Bleeding events in IPF patients treated with antifibrotics

Objective of the EMPIRE-based study was to examine real-world bleeding events in patients with IPF treated with antifibrotics, including those receiving anticoagulants and/or antiplatelet therapy.

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).

The study shows that the incidence of bleeding was low in patients treated with antifibrotics in a real-world setting. Of the 2,794 patients included in the study, bleeding was reported in one patient who received pirfenidone, and in seven patients with IPF who received nintedanib, with five of these bleeding events recorded in patients who received nintedanib without anticoagulant and antiplatelet treatment. The very low number of non-severe bleeding events provides reassurance on the safety concerns of nintedanib in anticoagulant- and/or antiplatelet-treated patients with IPF in a real-world setting.

Citation: Kolonics-Farkas A, Šterclová M, Mogulkoc N, Kus J, Hájková M, Müller V, Jovanovic D, Tekavec-Trkanjec J, Littnerová S, Hejduk K, Vašáková M. 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 2020.

4. 8. 2020