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@article{1674002,
author = {KolonicsandFarkas, Abigel M. and Sterclova, Martina and Mogulkoc, Nesrin and Kus, Jan and Hajkova, Marta and Muller, Veronika and Jovanovic, Dragana and TekavecandTrkanjec, Jasna and Littnerová, Simona and Hejduk, Karel and Vasakova, Martina},
article_location = {Aucland},
article_number = {10},
doi = {http://dx.doi.org/10.1007/s40264-020-00978-5},
keywords = {CLINICAL-PRACTICE; PIRFENIDONE; NINTEDANIB; INHIBITOR; DIAGNOSIS; SAFETY},
language = {eng},
issn = {0114-5916},
journal = {DRUG SAFETY},
title = {Anticoagulant Use and Bleeding Risk in Central European Patients with Idiopathic Pulmonary Fibrosis (IPF) Treated with Antifibrotic Therapy: Real-World Data from EMPIRE},
url = {https://link.springer.com/content/pdf/10.1007/s40264-020-00978-5.pdf},
volume = {43},
year = {2020}
}
TY - JOUR
ID - 1674002
AU - Kolonics-Farkas, Abigel M. - Sterclova, Martina - Mogulkoc, Nesrin - Kus, Jan - Hajkova, Marta - Muller, Veronika - Jovanovic, Dragana - Tekavec-Trkanjec, Jasna - Littnerová, Simona - Hejduk, Karel - Vasakova, Martina
PY - 2020
TI - Anticoagulant Use and Bleeding Risk in Central European Patients with Idiopathic Pulmonary Fibrosis (IPF) Treated with Antifibrotic Therapy: Real-World Data from EMPIRE
JF - DRUG SAFETY
VL - 43
IS - 10
SP - 971-980
EP - 971-980
PB - ADIS INT LTD
SN - 01145916
KW - CLINICAL-PRACTICE
KW - PIRFENIDONE
KW - NINTEDANIB
KW - INHIBITOR
KW - DIAGNOSIS
KW - SAFETY
UR - https://link.springer.com/content/pdf/10.1007/s40264-020-00978-5.pdf
L2 - https://link.springer.com/content/pdf/10.1007/s40264-020-00978-5.pdf
N2 - 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).
ER -
KOLONICS-FARKAS, Abigel M., Martina STERCLOVA, Nesrin MOGULKOC, Jan KUS, Marta HAJKOVA, Veronika MULLER, Dragana JOVANOVIC, Jasna TEKAVEC-TRKANJEC, Simona LITTNEROVÁ, Karel HEJDUK and Martina VASAKOVA. Anticoagulant Use and Bleeding Risk in Central European Patients with Idiopathic Pulmonary Fibrosis (IPF) Treated with Antifibrotic Therapy: Real-World Data from EMPIRE. \textit{DRUG SAFETY}. Aucland: ADIS INT LTD, 2020, vol.~43, No~10, p.~971-980. ISSN~0114-5916. Available from: https://dx.doi.org/10.1007/s40264-020-00978-5.
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