{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T03:06:23Z","timestamp":1791515183250,"version":"4.3.4"},"reference-count":40,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2024,5,8]],"date-time":"2024-05-08T00:00:00Z","timestamp":1715126400000},"content-version":"vor","delay-in-days":7,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2024,5,1]],"date-time":"2024-05-01T00:00:00Z","timestamp":1714521600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100001003","name":"Boehringer Ingelheim","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100001003","id-type":"DOI","asserted-by":"publisher"}]},{"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":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2024,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>This study was undertaken to evaluate the potential risk of acute pancreatitis with empagliflozin in patients with type 2 diabetes (T2D) newly initiating empagliflozin.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Data from two large US claims databases were analyzed in an observational study of patients with T2D receiving metformin who were newly prescribed empagliflozin versus sulfonylurea (SU). Because dipeptidyl peptidase\u20104 inhibitors and glucagon\u2010like peptide\u20101 receptor agonists have been associated with the risk of acute pancreatitis in some studies, patients on these agents were excluded. Using pooled analyses of data from the two databases (2014\u20132021), patients initiating empagliflozin were matched 1:1 within database to patients initiating SU using propensity scores (PS) that incorporated relevant demographic and clinical characteristics. Prespecified sensitivity analyses were performed for design parameters.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The analyses identified 72\u2009661 new users of empagliflozin and 422\u2009018 new users of SUs, with both patient groups on concurrent metformin therapy. Baseline characteristics within treatment groups appeared to be similar across the 72\u2009621 matched pairs. After mean follow\u2010up of ~6\u2009months, incidence rates of acute pancreatitis in the pooled matched cohort were 10.30 (95% confidence interval [CI] 9.29\u201311.39) events per 1000 patient\u2010years (PY) for empagliflozin and 11.65 (95% CI 10.59\u201312.77) events per 1000 PY for SUs. On a background of metformin, patients newly initiating empagliflozin did not have an increased risk of acute pancreatitis compared with those initiating an SU (pooled PS matched hazard ratio 0.88 [0.76\u20131.02]) across 75621.42 PY of follow\u2010up.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The results of this voluntary post\u2010approval safety study provide additional evidence that the use of empagliflozin for the treatment of T2D is not associated with an increased risk of acute pancreatitis.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pds.5800","type":"journal-article","created":{"date-parts":[[2024,5,8]],"date-time":"2024-05-08T21:53:50Z","timestamp":1715205230000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Risk of acute pancreatitis among new users of empagliflozin compared to sulfonylureas in patients with type 2 diabetes: A post\u2010authorization safety study"],"prefix":"10.1002","volume":"33","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8651-0428","authenticated-orcid":false,"given":"Soulmaz","family":"Fazeli Farsani","sequence":"first","affiliation":[{"name":"Global RWE Capability Boehringer Ingelheim International GmbH  Ingelheim Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristy","family":"Iglay","sequence":"additional","affiliation":[{"name":"Real World Evidence and Patient Outcomes CERobs Consulting, LLC  Wrightsville Beach North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ling","family":"Zhang","sequence":"additional","affiliation":[{"name":"Global Integrated Evidence Boehringer Ingelheim Pharmaceuticals Inc.  Ridgefield Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Niyonkuru","sequence":"additional","affiliation":[{"name":"Global Integrated Evidence Boehringer Ingelheim Pharmaceuticals Inc.  Ridgefield Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurieann","family":"Nessralla","sequence":"additional","affiliation":[{"name":"Global Patient Safety and Pharmacovigilence Boehringer Ingelheim Pharmaceuticals Inc.  Ridgefield Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5714-174X","authenticated-orcid":false,"given":"Cynthia J.","family":"Girman","sequence":"additional","affiliation":[{"name":"Real World Evidence and Patient Outcomes CERobs Consulting, LLC  Wrightsville Beach North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,5,8]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262\u2010013\u20100126\u2010x"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/jcpt.13521"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen\u20102018\u2010022577"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12325\u2010017\u20100573\u20100"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12325\u2010020\u201001329\u20107"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2016.08.008"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.diabres.2013.12.052"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.2174\/1574886313666180226103408"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.2174\/1574886314666190206164647"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eclinm.2021.101163"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1080\/14740338.2019.1602116"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.3389\/fendo.2023.1256548"},{"key":"e_1_2_12_14_1","doi-asserted-by":"publisher","DOI":"10.1097\/XCE.0000000000000284"},{"key":"e_1_2_12_15_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2016.1522"},{"key":"e_1_2_12_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12833"},{"key":"e_1_2_12_17_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.g2780"},{"key":"e_1_2_12_18_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc13\u20102983"},{"key":"e_1_2_12_19_1","doi-asserted-by":"publisher","DOI":"10.4291\/wjgp.v5.i4.405"},{"key":"e_1_2_12_20_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11096\u2010022\u201001476\u20107"},{"key":"e_1_2_12_21_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.5313"},{"key":"e_1_2_12_22_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2020.20317"},{"key":"e_1_2_12_23_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0231883"},{"key":"e_1_2_12_24_1","unstructured":"US Food and Drug Administration.April\u2013June 2016 | Potential signals of serious risks\/new safety information identified by the FDA Adverse Event Reporting System (FAERS). Available athttps:\/\/www.fda.gov\/drugs\/questions\u2010and\u2010answers\u2010fdas\u2010adverse\u2010event\u2010reporting\u2010system\u2010faers\/april\u2010june\u20102016\u2010potential\u2010signals\u2010serious\u2010risksnew\u2010safety\u2010information\u2010identified\u2010fda\u2010adverse\u2010eventAccessed 28 June 2023."},{"key":"e_1_2_12_25_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.4943"},{"key":"e_1_2_12_26_1","doi-asserted-by":"publisher","DOI":"10.1177\/1060028018786716"},{"key":"e_1_2_12_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2006.11.023"},{"key":"e_1_2_12_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pan.2020.06.005"},{"key":"e_1_2_12_29_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1463\u20101326.2010.01231.x"},{"key":"e_1_2_12_30_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc08\u20101755"},{"key":"e_1_2_12_31_1","doi-asserted-by":"publisher","DOI":"10.1097\/MPA.0b013e318287cb62"},{"issue":"1","key":"e_1_2_12_32_1","first-page":"45","article-title":"Drug\u2010induced acute pancreatitis: a review","volume":"15","author":"Jones MR","year":"2015","journal-title":"Ochsner J"},{"key":"e_1_2_12_33_1","doi-asserted-by":"publisher","DOI":"10.3748\/wjg.v26.i22.2902"},{"key":"e_1_2_12_34_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc23\u2010S009"},{"key":"e_1_2_12_35_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.5185"},{"key":"e_1_2_12_36_1","unstructured":"GruberS RobinsJ.Personal communication. June 16 2020."},{"key":"e_1_2_12_37_1","unstructured":"LumleyT.Package \u2018rmeta\u2019. Accessed 12 September 2023.https:\/\/cran.r-project.org\/web\/packages\/rmeta\/rmeta.pdf"},{"key":"e_1_2_12_38_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc10\u20100482"},{"key":"e_1_2_12_39_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2021.09.043"},{"key":"e_1_2_12_40_1","doi-asserted-by":"publisher","DOI":"10.1080\/14740338.2023.2284992"},{"key":"e_1_2_12_41_1","doi-asserted-by":"publisher","DOI":"10.1080\/03007995.2020.1761312"}],"container-title":["Pharmacoepidemiology and Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.5800","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/pds.5800","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.5800","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T03:12:11Z","timestamp":1786590731000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pds.5800"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,5]]},"references-count":40,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2024,5]]}},"alternative-id":["10.1002\/pds.5800"],"URL":"https:\/\/doi.org\/10.1002\/pds.5800","archive":["Portico"],"relation":{},"ISSN":["1053-8569","1099-1557"],"issn-type":[{"value":"1053-8569","type":"print"},{"value":"1099-1557","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,5]]},"assertion":[{"value":"2023-10-18","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-04-04","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-05-08","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e5800"}}