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

J 2020

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

KOLONICS-FARKAS, Abigel M., Martina STERCLOVA, Nesrin MOGULKOC, Jan KUS, Marta HAJKOVA et. al.

Basic information

Original name

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

Authors

KOLONICS-FARKAS, Abigel M. (348 Hungary, guarantor), Martina STERCLOVA (203 Czech Republic), Nesrin MOGULKOC (792 Turkey), Jan KUS (616 Poland), Marta HAJKOVA (703 Slovakia), Veronika MULLER (348 Hungary), Dragana JOVANOVIC (688 Serbia), Jasna TEKAVEC-TRKANJEC (191 Croatia), Simona LITTNEROVÁ (203 Czech Republic, belonging to the institution), Karel HEJDUK (203 Czech Republic, belonging to the institution) and Martina VASAKOVA (203 Czech Republic)

Edition

DRUG SAFETY, Aucland, ADIS INT LTD, 2020, 0114-5916

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30304 Public and environmental health

Country of publisher

New Zealand

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 5.606

RIV identification code

RIV/00216224:14110/20:00116194

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1007/s40264-020-00978-5

UT WoS

000554054500001

Keywords in English

CLINICAL-PRACTICE; PIRFENIDONE; NINTEDANIB; INHIBITOR; DIAGNOSIS; SAFETY

Abstract

V originále

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).

Citovat

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. 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.

@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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