{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,18]],"date-time":"2026-07-18T06:39:41Z","timestamp":1784356781621,"version":"3.55.0"},"reference-count":34,"publisher":"SAGE Publications","issue":"8","license":[{"start":{"date-parts":[[2022,3,25]],"date-time":"2022-03-25T00:00:00Z","timestamp":1648166400000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Teva Branded Pharmaceuticals R&D"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Cephalalgia"],"published-print":{"date-parts":[[2022,7]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Fremanezumab, a fully humanized monoclonal antibody that selectively targets calcitonin gene-related peptide, has demonstrated efficacy for preventive treatment of episodic and chronic migraine. Since calcitonin gene-related peptide is expressed within the cardio- and cerebrovascular system and may have cardioprotective effects, it is critical to understand the cardio- and cerebrovascular safety of fremanezumab.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This was a pooled analysis of three randomized, double-blind, placebo-controlled, phase 3, 12-week trials in which patients with episodic migraine or chronic migraine received quarterly fremanezumab, monthly fremanezumab, or placebo. Incidences of overall and serious adverse events were analyzed. Cardio- and cerebrovascular adverse events (CVAEs) were analyzed in subgroups stratified by cardio- and cerebrovascular medical history, cardiovascular risk factors (CVRFs), and use of cardio- and cerebrovascular medications or triptans.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Two thousand, eight hundred and forty-two patients were included in the study. Overall (58\u201365%) and serious adverse events (&lt;1\u20132%) occurred in similar proportions across fremanezumab and placebo groups. CVAEs were infrequent, regardless of cardio- and cerebrovascular medical history (2\u20136%). CVAEs occurred in low, similar proportions of patients with CVRFs and those using cardio- and cerebrovascular medications or triptans. No cardio- and cerebrovascular signals were identified.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Fremanezumab demonstrated a favorable overall and cardio- and cerebrovascular safety profile in more than 2800 patients with episodic migraine or chronic migraine, regardless of cardio- and cerebrovascular medical history, CVRFs, or medication use. Trial Registrations: NCT02629861 (HALO EM, https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02629861 ), NCT02621931 (HALO CM, https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02621931 ), NCT03308968 (FOCUS, https:\/\/clinicaltrials.gov\/ct2\/ show\/NCT03308968 )<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/03331024221076485","type":"journal-article","created":{"date-parts":[[2022,3,25]],"date-time":"2022-03-25T03:00:54Z","timestamp":1648177254000},"page":"769-780","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":13,"title":["Safety and tolerability of fremanezumab in patients with episodic and chronic migraine: a pooled analysis of phase 3 studies"],"prefix":"10.1177","volume":"42","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6556-8612","authenticated-orcid":false,"given":"Hans Christoph","family":"Diener","sequence":"first","affiliation":[{"name":"Institute for Medical Informatics, Biometry, and Epidemiology, Medical Faculty of the University Duisburg-Essen, Essen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"McAllister","sequence":"additional","affiliation":[{"name":"New England Institute for Neurology and Headache, Stamford, CT, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tim P","family":"J\u00fcrgens","sequence":"additional","affiliation":[{"name":"Headache Center North-East, Department of Neurology, University Medical Center Rostock, Rostock, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoel","family":"Kessler","sequence":"additional","affiliation":[{"name":"Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaoping","family":"Ning","sequence":"additional","affiliation":[{"name":"Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joshua M","family":"Cohen","sequence":"additional","affiliation":[{"name":"Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Verena Ramirez","family":"Campos","sequence":"additional","affiliation":[{"name":"Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steve","family":"Barash","sequence":"additional","affiliation":[{"name":"Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9467-5567","authenticated-orcid":false,"given":"Stephen D","family":"Silberstein","sequence":"additional","affiliation":[{"name":"Jefferson Headache Center, Philadelphia, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2022,3,25]]},"reference":[{"key":"bibr1-03331024221076485","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(18)30322-3"},{"key":"bibr2-03331024221076485","doi-asserted-by":"publisher","DOI":"10.1111\/head.12755"},{"key":"bibr3-03331024221076485","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0130733"},{"key":"bibr4-03331024221076485","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000009169"},{"key":"bibr5-03331024221076485","doi-asserted-by":"publisher","DOI":"10.1111\/head.12055"},{"key":"bibr6-03331024221076485","doi-asserted-by":"publisher","DOI":"10.1080\/14737175.2020.1772758"},{"key":"bibr7-03331024221076485","doi-asserted-by":"publisher","DOI":"10.1111\/head.13305"},{"key":"bibr8-03331024221076485","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-019-0979-y"},{"key":"bibr9-03331024221076485","doi-asserted-by":"publisher","DOI":"10.3389\/fphys.2018.01249"},{"key":"bibr10-03331024221076485","doi-asserted-by":"publisher","DOI":"10.1002\/ana.25831"},{"key":"bibr11-03331024221076485","doi-asserted-by":"publisher","DOI":"10.1111\/j.1526-4610.2004.04078.x"},{"key":"bibr12-03331024221076485","first-page":"8538101","volume":"2016","author":"Alwhaibi M","year":"2016","journal-title":"Pain Res Treat"},{"key":"bibr13-03331024221076485","doi-asserted-by":"publisher","DOI":"10.1177\/0333102414550416"},{"key":"bibr14-03331024221076485","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-2982.2003.00713.x"},{"key":"bibr15-03331024221076485","doi-asserted-by":"publisher","DOI":"10.1111\/j.1526-4610.2004.04122.x"},{"key":"bibr16-03331024221076485","unstructured":"Teva Pharmaceuticals. AJOVY (fremanezumab-vfrm), prescribing information, https:\/\/www.ajovyhcp.com\/globalassets\/ajovy\/ajovy-pi.pdf. North Wales, PA: Teva Pharmaceuticals USA, Inc. 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