{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T20:52:49Z","timestamp":1785790369526,"version":"3.56.0"},"reference-count":23,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2023,3,20]],"date-time":"2023-03-20T00:00:00Z","timestamp":1679270400000},"content-version":"vor","delay-in-days":19,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100002429","name":"Amgen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100002429","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004336","name":"Novartis","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004336","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["headachejournal.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Headache"],"published-print":{"date-parts":[[2023,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To assess cardiovascular (CV) safety of erenumab in clinical trial patients associated with degree of CV risk.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Hypertension has been considered a theoretical risk associated with the inhibition of the calcitonin gene\u2010related peptide pathway in migraine management, particularly in a patient population with pre\u2010existing CV risk factors.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Data pooled from four double\u2010blind, randomized trials were used to assess blood pressure (BP) changes and CV safety in patients grouped based on 10\u2010year risk of cardiac, cerebrovascular, and peripheral artery disease as no\u2010risk\u2010factors, low\u2010risk (&gt;0% to \u226410%), moderate\u2010risk (&gt;10% to \u226420%), and high\u2010risk (&gt;20%) categories. CV safety was assessed as ischemic cardiovascular and cerebrovascular adverse events (ICCAE).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      There was no apparent difference between placebo\u2010 (\n                      <jats:italic>N<\/jats:italic>\n                      \u00a0=\u00a01032) and erenumab\u2010treatment groups (70\u2009mg,\n                      <jats:italic>N<\/jats:italic>\n                      \u00a0=\u00a0885; 140\u2009mg,\n                      <jats:italic>N<\/jats:italic>\n                      \u00a0=\u00a0504) in clinical worsening of BP category from baseline to Months 1\u20133 (14% [143\/1032] placebo vs. 13% [114\/885] and 14% [71\/504] for erenumab 70 and 140\u2009mg, respectively) regardless of baseline BP category. The adverse event (AE) profile of erenumab was similar across CV risk categories throughout the long\u2010term analysis. Erenumab\u2010treated patients with high and moderate 10\u2010year CV risk (\n                      <jats:italic>N<\/jats:italic>\n                      \u00a0=\u00a0107) did not experience any ICCAEs during the double\u2010blind treatment period; there was a single ICCAE (a cerebral dural venous sinus thrombosis) observed in the low\u2010risk erenumab group (\n                      <jats:italic>N<\/jats:italic>\n                      \u00a0=\u00a0273). There were no increases in AEs during the long\u2010term extensions of up to 5\u2009years (\n                      <jats:italic>N<\/jats:italic>\n                      \u00a0=\u20092499; 3482 patient\u2010years of exposure to erenumab) with exposure\u2010adjusted incidence rates of cardio\/cerebrovascular disorder AEs of 0.4, 0.5, 0.0, and 1.1 (per 100 patient\u2010years) for no risk factor (\n                      <jats:italic>N<\/jats:italic>\n                      \u00a0=\u20091805), low (\n                      <jats:italic>N<\/jats:italic>\n                      \u00a0=\u2009492), moderate (\n                      <jats:italic>N<\/jats:italic>\n                      \u00a0=\u2009121), and high (\n                      <jats:italic>N<\/jats:italic>\n                      \u00a0=\u200981) 10\u2010year CV risk groups, respectively.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Ischemic CV and cerebrovascular AEs were uncommon and the incidence rates were similar across the 10\u2010year CV risk categories. This analysis helps provide more detail on the CV safety of erenumab.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/head.14485","type":"journal-article","created":{"date-parts":[[2023,3,21]],"date-time":"2023-03-21T02:55:36Z","timestamp":1679367336000},"page":"418-428","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":20,"title":["Evaluation of vascular risk in patients with migraine with and without aura treated with erenumab: Post hoc analysis of pooled long\u2010term clinical trial data"],"prefix":"10.1111","volume":"63","author":[{"given":"David","family":"Kudrow","sequence":"first","affiliation":[{"name":"California Medical Clinic for Headache  Santa Monica California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rima","family":"Dafer","sequence":"additional","affiliation":[{"name":"Rush University Medical Center  Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9486-6790","authenticated-orcid":false,"given":"David W.","family":"Dodick","sequence":"additional","affiliation":[{"name":"Mayo Clinic  Scottsdale Arizona USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amaal","family":"Starling","sequence":"additional","affiliation":[{"name":"Mayo Clinic  Scottsdale Arizona USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica","family":"Ailani","sequence":"additional","affiliation":[{"name":"Department of Neurology MedStar Georgetown University Hospital  Washington DC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carrie","family":"Dougherty","sequence":"additional","affiliation":[{"name":"Department of Neurology MedStar Georgetown University Hospital  Washington DC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kavita","family":"Kalidas","sequence":"additional","affiliation":[{"name":"University of South Florida  Tampa Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Feng","family":"Zhang","sequence":"additional","affiliation":[{"name":"Amgen Inc.  Thousand Oaks California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rohini","family":"Jeswani","sequence":"additional","affiliation":[{"name":"Amgen Inc.  Thousand Oaks California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nishil","family":"Patel","sequence":"additional","affiliation":[{"name":"Amgen Inc.  Thousand Oaks California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ani C.","family":"Khodavirdi","sequence":"additional","affiliation":[{"name":"Amgen Inc.  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