Anticoagulant Use and Bleeding Risk in Central European Patients with Idiopathic Pulmonary Fibrosis (IPF) Treated with Antifibrotic Therapy: Real-World Data from EMPIRE

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dc.contributor.authorKolonics-Farkas, Abigel M.
dc.contributor.authorSterclova, Martina
dc.contributor.authorMogulkoc, Nesrin
dc.contributor.authorKus, Jan
dc.contributor.authorHajkova, Marta
dc.contributor.authorMuller, Veronika
dc.contributor.authorVasakova, Martina
dc.date.accessioned2020-12-01T11:58:52Z
dc.date.available2020-12-01T11:58:52Z
dc.date.issued2020
dc.departmentEge Üniversitesien_US
dc.description.abstractIntroduction Nintedanib, a tyrosine kinase receptor inhibitor, may be associated with increased bleeding risk. Thus, patients with an inherited predisposition to bleeding, or those receiving therapeutic doses of anticoagulants or high-dose antiplatelet therapy, have been excluded from clinical trials of nintedanib in idiopathic pulmonary fibrosis (IPF). Objective Our objective was to examine real-world bleeding events in patients with IPF treated with antifibrotics, including those receiving anticoagulants and/or antiplatelet therapy. Methods the European MultiPartner IPF Registry (EMPIRE) enrolled 2794 patients with IPF: group A (1828: no anticoagulant or antiplatelet treatment), group B (227: anticoagulant treatment), group C (659: antiplatelet treatment), and group D (80: anticoagulant and antiplatelet treatment). Overall, 673 (24.1%) received nintedanib and 933 (33.4%) received pirfenidone. Bleeding events and their relationship to antifibrotic and anticoagulation treatment were characterized. Results Group A patients, versus those in groups B, C, and D, were typically younger and generally had the lowest comorbidity rates. A higher proportion of patients in groups A and C, versus group B, received nintedanib. Pirfenidone, most common in group D, was more evenly balanced across groups. in patients with reported bleeding events, seven of eight received nintedanib (groups A, C, and D). Bleeding incidence was 3.0, 0, 1.3, and 18.1 per 10,000 patient-years (groups A, B, C, and D, respectively). Conclusion Real-world data from EMPIRE showed that patients on anticoagulant medications received nintedanib less frequently, perhaps based on its mechanism of action. Overall, bleeding incidence was low (0.29%: nintedanib 0.25%; pirfenidone 0.04%) and irrespective of anticoagulant or antiplatelet therapy received (P = 0.072).en_US
dc.description.sponsorshipBoehringer Ingelheim International GmbH (BI)Boehringer Ingelheim; Boehringer Ingelheim International GmbHBoehringer Ingelheimen_US
dc.description.sponsorshipThis study was supported by Boehringer Ingelheim International GmbH (BI). Medical writing assistance was provided by Islay Steele, PhD, of Nucleus Global, which was contracted and funded by Boehringer Ingelheim International GmbH. Boehringer Ingelheim was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations.en_US
dc.identifier.doi10.1007/s40264-020-00978-5en_US
dc.identifier.endpage980en_US
dc.identifier.issn0114-5916
dc.identifier.issn1179-1942
dc.identifier.issue10en_US
dc.identifier.pmid32734423en_US
dc.identifier.scopus2-s2.0-85088829380en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.startpage971en_US
dc.identifier.urihttps://doi.org/10.1007/s40264-020-00978-5
dc.identifier.urihttps://hdl.handle.net/11454/62129
dc.identifier.volume43en_US
dc.identifier.wosWOS:000554054500001en_US
dc.identifier.wosqualityQ1en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherAdis Int Ltden_US
dc.relation.ispartofDrug Safetyen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.titleAnticoagulant Use and Bleeding Risk in Central European Patients with Idiopathic Pulmonary Fibrosis (IPF) Treated with Antifibrotic Therapy: Real-World Data from EMPIREen_US
dc.typeArticleen_US

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