Safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis in Brazil.

ABSTRACT:

Objective

Clinical trials have shown that nintedanib 150 mg twice daily (bid) reduces disease progression in patients with idiopathic pulmonary fibrosis (IPF), with an adverse event profile that is manageable for most patients. Prior to the approval of nintedanib as a treatment for IPF in Brazil, an expanded access program (EAP) was initiated to provide early access to treatment and to evaluate the safety and tolerability of nintedanib in this patient population.

Methods

Patients with a diagnosis of IPF within the previous five years, forced vital capacity (FVC) ≥ 50% predicted and diffusing capacity of the lungs for carbon monoxide (DLco) 30% to 79% predicted were eligible to participate in the EAP. Patients received nintedanib 150 mg bid open-label. Safety assessments incl

SUBMITTER: Pereira CAC 

PROVIDER: S-EPMC8653976 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature