Anticoagulant Use and Bleeding Risk in Central European Patients with Idiopathic Pulmonary Fibrosis (IPF) Treated with A
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ORIGINAL RESEARCH ARTICLE
Anticoagulant Use and Bleeding Risk in Central European Patients with Idiopathic Pulmonary Fibrosis (IPF) Treated with Antifibrotic Therapy: Real‑World Data from EMPIRE Abigél M. Kolonics‑Farkas1 · Martina Šterclová2 · Nesrin Mogulkoc3 · Jan Kus4 · Marta Hájková5 · Veronika Müller1 · Dragana Jovanovic6 · Jasna Tekavec‑Trkanjec7 · Simona Littnerová8 · Karel Hejduk8 · Martina Vašáková2
© The Author(s) 2020
Abstract Introduction 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).
Key Points
Prior Publication Key data from this study were presented at the European Respiratory Society (ERS) Congress 2018 (15–19 September 2018). Electronic supplementary material The online version of this article (https://doi.org/10.1007/s40264-020-00978-5) contains supplementary material, which is available to authorized users. * Abigél M. Kolonics‑Farkas kolonics‑[email protected]‑univ.hu Extended author information available on the last page of the article
Nintedanib, a therapy used to treat patients with idiopathic pulmonary fibrosis (IPF), may increase the risk of bleeding, potentially because of its mechanism of action. Analysis from EMPIRE, a real-world database of patients with IPF, found that nintedanib, compared with pirfen
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