好色先生

好色先生

Explore the latest content from across our publications
Join The AAN

Log In

Forgot Password?
Create New Account

Loading... please wait

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
Evaluate the safety of atogepant in PROGRESS trial participants with chronic migraine (CM) and cardiovascular risk factors (CV-RFs).
Migraine is associated with cardiovascular disease (CVD) and 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 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.
No disclosure on file
Andrea Harriott, MD (Massachusetts General Hospital) Dr. Harriott has received personal compensation in the range of $10,000-$49,999 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 $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.
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 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. 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 Ipsen. Cristina Tassorelli has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Organon. Cristina Tassorelli has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Abbvie. Cristina Tassorelli has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Lundbeck. Cristina Tassorelli has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Organon. Cristina Tassorelli has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva . The institution of Cristina Tassorelli has received research support from Abbvie.
Yingyi Liu (AbbVie) Yingyi Liu has received personal compensation for serving as an employee of AbbVie.
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 De Abreu Ferreira Rosa De Abreu Ferreira has nothing to disclose.
Jonathan H. Smith, MD (AbbVie) Dr. Smith has received personal compensation for serving as an employee of AbbVie. Dr. Smith has stock in AbbVie.