{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T19:40:49Z","timestamp":1792006849274,"version":"4.4.0"},"reference-count":22,"publisher":"European Respiratory Society (ERS)","issue":"3","license":[{"start":{"date-parts":[[2019,7,8]],"date-time":"2019-07-08T00:00:00Z","timestamp":1562544000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100001003","name":"Boehringer Ingelheim","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100001003","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["publications.ersnet.org"],"crossmark-restriction":true},"short-container-title":["Eur Respir J"],"published-print":{"date-parts":[[2019,9]]},"abstract":"<jats:p>Nintedanib is a tyrosine kinase inhibitor used to treat idiopathic pulmonary fibrosis (IPF). We investigated the cardiovascular safety of nintedanib using pooled data from the TOMORROW and INPULSIS trials.<\/jats:p><jats:p>Cardiovascular events were assessed<jats:italic>post hoc<\/jats:italic>in patients with a history of atherosclerotic cardiovascular disease (CVD) and\/or one or more cardiovascular risk factors at baseline (\u201chigher cardiovascular risk\u201d) and patients with no history of atherosclerotic CVD and no cardiovascular risk factors at baseline (\u201clower cardiovascular risk\u201d).<\/jats:p><jats:p>Incidence rates were calculated for 1231 patients (n=723 nintedanib and n=508 placebo), of whom 89.9% had higher cardiovascular risk. Incidence rates of major adverse cardiovascular events were similar in the nintedanib and placebo groups in patients with higher cardiovascular risk (3.88 (95% CI 2.58\u20135.84) and 3.49 (95% CI 2.10\u20135.79) per 100 patient-years, respectively) and lower cardiovascular risk (4.78 (95% CI 1.54\u201314.82) and 5.37 (95% CI 1.73\u201316.65) per 100 patient-years, respectively). Incidence rates of myocardial infarction in the nintedanib and placebo groups, respectively, were 3.03 (95% CI 1.91\u20134.81) and 1.16 (95% CI 0.48\u20132.79) per 100 patient-years in patients with higher cardiovascular risk and 1.59 (95% CI 0.22\u201311.29) and 1.78 (95% CI 0.25\u201312.64) per 100 patient-years in patients with lower cardiovascular risk. Incidence rates of other ischaemic heart disease in the nintedanib and placebo groups, respectively, were 1.85 (95% CI 1.02\u20133.34) and 3.28 (95% CI 1.94\u20135.54) per 100 patient-years in patients with higher cardiovascular risk and 0 and 1.80 (95% CI 0.25\u201312.78) per 100 patient-years in patients with lower cardiovascular risk.<\/jats:p><jats:p>These data help to establish the cardiovascular safety profile of nintedanib in IPF.<\/jats:p>","DOI":"10.1183\/13993003.01797-2018","type":"journal-article","created":{"date-parts":[[2019,7,9]],"date-time":"2019-07-09T04:25:12Z","timestamp":1562646312000},"page":"1801797","update-policy":"https:\/\/doi.org\/10.1183\/ers-crossmark-policy","source":"Crossref","is-referenced-by-count":34,"title":["Cardiovascular safety of nintedanib in subgroups by cardiovascular risk at baseline in the TOMORROW and INPULSIS\u00a0trials"],"prefix":"10.1183","volume":"54","author":[{"given":"Imre","family":"Noth","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marlies","family":"Wijsenbeek","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3837-1467","authenticated-orcid":false,"given":"Martin","family":"Kolb","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Bonella","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lizette","family":"Moros","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Wachtlin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tamera J.","family":"Corte","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"81","published-online":{"date-parts":[[2019,7,8]]},"reference":[{"key":"2024102101031544000_54.3.1801797.1","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.2009-040GL"},{"key":"2024102101031544000_54.3.1801797.2","doi-asserted-by":"publisher","DOI":"10.3111\/13696998.2012.680553"},{"key":"2024102101031544000_54.3.1801797.3","doi-asserted-by":"publisher","DOI":"10.1016\/j.rmed.2014.01.008"},{"key":"2024102101031544000_54.3.1801797.4","doi-asserted-by":"publisher","DOI":"10.1183\/13993003.02316-2014"},{"key":"2024102101031544000_54.3.1801797.5","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0151425"},{"key":"2024102101031544000_54.3.1801797.6","doi-asserted-by":"crossref","first-page":"317","DOI":"10.1159\/000486286","article-title":"Statin therapy and outcomes in trials of nintedanib in idiopathic pulmonary fibrosis","volume":"95","author":"Kreuter","year":"2018","journal-title":"Respiration"},{"key":"2024102101031544000_54.3.1801797.7","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehw106"},{"key":"2024102101031544000_54.3.1801797.8","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1402584"},{"key":"2024102101031544000_54.3.1801797.9","doi-asserted-by":"publisher","DOI":"10.1158\/0008-5472.CAN-07-6307"},{"key":"2024102101031544000_54.3.1801797.10","doi-asserted-by":"crossref","first-page":"209","DOI":"10.1124\/jpet.113.208223","article-title":"Antifibrotic and anti-inflammatory activity of the tyrosine kinase inhibitor nintedanib in experimental models of lung fibrosis","volume":"349","author":"Wollin","year":"2014","journal-title":"J Pharmacol Exp Med"},{"key":"2024102101031544000_54.3.1801797.11","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-015-0300-1"},{"key":"2024102101031544000_54.3.1801797.12","doi-asserted-by":"crossref","first-page":"116","DOI":"10.1186\/s12931-015-0276-5","article-title":"Safety, tolerability and appropriate use of nintedanib in idiopathic pulmonary fibrosis","volume":"16","author":"Corte","year":"2015","journal-title":"Respir Res"},{"key":"2024102101031544000_54.3.1801797.13","unstructured":"Boehringer Ingelheim Pharmaceuticals, Inc. OFEV (nintedanib). Prescribing information. 2018. https:\/\/docs.boehringer-ingelheim.com\/Prescribing%20Information\/PIs\/Ofev\/ofev.pdf Date last accessed: August 16, 2018."},{"key":"2024102101031544000_54.3.1801797.14","unstructured":"Boehringer Ingelheim . OFEV (nintedanib). Summary of product characteristics. 2018. https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/ofev-epar-product-information_en.pdf Date last accessed: August 16, 2018."},{"key":"2024102101031544000_54.3.1801797.15","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1103690"},{"key":"2024102101031544000_54.3.1801797.16","first-page":"OA3402","article-title":"Long-term nintedanib treatment in idiopathic pulmonary fibrosis (IPF): new data from INPULSIS-ON","volume":"50","author":"Crestani","year":"2017","journal-title":"Eur Respir J"},{"key":"2024102101031544000_54.3.1801797.17","doi-asserted-by":"publisher","DOI":"10.1159\/000448288"},{"key":"2024102101031544000_54.3.1801797.18","doi-asserted-by":"publisher","DOI":"10.3390\/jcm5090078"},{"key":"2024102101031544000_54.3.1801797.19","doi-asserted-by":"crossref","first-page":"1171","DOI":"10.1111\/resp.13024","article-title":"Pirfenidone and nintedanib for pulmonary fibrosis in clinical practice: tolerability and adverse drug reactions","volume":"22","author":"Galli","year":"2017","journal-title":"Respirology"},{"key":"2024102101031544000_54.3.1801797.20","doi-asserted-by":"publisher","DOI":"10.1183\/13993003.02106-2017"},{"key":"2024102101031544000_54.3.1801797.21","doi-asserted-by":"crossref","first-page":"41","DOI":"10.1186\/s40169-017-0172-3","article-title":"Early clinical experiences with nintedanib in three UK tertiary interstitial lung disease centres","volume":"6","author":"Toellner","year":"2017","journal-title":"Clin Transl Med"},{"key":"2024102101031544000_54.3.1801797.22","doi-asserted-by":"crossref","first-page":"301","DOI":"10.1159\/000485933","article-title":"Real-world experience with nintedanib in patients with idiopathic pulmonary fibrosis","volume":"95","author":"Brunnemer","year":"2018","journal-title":"Respiration"}],"container-title":["European Respiratory Journal"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1183\/13993003.01797-2018","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,2,24]],"date-time":"2025-02-24T07:39:48Z","timestamp":1740382788000},"score":1,"resource":{"primary":{"URL":"https:\/\/publications.ersnet.org\/lookup\/doi\/10.1183\/13993003.01797-2018"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,7,8]]},"references-count":22,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2019,9,30]]},"published-print":{"date-parts":[[2019,9]]}},"alternative-id":["10.1183\/13993003.01797-2018"],"URL":"https:\/\/doi.org\/10.1183\/13993003.01797-2018","relation":{},"ISSN":["0903-1936","1399-3003"],"issn-type":[{"value":"0903-1936","type":"print"},{"value":"1399-3003","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,7,8]]}}}