PMID- 34591982 OWN - NLM STAT- MEDLINE DCOM- 20220214 LR - 20220721 IS - 1526-4610 (Electronic) IS - 0017-8748 (Print) IS - 0017-8748 (Linking) VI - 61 IP - 9 DP - 2021 Oct TI - Risk of hypertension in erenumab-treated patients with migraine: Analyses of clinical trial and postmarketing data. PG - 1411-1420 LID - 10.1111/head.14208 [doi] AB - OBJECTIVE: To assess the risk of hypertension in patients with migraine who received erenumab in clinical trials and in the postmarketing setting. BACKGROUND: Erenumab is a monoclonal antibody for migraine prevention that targets the calcitonin gene-related peptide (CGRP) receptor. Hypertension is a theoretical risk for inhibitors of the CGRP pathway. Although no evidence of an association between erenumab treatment and hypertension was observed during the clinical development program, adverse events (AEs) of hypertension have been identified in the postmarketing setting. METHODS: Safety data from four phase 2 and phase 3 clinical trials were used to perform a pooled analysis of hypertension AEs in patients with migraine receiving erenumab. Postmarketing AEs of hypertension were identified from the Amgen Global Safety database from May 17, 2018, through January 31, 2020. RESULTS: In the pooled analysis of clinical trials, hypertension AEs (placebo, 9/1043 [0.9%]; erenumab 70 mg, 7/893 [0.8%]; erenumab 140 mg, 1/507 [0.2%]) and percentage of patients initiating medication to treat hypertension (12/1043 [1.2%], 7/893 [0.8%], 1/507 [0.2%], respectively) were similar across treatment groups. A total of 362 AEs of hypertension were identified from the postmarketing setting, 26.2% (95/362) of which were serious, >245,000 patient-years of exposure. The exposure-adjusted incidence of hypertension was 0.144 per 100 patient-years. CONCLUSIONS: Clinical trials did not demonstrate an increased risk of hypertension with erenumab compared with placebo, and AE rates of hypertension reported with erenumab in the postmarketing setting were generally low. Additional data are needed to fully characterize the extent to which hypertension is a risk associated with erenumab. CI - (c) 2021 The Authors. Headache: The Journal of Head and Face Pain published by Wiley Periodicals LLC on behalf of American Headache Society. FAU - Dodick, David W AU - Dodick DW AUID- ORCID: 0000-0002-9486-6790 AD - Department of Neurology, Mayo Clinic, Scottsdale, Arizona, USA. FAU - Tepper, Stewart J AU - Tepper SJ AD - Department of Neurology, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire, USA. FAU - Ailani, Jessica AU - Ailani J AD - Georgetown Headache Center, Medstar Georgetown University, Washington, DC, USA. FAU - Pannacciulli, Nicola AU - Pannacciulli N AD - Global Medical Amgen Inc., Thousand Oaks, California, USA. FAU - Navetta, Marco S AU - Navetta MS AD - Global Medical Amgen Inc., Thousand Oaks, California, USA. FAU - Loop, Brett AU - Loop B AD - Global Patient Safety, Amgen Inc., Cambridge, Massachusetts, USA. FAU - Zhang, Feng AU - Zhang F AD - Global Medical Amgen Inc., Thousand Oaks, California, USA. FAU - Khodavirdi, Ani C AU - Khodavirdi AC AD - Global Medical Amgen Inc., Thousand Oaks, California, USA. FAU - Mann, Allison AU - Mann A AD - Medical Safety, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA. FAU - Abdrabboh, Ahmad AU - Abdrabboh A AD - Medical Safety, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA. FAU - Kalim, Jawed AU - Kalim J AD - Medical Safety, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA. LA - eng PT - Journal Article DEP - 20210930 PL - United States TA - Headache JT - Headache JID - 2985091R RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Calcitonin Gene-Related Peptide Receptor Antagonists) RN - I5I8VB78VT (erenumab) SB - IM MH - Adult MH - Antibodies, Monoclonal, Humanized/administration & dosage/*adverse effects MH - Calcitonin Gene-Related Peptide Receptor Antagonists/administration & dosage/*adverse effects MH - Clinical Trials, Phase II as Topic/*statistics & numerical data MH - Clinical Trials, Phase III as Topic/*statistics & numerical data MH - *Drug-Related Side Effects and Adverse Reactions MH - Female MH - Humans MH - Hypertension/*chemically induced MH - Male MH - Middle Aged MH - Migraine Disorders/*drug therapy MH - Product Surveillance, Postmarketing/*statistics & numerical data PMC - PMC9293040 OTO - NOTNLM OT - blood pressure OT - calcitonin gene-related peptide OT - drug safety OT - hypertension OT - individual case safety report OT - postmarketing surveillance COIS- David W. Dodick reports the following conflicts within the past 12 months: Consulting: AEON, Amgen, Clexio, Cerecin, Cooltech, Ctrl M, Allergan, Alder, Biohaven, GSK, Linpharma, Lundbeck, Promius, Eli Lilly, eNeura, Novartis, Impel, Satsuma, Theranica, WL Gore, Nocira, XoC, Zosano, Upjohn (Division of Pfizer), Pieris, Praxis, Revance, Equinox. Honoraria: Clinical Care Solutions, CME Outfitters, Curry Rockefeller Group, DeepBench, Global Access Meetings, KLJ Associates, Academy for Continued Healthcare Learning, Majallin LLC, Medlogix Communications, MJH Lifesciences, Miller Medical Communications, Southern Headache Society (MAHEC), WebMD Health/Medscape, Wolters Kluwer, Oxford University Press, Cambridge University Press. Research Support: Department of Defense, National Institutes of Health, Henry Jackson Foundation, Sperling Foundation, American Migraine Foundation, Patient Centered Outcomes Research Institute (PCORI). Stock Options/Shareholder/Patents/Board of Directors: Ctrl M (options), Aural analytics (Options), ExSano (Options), Palion (Options), Healint (Options), Theranica (Options), Second Opinion/Mobile Health (Options), Epien (Options/Board), Nocira (Options), Matterhorn (Shares/Board), Ontologics (Shares/Board), King-Devick Technologies (Options/Board), Precon Health (Options/Board). Patent 17189376.1-1466:vTitle: Botulinum Toxin Dosage Regimen for Chronic Migraine Prophylaxis. Stewart Tepper reports consulting for Aeon, Alexsa, Allergan/Abbvie, Alphasights, Amgen, Aperture Venture Partners, Aralez Pharmaceuticals Canada, Axsome Therapeutics, Becker Pharmaceutical Consulting, BioDelivery Sciences International, Biohaven, ClearView Healthcare Partners, CoolTech, CRG, Currax, Decision Resources, DeepBench, DRG, Eli Lilly and Company, Equinox, ExpertConnect, GLG, Guidepoint Global, Impel, InteractiveForums, M3 Global Research, Magellan Rx Management, Medicxi, Navigant Consulting, Neurolief, Nordic BioTech, Novartis, Palion Medical, Pulmatrix, Reckner Healthcare, Relevale, Satsuma, Slingshot Insights, Spherix Global Insights, Teva, Theranica, Thought Leader Select, Trinity Partners, Unity HA, XOC, and Zosano; speaking and CME teaching for American Academy of Neurology, American Headache Society, Catamount Medical Education, Cleveland Clinic Foundation, Diamond Headache Clinic, Elsevier, Forefront Collaborative, Hamilton General Hospital (Ontario, Canada), Headache Cooperative of New England, Henry Ford Hospital (Detroit), Inova, Medical Learning Institute Peerview, Medical Education Speakers Network, Miller Medical Communications, North American Center for CME, Physicians' Education Resource, PlatformQ Education, Rockpointe, ScientaCME, and WebMD/Medscape; employment with American Headache Society, Thomas Jefferson University, and Dartmouth-Hitchcock Medical Center; and other activities with Headache, Headache Currents, and Wiley Blackwell. He has received research grants exclusively paid to Dartmouth-Hitchcock Medical Center without personal compensation from Allergan, Amgen, ElectroCore, Eli Lilly, Lundbeck, Neurolief, Novartis, Satsuma, and Zosano. Jessica Ailani has received consulting fees from Allergan/Abbvie, Axsome, Amgen, Aeon, Biohaven, Lundbeck, GlaxoSmithKline, Eli Lilly, Impel, Satsuma, Theranica, Nesos, Teva, Medscape, and NeurologyLive; stock options from CtrlM, honoraria for participation on speakers bureau from Allergan/Abbvie, Amgen, Lundbeck, Eli Lilly, and Teva; her institution has received grant support for clinical trials from Allergan/Abbvie, American Migraine Foundation, Eli Lilly, Satsuma, and Zosano, and she serves as section editor for Current Pain and Headache Reports, medical editor for SELF, and an editor for NeurologyLive. Nicola Pannacciulli, Marco Navetta, Brett Loop, Feng Zhang, and Ani C. Khodavirdi are employees and own stock in Amgen. Allison Mann, Ahmad Abdrabboh, and Jawed Kalim are employees of Novartis. EDAT- 2021/10/01 06:00 MHDA- 2022/02/15 06:00 PMCR- 2022/07/18 CRDT- 2021/09/30 17:32 PHST- 2021/06/29 00:00 [revised] PHST- 2021/04/03 00:00 [received] PHST- 2021/07/19 00:00 [accepted] PHST- 2021/10/01 06:00 [pubmed] PHST- 2022/02/15 06:00 [medline] PHST- 2021/09/30 17:32 [entrez] PHST- 2022/07/18 00:00 [pmc-release] AID - HEAD14208 [pii] AID - 10.1111/head.14208 [doi] PST - ppublish SO - Headache. 2021 Oct;61(9):1411-1420. doi: 10.1111/head.14208. Epub 2021 Sep 30.