Clinic) An immediate family member of Dr. Best has stock in Sorrento Therapeutics. The institution of an immediate family member of Dr. Best has received research support from Sorrento Therapeutics. The institution of an immediate family member of Dr. Best has received research support from Bristol Myers. An immediate family member of Dr. Best has received intellectual property interests from a discovery or technology relating to health care.
Andrea Harriott, MD (Massachusetts General Hospital) Dr. Harriott has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Theranica. Dr. Harriott has received personal compensation in the range of $5,000-$9,999 for serving as an officer or member of the Board of Directors for Headache Cooperative of New England. The institution of Dr. Harriott has received research support from Electrocore. Dr. Harriott has a non-compensated relationship as a Author agreement with Abbvie that is relevant to AAN interests or activities. Dr. Harriott has a non-compensated relationship as a Researcher/Receipt of drug with Praxis that is relevant to AAN interests or activities.
Teshamae Monteith, MD, FAAN (University of Miami) Dr. Monteith has received personal compensation in the range of $0-$499 for serving as a Consultant for Abbvie. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for LinPharma. Dr. Monteith has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for HMP Global . 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 e-Neura. 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 $0-$499 for serving as a Consultant for Merz. 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 Lundbeck. 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 Alder. 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 Alder. 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 . The institution of Dr. Monteith has received research support from AbbVie. The institution of Dr. Monteith has received research support from Amgen. The institution of Dr. Monteith has received research support from Teva. The institution of Dr. Monteith has received research support from Electrocore. The institution of Dr. Monteith has received research support from Novartis . The institution of Dr. Monteith has received research support from Amgen. The institution of Dr. Monteith has received research support from lilly. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Education with Medscape. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Education with Massachusetts Medical Society . Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Education with Academic CME. Dr. Monteith has received personal compensation in the range of $10,000-$49,999 for serving as a Education with Rockpointe. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Neuodiem. 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 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.
Cristina Tassorelli Cristina Tassorelli has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Cristina Tassorelli has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Dompè. Cristina Tassorelli has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva. Cristina Tassorelli has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Cristina Tassorelli has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pfizer. The institution of Cristina Tassorelli has received research support from Abbvie.
Yingyi Liu, PhD (AbbVie) Dr. Liu has nothing to disclose.
Brett Dabruzzo, PharmD (AbbVie Medical Affairs) Dr. Dabruzzo has received personal compensation for serving as an employee of AbbVie. Dr. Dabruzzo has stock in AbbVie.
Rosa Liliana De Abreu Ferreira, MD (Abbvie) Dr. De Abreu Ferreira has received personal compensation for serving as an employee of AbbVie. Dr. De Abreu Ferreira has stock in AbbVie.
Jonathan H. Smith, MD (AbbVie) Dr. Smith has received personal compensation for serving as an employee of AbbVie. Dr. Smith has stock in AbbVie.