{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T22:55:55Z","timestamp":1791327355884,"version":"4.3.1"},"reference-count":33,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2021,9,30]],"date-time":"2021-09-30T00:00:00Z","timestamp":1632960000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["headachejournal.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Headache"],"published-print":{"date-parts":[[2021,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To assess the risk of hypertension in patients with migraine who received erenumab in clinical trials and in the postmarketing setting.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Erenumab is a monoclonal antibody for migraine prevention that targets the calcitonin gene\u2010related 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Safety data from four phase 2 and phase 3\u00a0clinical 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In the pooled analysis of clinical trials, hypertension AEs (placebo, 9\/1043 [0.9%]; erenumab 70\u00a0mg, 7\/893 [0.8%]; erenumab 140\u00a0mg, 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, &gt;245,000 patient\u2010years of exposure. The exposure\u2010adjusted incidence of hypertension was 0.144 per 100 patient\u2010years.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/head.14208","type":"journal-article","created":{"date-parts":[[2021,9,30]],"date-time":"2021-09-30T16:27:29Z","timestamp":1633019249000},"page":"1411-1420","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":55,"title":["Risk of hypertension in erenumab\u2010treated patients with migraine: Analyses of clinical trial and postmarketing data"],"prefix":"10.1111","volume":"61","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9486-6790","authenticated-orcid":false,"given":"David W.","family":"Dodick","sequence":"first","affiliation":[{"name":"Department of Neurology Mayo Clinic Scottsdale Arizona USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stewart J.","family":"Tepper","sequence":"additional","affiliation":[{"name":"Department of Neurology Geisel School of Medicine at Dartmouth Hanover New Hampshire USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica","family":"Ailani","sequence":"additional","affiliation":[{"name":"Georgetown Headache Center Medstar Georgetown University Washington DC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicola","family":"Pannacciulli","sequence":"additional","affiliation":[{"name":"Global Medical Amgen Inc. Thousand Oaks California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco S.","family":"Navetta","sequence":"additional","affiliation":[{"name":"Global Medical Amgen Inc. Thousand Oaks California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brett","family":"Loop","sequence":"additional","affiliation":[{"name":"Global Patient Safety Amgen Inc. Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Feng","family":"Zhang","sequence":"additional","affiliation":[{"name":"Global Medical Amgen Inc. Thousand Oaks California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ani C.","family":"Khodavirdi","sequence":"additional","affiliation":[{"name":"Global Medical Amgen Inc. Thousand Oaks California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Allison","family":"Mann","sequence":"additional","affiliation":[{"name":"Medical Safety Novartis Pharmaceuticals Corporation East Hanover New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahmad","family":"Abdrabboh","sequence":"additional","affiliation":[{"name":"Medical Safety Novartis Pharmaceuticals Corporation East Hanover New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jawed","family":"Kalim","sequence":"additional","affiliation":[{"name":"Medical Safety Novartis Pharmaceuticals Corporation East Hanover New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,9,30]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(14)60685-1"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2017.11.006"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0b013e3181d0cc8b"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-017-0807-1"},{"key":"e_1_2_12_6_1","volume-title":"Aimovig (erenumab\u2010aooe)","year":"2020"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.yrtph.2019.05.013"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000008743"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102418776017"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.799"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.13316"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1705848"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(16)00019-3"},{"key":"e_1_2_12_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.14051"},{"key":"e_1_2_12_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(17)30083-2"},{"key":"e_1_2_12_16_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102418759786"},{"key":"e_1_2_12_17_1","volume-title":"Global Patient Safety","author":"Amgen Inc"},{"key":"e_1_2_12_18_1","volume-title":"Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA\/BE Studies","author":"Food and Drug Administration"},{"key":"e_1_2_12_19_1","volume-title":"Electronic Code of Federal Regulations","author":"US Office of the Federal Register"},{"key":"e_1_2_12_20_1","unstructured":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.Periodic Benefit\u2010Risk Evaluation Report (PBRER); December 17 2012:E2C(R2)."},{"key":"e_1_2_12_21_1","doi-asserted-by":"publisher","DOI":"10.1111\/ene.14715"},{"key":"e_1_2_12_22_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.13684"},{"key":"e_1_2_12_23_1","doi-asserted-by":"crossref","DOI":"10.1212\/WNL.94.15_supplement.4359","article-title":"Cardiovascular safety of fremanezumab in patients with episodic and chronic migraine: a pooled analysis of phase 3 studies","volume":"94","author":"Nahas SJ","year":"2020","journal-title":"Neurology"},{"key":"e_1_2_12_24_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102420905132"},{"key":"e_1_2_12_25_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000009169"},{"key":"e_1_2_12_26_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.13682"},{"key":"e_1_2_12_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)32544-7"},{"key":"e_1_2_12_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(20)30234-9"},{"key":"e_1_2_12_29_1","volume-title":"Hypertension and Negative Control Outcomes in New Users of OnabotulinumtoxinA and Monoclonal Antibodies Targeting the Calcitonin\u2010Gene\u2010Related Peptide Pathway in the Marketscan Early View Claims Database","author":"Amgen Inc"},{"key":"e_1_2_12_30_1","doi-asserted-by":"publisher","DOI":"10.1097\/HJH.0000000000001197"},{"key":"e_1_2_12_31_1","volume-title":"A Phase 2 Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention (NCT01952574)","author":"ClinicalTrials.gov"},{"key":"e_1_2_12_32_1","volume-title":"Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention (STRIVE) (NCT02456740)","author":"ClinicalTrials.gov"},{"key":"e_1_2_12_33_1","volume-title":"Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) Compared to Placebo in Migraine Prevention (ARISE) (NCT02483585)","author":"ClinicalTrials.gov"},{"key":"e_1_2_12_34_1","volume-title":"A Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Chronic Migraine Prevention (NCT02066415)","author":"ClinicalTrials.gov"}],"container-title":["Headache: The Journal of Head and Face Pain"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/head.14208","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/head.14208","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/headachejournal.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/head.14208","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,11,2]],"date-time":"2025-11-02T13:19:56Z","timestamp":1762089596000},"score":1,"resource":{"primary":{"URL":"https:\/\/headachejournal.onlinelibrary.wiley.com\/doi\/10.1111\/head.14208"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,9,30]]},"references-count":33,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2021,10]]}},"alternative-id":["10.1111\/head.14208"],"URL":"https:\/\/doi.org\/10.1111\/head.14208","archive":["Portico"],"relation":{},"ISSN":["0017-8748","1526-4610"],"issn-type":[{"value":"0017-8748","type":"print"},{"value":"1526-4610","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,9,30]]},"assertion":[{"value":"2021-04-03","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-07-19","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-09-30","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}