{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,5]],"date-time":"2026-11-05T23:08:08Z","timestamp":1793920088333,"version":"4.8.0"},"reference-count":39,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2019,11,13]],"date-time":"2019-11-13T00:00:00Z","timestamp":1573603200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100004312","name":"Eli Lilly and Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004312","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["headachejournal.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Headache"],"published-print":{"date-parts":[[2020,1]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>Blood pressure (BP), pulse, electrocardiogram (ECG), and clinical cardiovascular (CV) outcomes in patients with episodic or chronic migraine treated for up to 6\u00a0months with galcanezumab compared to placebo were evaluated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Calcitonin gene\u2010related peptide, a potent microvascular vasodilator, has a hypothesized protective role in CV health. Increased CV risks have been reported in patients with migraine.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In 2 similarly designed episodic migraine 6\u2010month studies and 1 chronic migraine 3\u2010month study, data from patients randomized (1:1:2) to subcutaneous injection of galcanezumab 120\u00a0mg\/month (following initial 240\u00a0mg loading dose) or 240\u00a0mg\/month or placebo were pooled. Treatment comparisons for cardiovascular treatment\u2010emergent adverse events (CV TEAE) and categorical and mean changes in BP, pulse, and ECG were evaluated using the Cochran\u2010Mantel\u2010Haenszel test. Mean changes from baseline in BP, pulse, and ECG were evaluated using the analysis of covariance model.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Overall, among galcanezumab 120\u00a0mg (n\u00a0=\u00a0705) and 240\u00a0mg (n\u00a0=\u00a0730), and placebo (n\u00a0=\u00a01451) groups, the percentage of patients reporting \u22651 CV TEAE was low and was similar between the galcanezumab 120\u00a0mg (2.6%; odds ratio [OR]\u00a0=\u00a00.9; 95% confidence interval [CI]: 0.5,1.5) and galcanezumab 240\u00a0mg (3.3%; OR\u00a0=\u00a01.1; 95% CI: 0.7,1.9), and placebo (2.9%) groups. The frequency of any individual CV TEAE, broad or narrow term, was \u22641.4%. The CV\u2010related serious adverse events that occurred in the galcanezumab 240\u00a0mg group (n\u00a0=\u00a03; acute myocardial infarction, pulmonary embolism, and transient ischemic attack) and placebo group (n\u00a0=\u00a03; pulmonary embolism, deep vein thrombosis, and myocardial infarction) were not considered treatment related. Four placebo\u2010 and 1 galcanezumab\u2010treated patient discontinued due to a CV TEAE. Least squares mean and categorical changes from baseline in BP, pulse, and QT\u00a0interval corrected using Fridericia\u2019s correction were similar across treatment groups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In this 6\u2010month treatment trial, the percentages of galcanezumab\u2010 and placebo\u2010treated patients that reported CV TEAEs or serious adverse events were low and similar between groups with few discontinuations. Thus, no clinically meaningful treatment group differences were observed for changes in BP, pulse, or ECG parameters. Additional longer\u2010term studies in a broader and larger cohort are required to better characterize CV safety.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/head.13684","type":"journal-article","created":{"date-parts":[[2019,11,13]],"date-time":"2019-11-13T05:03:05Z","timestamp":1573621385000},"page":"110-123","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":47,"title":["Evaluation of Cardiovascular Outcomes in Adult Patients With Episodic or Chronic Migraine Treated With Galcanezumab: Data From Three Phase 3, Randomized, Double\u2010Blind, Placebo\u2010Controlled EVOLVE\u20101, EVOLVE\u20102, and REGAIN Studies"],"prefix":"10.1111","volume":"60","author":[{"given":"Tina M.","family":"Oakes","sequence":"first","affiliation":[{"name":"Eli Lilly and Company Indianapolis IN 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