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Abstract Details

Risk of Hypertension in Erenumab-treated Patients With Migraine in Clinical Trials and in the Postmarketing Setting
Headache
Headache Posters (7:00 AM-5:00 PM)
044
Because calcitonin gene-related peptide (CGRP) can mediate vasodilation, hypertension is a theoretical risk when inhibiting CGRP signaling. In May 2020, the US Prescribing Information for erenumab, a CGRP-receptor antagonist for migraine prevention, was updated to include the risk of hypertension based on postmarketing experience.
Assess the risk of hypertension among migraine patients treated with erenumab in clinical trials and the postmarketing setting. 

Hypertension adverse events (AEs) were identified from the Amgen Clinical Trial and Global Safety Databases using the standardized MedDRA query (SMQ) for hypertension.

During the 12-week, double-blind, placebo-controlled, treatment phase across pooled phase 2/3 clinical studies (placebo [n = 1043], erenumab 70 mg [n = 893], erenumab 140 mg [n = 507]), the incidence of hypertension AEs (0.9%, 0.8%, 0.2%) and proportion of patients starting a new antihypertensive medication (1.4%, 1.0%, 0.4%) were similar across treatment groups. Exposure-adjusted patient incidence of hypertension did not increase over time during open-label erenumab treatment up to 5 years. In the postmarketing setting from May 17, 2018 to January 31, 2020 (245,682 person-years exposure), 362 hypertension AEs (355 cases; 0.144 per 100 person-years) were reported; 158 (43.6%) with a medical history of or risk factors for hypertension. Time to onset was available for 121 hypertension AEs (33.4%); 56 (46.2%) occurred within 1 week of erenumab initiation (43 [35.5%] within 1 day). Most AE reports described a single instance of blood pressure elevation (91.7%) and lacked details of antihypertensive treatment administered (88.6%).

While clinical trials did not show increased risk of hypertension in patients treated with erenumab, hypertension has been reported with erenumab in the postmarketing setting. Given limitations of postmarketing AE reports, additional data are needed to fully characterize the nature of and extent to which hypertension is a risk associated with erenumab and other CGRP-pathway antagonists.
Authors/Disclosures
David W. Dodick, MD, FAAN (Atria Institute)
PRESENTER
Dr. Dodick has received personal compensation for serving as an employee of Mayo Clinic. Dr. Dodick has received personal compensation for serving as an employee of Atria Health. Dr. Dodick has received personal compensation for serving as an employee of Thomas Jefferson University . Dr. Dodick has received personal compensation for serving as an employee of Norwegian University of Science and Technology. Dr. Dodick has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amgen. Dr. Dodick has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Allergan. Dr. Dodick has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biohaven. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biopharm Communications. Dr. Dodick has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Dodick has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eli Lilly. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Inside Practice Australia. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Clinical Education Alliance. Dr. Dodick has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Headache Cooperative of the Pacific . Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medica Communications. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MJ Healthcare. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Nocira. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Praxis. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Revance . Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Synapse Medical Communications. Dr. Dodick has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Vector Psychometrics. Dr. Dodick has received personal compensation in the range of $0-$499 for serving as a Consultant for Ayya Biosciences. Dr. Dodick has received personal compensation in the range of $0-$499 for serving as a Consultant for Theranica. Dr. Dodick has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Atria. Dr. Dodick has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for WebMD. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Thomas Jefferson University. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medforce. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Precision HEOR. Dr. Dodick has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Canadian Headache Society. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Headache Cooperative of New England. Dr. Dodick has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amgen Japan. Dr. Dodick has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for KingDevick Technologies. Dr. Dodick has received personal compensation in the range of $1,000,000+ for serving as an officer or member of the Board of Directors for Precon Health. Dr. Dodick has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Ontologics. Dr. Dodick has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Matterhorn. Dr. Dodick has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Axon Therapeutics. Dr. Dodick has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Cephalgia Group. Dr. Dodick has stock in Healint. Dr. Dodick has stock in Theranica. Dr. Dodick has stock in Aural Analytics . Dr. Dodick has stock in Epien. Dr. Dodick has stock in Matterhorn. Dr. Dodick has stock in Ontologics. Dr. Dodick has stock in Precon Health. Dr. Dodick has stock in King Devick Technologies. Dr. Dodick has stock in Nocira. Dr. Dodick has stock in Exsano. Dr. Dodick has stock in Palion. Dr. Dodick has stock in AYYA Biosciences. Dr. Dodick has stock in Perfood. Dr. Dodick has stock in Cephalgia Group. Dr. Dodick has stock in Atria Health. Dr. Dodick has stock in Man and Science. Dr. Dodick has stock in Eigenlyfe. An immediate family member of Dr. Dodick has stock in ScotiaLyfe. Dr. Dodick has stock in Axon Therapeutics. The institution of Dr. Dodick has received research support from Department of Defense. The institution of Dr. Dodick has received research support from Patient Centered Outcomes Research Institute. The institution of Dr. Dodick has received research support from Henry Jackson Foundation. Dr. Dodick has received intellectual property interests from a discovery or technology relating to health care. Dr. Dodick has received intellectual property interests from a discovery or technology relating to health care. Dr. Dodick has received intellectual property interests from a discovery or technology relating to health care. Dr. Dodick has received publishing royalties from a publication relating to health care. Dr. Dodick has received publishing royalties from a publication relating to health care. Dr. Dodick has received publishing royalties from a publication relating to health care. Dr. Dodick has a non-compensated relationship as a Chair with American Brain Foundation that is relevant to AAN interests or activities. Dr. Dodick has a non-compensated relationship as a Committee member/Course Director with American Academy of Neurology that is relevant to AAN interests or activities. Dr. Dodick has a non-compensated relationship as a Chair/Immediate Past Chair with American Migraine Foundation that is relevant to AAN interests or activities. Dr. Dodick has a non-compensated relationship as a Chair Global Patient Advocacy Coalition with International Headache Society that is relevant to AAN interests or activities.
Jessica Ailani, MD, FAAN (Medstar Georgetown Neurology) Dr. Ailani has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Allergan/Abbvie. Dr. Ailani has received personal compensation in the range of $0-$499 for serving as a Consultant for Amgen. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eli Lilly. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GlaxoSmithKline. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Ailani has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Gore. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ipsen. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merz. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Theranica. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurolief. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Scilex. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Dr. Reddy. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Linpharma. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eneura. Dr. Ailani has received personal compensation in the range of $50,000-$99,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan/Abbvie. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aeon. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli Lilly. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Linpharma. Dr. Ailani has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aeon. Dr. Ailani has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Current Pain and Headache Report. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Medscape. The institution of Dr. Ailani has received research support from Satsuma. The institution of Dr. Ailani has received research support from Ipsen. The institution of Dr. Ailani has received research support from Parema. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Medical Advisor with SELF.
Stewart J. Tepper, MD (The New England Institute for Neurology and Headache) Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aeon. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amgen. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aruene. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Atheneum. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Axsome Therapeutics. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Becker Pharmaceutical Consulting. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cleaview Healhcare Partners. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CoolTech. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CRG. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Decision Resources. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Defined Health. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for DRG. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eli Lilly. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ExpertConnect. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for FCB Health. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Fenix. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GLG. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Guidepoint Global. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Health Advances. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Health Science Communications. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for HMP Communications. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Impel. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for InteractiveForums. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Keyquest. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Krog and Partners. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for M3 Global Research. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Magnolia Innovation. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MJH Holdings. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurolief. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for P Value Communications. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pain Insights Inc. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Palion Medical. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pulmatrix. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Putnam Associates. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for SAI MedPartners. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Slingshot Insights. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Spherix Global Insights. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Strategy Inc. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for System Medical Comm. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Taylor and Francis. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Theranica. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Trinity Partners. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UnityHA. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for XOC. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Click Therapeutics. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Miravo. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurofront Therapeutics. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Rehaler. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Synapse Medical Communications. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alphasights. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Perfood. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for M3 Global Research. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Scilex. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Synapse Medical Communication. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Tegus. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aeon. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ClickTherapeutics. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for CoolTech. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli Lilly. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Miravo Healthcare. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pulmatrix. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Satsuma. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for AbbVie. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Lundbeck. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Pfizer. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Scilex. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Teva. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving as a CME Speaker with Diamond Headache Clinic. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CME Speaker with Medical Learning Institute Peerview. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CME Speaker with Medical Education Speakers Network. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving as a CME Speaker with Miller Medical Communications. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CME Speaker with Physicians' Education Resource. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving as a CME Speaker with WebMD/Medscape. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CME speaker with American Headache Society. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CME speaker with Vindico Medical Education. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CME speaker with HMP Global. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CMe speaker with Medical Learning Institute Peerview.
Nico Pannacciulli (Amgen) Nico Pannacciulli has received personal compensation for serving as an employee of Amgen. Nico Pannacciulli has received stock or an ownership interest from Amgen.
Marco Navetta (Amgen) Marco Navetta has received personal compensation for serving as an employee of Amgen.
Fei Xue Fei Xue has received personal compensation for serving as an employee of Amgen Inc.
Feng *Use 393271 Zhang Feng Zhang has received personal compensation for serving as an employee of Amgen Inc.
Jessica Choudhry (Amgen) Jessica Choudhry has received personal compensation for serving as an employee of Amgen. Jessica Choudhry has received stock or an ownership interest from Amgen.