{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,18]],"date-time":"2026-10-18T10:44:31Z","timestamp":1792320271170,"version":"4.4.0"},"reference-count":21,"publisher":"American Diabetes Association","issue":"4","license":[{"start":{"date-parts":[[2024,2,16]],"date-time":"2024-02-16T00:00:00Z","timestamp":1708041600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.diabetesjournals.org\/journals\/pages\/license"}],"funder":[{"DOI":"10.13039\/100004339","name":"Sanofi","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004339","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["diabetesjournals.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2024,4,1]]},"abstract":"<jats:sec>\n                  <jats:title>OBJECTIVE<\/jats:title>\n                  <jats:p>To assess risk of anaphylaxis among patients with type 2 diabetes mellitus who are initiating therapy with a glucagon-like peptide 1 receptor agonist (GLP-1 RA), with a focus on those starting lixisenatide therapy.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>RESEARCH DESIGN AND METHODS<\/jats:title>\n                  <jats:p>A cohort study was conducted in three large, U.S. claims databases (2017\u20132021). Adult (aged \u226518 years) new users of a GLP-1 RA who had type 2 diabetes mellitus and \u22656 months enrollment in the database before GLP-1 RA initiation (start of follow-up) were included. GLP-1 RAs evaluated were lixisenatide, an insulin glargine\/lixisenatide fixed-ratio combination (FRC), exenatide, liraglutide or insulin degludec\/liraglutide FRC, dulaglutide, and semaglutide (injectable and oral). The first anaphylaxis event during follow-up was identified using a validated algorithm. Incidence rates (IRs) and 95% CIs were calculated within each medication cohort. The unadjusted IR ratio (IRR) comparing anaphylaxis rates in the lixisenatide cohort with all other GLP-1 RAs combined was analyzed post hoc.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>RESULTS<\/jats:title>\n                  <jats:p>There were 696,089 new users with 456,612 person-years of exposure to GLP-1 RAs. Baseline demographics, comorbidities, and use of other prescription medications in the 6 months before the index date were similar across medication cohorts. IRs (95% CIs) per 10,000 person-years were 1.0 (0.0\u20135.6) for lixisenatide, 6.0 (3.6\u20139.4) for exenatide, 5.1 (3.7\u20137.0) for liraglutide, 3.9 (3.1\u20134.8) for dulaglutide, and 3.6 (2.6\u20134.9) for semaglutide. The IRR (95% CI) for the anaphylaxis rate for the lixisenatide cohort compared with the pooled other GLP-1 RA cohort was 0.24 (0.01\u20131.35).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>CONCLUSIONS<\/jats:title>\n                  <jats:p>Anaphylaxis is rare with GLP-1 RAs. Lixisenatide is unlikely to confer higher risk of anaphylaxis than other GLP-1 RAs.<\/jats:p>\n               <\/jats:sec>","DOI":"10.2337\/dc23-1911","type":"journal-article","created":{"date-parts":[[2024,2,16]],"date-time":"2024-02-16T19:11:26Z","timestamp":1708110686000},"page":"712-719","update-policy":"https:\/\/doi.org\/10.2337\/ada-journal-policies","source":"Crossref","is-referenced-by-count":9,"title":["Risk of Anaphylaxis Among New Users of GLP-1 Receptor Agonists: A Cohort Study"],"prefix":"10.2337","volume":"47","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5201-1794","authenticated-orcid":false,"given":"Mary S.","family":"Anthony","sequence":"first","affiliation":[{"name":"1RTI Health Solutions, Research Triangle Park, NC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vanita R.","family":"Aroda","sequence":"additional","affiliation":[{"name":"2Brigham and Women\u2019s Hospital, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lauren E.","family":"Parlett","sequence":"additional","affiliation":[{"name":"3Carelon Research, Wilmington, DE"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leila","family":"Djebarri","sequence":"additional","affiliation":[{"name":"4Sanofi, Chilly-Mazarin, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sofia","family":"Berreghis","sequence":"additional","affiliation":[{"name":"4Sanofi, Chilly-Mazarin, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian","family":"Calingaert","sequence":"additional","affiliation":[{"name":"1RTI Health Solutions, Research Triangle Park, NC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel C.","family":"Beachler","sequence":"additional","affiliation":[{"name":"3Carelon Research, Wilmington, DE"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher L.","family":"Crowe","sequence":"additional","affiliation":[{"name":"3Carelon Research, Wilmington, DE"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine B.","family":"Johannes","sequence":"additional","affiliation":[{"name":"5RTI Health Solutions, Waltham, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juhaeri","family":"Juhaeri","sequence":"additional","affiliation":[{"name":"6Sanofi, Inc., Bridgewater, NJ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephan","family":"Lanes","sequence":"additional","affiliation":[{"name":"3Carelon Research, Wilmington, DE"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chunshen","family":"Pan","sequence":"additional","affiliation":[{"name":"6Sanofi, Inc., Bridgewater, NJ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenneth J.","family":"Rothman","sequence":"additional","affiliation":[{"name":"5RTI Health Solutions, Waltham, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine W.","family":"Saltus","sequence":"additional","affiliation":[{"name":"5RTI Health Solutions, Waltham, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathleen E.","family":"Walsh","sequence":"additional","affiliation":[{"name":"7Boston Children\u2019s Hospital, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1167","published-online":{"date-parts":[[2024,2,16]]},"reference":[{"key":"2024032517511097100_B1","doi-asserted-by":"crossref","first-page":"13","DOI":"10.1016\/S2213-8587(19)30382-1","article-title":"Exendin-based glucagon-like peptide-1 receptor agonists and anaphylactic reactions: a pharmacovigilance analysis","volume":"8","author":"Pradhan","year":"2020","journal-title":"Lancet Diabetes Endocrinol"},{"key":"2024032517511097100_B2","doi-asserted-by":"crossref","first-page":"317","DOI":"10.1111\/dom.12596","article-title":"Review of head-to-head comparisons of glucagon-like peptide-1 receptor agonists","volume":"18","author":"Madsbad","year":"2016","journal-title":"Diabetes Obes Metab"},{"key":"2024032517511097100_B3","doi-asserted-by":"crossref","first-page":"1352","DOI":"10.1093\/aje\/kwac021","article-title":"Glucagon-like peptide 1 receptor agonists and risk of anaphylactic reaction among patients with type 2 diabetes: a multisite population-based cohort study","volume":"191","author":"Pradhan","year":"2022","journal-title":"Am J Epidemiol"},{"key":"2024032517511097100_B4","doi-asserted-by":"crossref","first-page":"317","DOI":"10.1001\/archinte.164.3.317","article-title":"A population-based study of the incidence, cause, and severity of anaphylaxis in the United Kingdom","volume":"164","author":"Peng","year":"2004","journal-title":"Arch Intern Med"},{"key":"2024032517511097100_B5","doi-asserted-by":"crossref","first-page":"1205","DOI":"10.1002\/pds.3505","article-title":"Validation of anaphylaxis in the Food and Drug Administration\u2019s Mini-Sentinel","volume":"22","author":"Walsh","year":"2013","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"2024032517511097100_B6","author":"Sanofi U.S","year":"2022"},{"key":"2024032517511097100_B7","author":"Sanofi U.S","year":"2022"},{"key":"2024032517511097100_B8","doi-asserted-by":"crossref","first-page":"918","DOI":"10.1002\/pds.5257","article-title":"Development and validation of a predictive model algorithm to identify anaphylaxis in adults with type 2 diabetes in U.S. administrative claims data","volume":"30","author":"Beachler","year":"2021","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"2024032517511097100_B9","doi-asserted-by":"crossref","first-page":"457","DOI":"10.1002\/sim.4780100317","article-title":"Confidence intervals for weighted sums of Poisson parameters","volume":"10","author":"Dobson","year":"1991","journal-title":"Stat Med"},{"key":"2024032517511097100_B10","doi-asserted-by":"crossref","first-page":"291","DOI":"10.1002\/pds.1200","article-title":"Sensitivity analysis and external adjustment for unmeasured confounders in epidemiologic database studies of therapeutics","volume":"15","author":"Schneeweiss","year":"2006","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"2024032517511097100_B11","author":"Sanofi Groupe","year":"2021"},{"key":"2024032517511097100_B12","author":"Sanofi Groupe","year":"2022"},{"key":"2024032517511097100_B13","author":"AstraZeneca AB","year":"2022"},{"key":"2024032517511097100_B14","author":"AstraZeneca AB","year":"2022"},{"key":"2024032517511097100_B15","author":"Novo Nordisk A\/S","year":"2021"},{"key":"2024032517511097100_B16","author":"Novo Nordisk A\/S","year":"2020"},{"key":"2024032517511097100_B17","author":"Eli Lilly","year":"2021"},{"key":"2024032517511097100_B18","author":"Novo Nordisk A\/S","year":"2022"},{"key":"2024032517511097100_B19","author":"Novo Nordisk A\/S","year":"2022"},{"key":"2024032517511097100_B20","doi-asserted-by":"crossref","first-page":"700","DOI":"10.1002\/pds.5601","article-title":"Validation to correct for outcome misclassification bias","volume":"32","author":"Lanes","year":"2023","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"2024032517511097100_B21","doi-asserted-by":"crossref","first-page":"1009","DOI":"10.1002\/pds.3856","article-title":"Identifying health outcomes in healthcare databases","volume":"24","author":"Lanes","year":"2015","journal-title":"Pharmacoepidemiol Drug Saf"}],"container-title":["Diabetes Care"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/diabetesjournals.org\/care\/article-pdf\/47\/4\/712\/751773\/dc231911.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/diabetesjournals.org\/care\/article-pdf\/47\/4\/712\/751773\/dc231911.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,3,25]],"date-time":"2024-03-25T17:54:44Z","timestamp":1711389284000},"score":1,"resource":{"primary":{"URL":"https:\/\/diabetesjournals.org\/care\/article\/47\/4\/712\/154237\/Risk-of-Anaphylaxis-Among-New-Users-of-GLP-1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,2,16]]},"references-count":21,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2024,2,16]]},"published-print":{"date-parts":[[2024,4,1]]}},"URL":"https:\/\/doi.org\/10.2337\/dc23-1911","relation":{},"ISSN":["0149-5992","1935-5548"],"issn-type":[{"value":"0149-5992","type":"print"},{"value":"1935-5548","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,2,16]]}}}