{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,17]],"date-time":"2026-10-17T22:57:48Z","timestamp":1792277868889,"version":"4.4.0"},"reference-count":36,"publisher":"SAGE Publications","issue":"9","license":[{"start":{"date-parts":[[2021,4,19]],"date-time":"2021-04-19T00:00:00Z","timestamp":1618790400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Cephalalgia"],"published-print":{"date-parts":[[2021,8]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To examine the safety and efficacy of ubrogepant for acute treatment of migraine across cardiovascular (CV) disease risk categories.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>ACHIEVE I and II were multicenter, double-blind, single-attack, phase 3 trials in adults with migraine, with or without aura. Participants were randomized 1:1:1 to placebo or ubrogepant (50 or 100\u2009mg in ACHIEVE I; 25 or 50\u2009mg in ACHIEVE II), to treat one migraine attack of moderate or severe headache pain intensity. This post-hoc analysis pooled data from ubrogepant 50\u2009mg and placebo groups from the ACHIEVE trials to examine the safety and efficacy of ubrogepant by baseline cardiovascular disease risk factors. Using a cardiovascular risk assessment algorithm, participants were categorized as having no cardiovascular risk, low cardiovascular risk or moderate-high cardiovascular risk at baseline. Treatment-emergent adverse events were documented 48 h and 30 days after taking the trial medication. Co-primary efficacy outcomes were 2-h pain freedom and 2-h absence of most bothersome migraine-associated symptom.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Overall, 3358 participants were randomized in the ACHIEVE trials (n\u2009=\u20092901 safety population; n\u2009=\u20092682 modified intent-to-treat population). In the safety population, 11% of participants were categorized as moderate-high (n\u2009=\u2009311), 32% low (n\u2009=\u2009920), and 58% no cardiovascular risk factors (n\u2009=\u20091670). The proportion of ubrogepant participants reporting a treatment-emergent adverse event was comparable across risk categories and similar to placebo. The treatment effects of ubrogepant versus placebo were consistent across cardiovascular risk categories for all efficacy outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The safety and efficacy of ubrogepant for the acute treatment of a single migraine attack did not differ by the presence of major cardiovascular risk factors. No evidence of increased treatment-emergent adverse events or cardiac system organ class adverse events with \u22652 major cardiovascular risk factors and no safety concerns were identified. Trial Registration: ACHIEVE I ClinicalTrials.gov number, NCT02828020; ACHIEVE II ClinicalTrials.gov number, NCT02867709<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/03331024211000311","type":"journal-article","created":{"date-parts":[[2021,4,20]],"date-time":"2021-04-20T01:22:55Z","timestamp":1618881775000},"page":"979-990","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":35,"title":["Safety and efficacy of ubrogepant in participants with major cardiovascular risk factors in two single-attack phase 3 randomized trials: ACHIEVE I and II"],"prefix":"10.1177","volume":"41","author":[{"given":"Susan","family":"Hutchinson","sequence":"first","affiliation":[{"name":"Orange County Migraine & Headache Center, Irvine, CA, 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":"Thomas Jefferson University Hospital, Philadelphia, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew M","family":"Blumenfeld","sequence":"additional","affiliation":[{"name":"Headache Center of Southern California, Carlsbad, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard B","family":"Lipton","sequence":"additional","affiliation":[{"name":"Albert Einstein College of Medicine, Bronx, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaifeng","family":"Lu","sequence":"additional","affiliation":[{"name":"AbbVie, Madison, NJ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sung Yun","family":"Yu","sequence":"additional","affiliation":[{"name":"AbbVie, Madison, NJ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence","family":"Severt","sequence":"additional","affiliation":[{"name":"AbbVie, Madison, NJ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2021,4,19]]},"reference":[{"key":"bibr1-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1111\/head.12550"},{"key":"bibr2-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1111\/head.12962"},{"key":"bibr3-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1111\/head.13179"},{"key":"bibr4-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1161\/01.cir.0000437741.48606.98"},{"key":"bibr5-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000009324"},{"key":"bibr6-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1813049"},{"key":"bibr7-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2019.16711"},{"key":"bibr8-03331024211000311","first-page":"629","volume-title":"Cephalalgia","volume":"33","year":"2013"},{"key":"bibr9-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1111\/head.12472"},{"key":"bibr10-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1111\/head.13588"},{"key":"bibr11-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1111\/head.12154"},{"key":"bibr12-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1038\/s41582-018-0003-1"},{"key":"bibr13-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1016\/j.mayocp.2019.11.025"},{"key":"bibr14-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1046\/j.1526-4610.2002.0420s1003.x"},{"key":"bibr15-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1111\/head.13407"},{"key":"bibr16-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1111\/head.12601"},{"key":"bibr17-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1177\/0333102410383058"},{"key":"bibr18-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1111\/head.12404"},{"key":"bibr19-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1111\/head.12198"},{"key":"bibr20-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1177\/0333102420905307"},{"key":"bibr21-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1111\/j.1526-4610.2004.04105.x"},{"key":"bibr22-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1111\/j.1526-4610.2011.02050.x"},{"key":"bibr23-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1111\/head.12645"},{"key":"bibr24-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1111\/j.1526-4610.2010.01728.x"},{"key":"bibr25-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1111\/head.12499"},{"key":"bibr26-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1111\/head.13459"},{"key":"bibr27-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1177\/0333102418768095"},{"key":"bibr28-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(19)31606-X"},{"key":"bibr29-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1811090"},{"key":"bibr30-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1111\/head.13682"},{"key":"bibr31-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1152\/physrev.00034.2013"},{"key":"bibr32-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1016\/0167-0115(86)90071-6"},{"key":"bibr33-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1002\/ana.25831"},{"key":"bibr34-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1007\/s13311-018-0617-4"},{"key":"bibr35-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1111\/head.13316"},{"key":"bibr36-03331024211000311","doi-asserted-by":"publisher","DOI":"10.1093\/brain\/awz134"}],"container-title":["Cephalalgia"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/03331024211000311","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/03331024211000311","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/03331024211000311","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T14:49:02Z","timestamp":1777387742000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/03331024211000311"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,4,19]]},"references-count":36,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2021,8]]}},"alternative-id":["10.1177\/03331024211000311"],"URL":"https:\/\/doi.org\/10.1177\/03331024211000311","relation":{},"ISSN":["0333-1024","1468-2982"],"issn-type":[{"value":"0333-1024","type":"print"},{"value":"1468-2982","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,4,19]]}}}