Anticoagulant Use and Bleeding Risk in Central European Patients with Idiopathic Pulmonary Fibrosis (IPF) Treated with Antifibrotic Therapy: Real-World Data from EMPIRE
Open Access
- 1 October 2020
- journal article
- research article
- Published by Springer Science and Business Media LLC in Drug Safety
- Vol. 43 (10), 971-980
- https://doi.org/10.1007/s40264-020-00978-5
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).Funding Information
- Boehringer Ingelheim
This publication has 30 references indexed in Scilit:
- Presence of a prothrombotic state in people with idiopathic pulmonary fibrosis: a population-based case–control studyThorax, 2013
- Pulmonary fibrosis is associated with an elevated risk of thromboembolic diseaseEuropean Respiratory Journal, 2011
- Antifibrotic activities of pirfenidone in animal modelsEuropean Respiratory Review, 2011
- Pirfenidone in patients with idiopathic pulmonary fibrosis (CAPACITY): two randomised trialsThe Lancet, 2011
- An Official ATS/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis: Evidence-based Guidelines for Diagnosis and ManagementAmerican Journal of Respiratory and Critical Care Medicine, 2011
- Pirfenidone in idiopathic pulmonary fibrosisEuropean Respiratory Journal, 2009
- The Association between Idiopathic Pulmonary Fibrosis and Vascular DiseaseAmerican Journal of Respiratory and Critical Care Medicine, 2008
- BIBF 1120: Triple Angiokinase Inhibitor with Sustained Receptor Blockade and Good Antitumor EfficacyCancer Research, 2008
- Procoagulant signalling mechanisms in lung inflammation and fibrosis: novel opportunities for pharmacological intervention?British Journal of Pharmacology, 2008
- Sprycel for Chronic Myeloid Leukemia and Philadelphia Chromosome–Positive Acute Lymphoblastic Leukemia Resistant to or Intolerant of Imatinib MesylateClinical Cancer Research, 2008