Real-World Data on Bleeding Risk and Anticoagulation in Patients with IPF Treated with Antifibrotics
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COMMENTARY
Real‑World Data on Bleeding Risk and Anticoagulation in Patients with IPF Treated with Antifibrotics Elisabeth Bendstrup1 · Meena Kalluri2
© Springer Nature Switzerland AG 2020
Idiopathic pulmonary fibrosis (IPF) is a scarring lung disease of unknown cause characterized by irreversible, relentless, and progressive loss of lung function and with limited treatment options. The median survival is 2–3 years [1]. Lung transplantation can prolong life but is only offered to a minority of patients [2]. Several agents have been investigated in randomized controlled trials (RCTs) in recent years, but only two antifibrotic agents—nintedanib and pirfenidone—have been approved. Both agents slow disease progression, prolong time to acute exacerbations in IPF, and might improve survival [3, 4]. Multiple trials have failed in IPF, mostly because of futility, but a minority of trials was also interrupted because of a negative impact on mortality and morbidity [5]. Among these is the ACE-IPF study, a placebo-controlled randomized study of warfarin in IPF [6]. In this study, compared with patients receiving placebo, those randomized to warfarin for the treatment of IPF experienced a lack of therapeutic effects coupled with higher rates of allcause death and all-cause hospitalizations. This alarming finding was further supported in observational real-life studies with medically indicated anticoagulant therapy [7–9], which has resulted in scientific debate over the best anticoagulant agent in patients with IPF. Some argue against the use of vitamin K antagonists for medically indicated reasons such as acute pulmonary embolism because of the detrimental outcomes in the ACE-IPF study, whereas others find the current evidence indirect and recommend that patients with IPF and alternative indications for anticoagulation be treated This comment refers to the article available at https://doi. org/10.1007/s40264-020-00978-5. * Elisabeth Bendstrup [email protected] 1
Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus, Denmark
Division of Pulmonary Medicine, Department of Medicine, University of Alberta, Alberta Health Services, Edmonton, AB, Canada
2
according to best practice [10, 11]. Based on in vitro studies, new anticoagulants seem to have potential antifibrotic properties without the negative effects of vitamin K antagonists [12]. So far, international guidelines only contain recommendations against the use of warfarin for the treatment of IPF and leave the other questions unanswered [1]. RCTs, including the previous trials with antifibrotic agents, have strict inclusion and exclusion criteria, and trials often exclude patients with significant comorbidities [3, 4]. Three previous trials—the TOMORROW trial and the two INPULSIS trials—studied nintedanib, a tyrosine kinase inhibitor (TKI), in patients with mild to moderate IPF [4, 13]. Nintedanib has antifibrotic, anti-inflammatory, and antiangiogenic activity, elicited by potentially inhibiting vascular endothelial growth factor re
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