CV safety of nintedanib in subgroups by CV risk at baseline in the TOMORROW and INPULSIS trials.

CV safety of nintedanib in subgroups by CV risk at baseline in the TOMORROW and INPULSIS trials. Eur Respir J. 2019 Jul 08;: Authors: Noth I, Wijsenbeek M, Kolb M, Bonella F, Moros L, Wachtlin D, Corte TJ Abstract Nintedanib is a tyrosine kinase inhibitor used to treat idiopathic pulmonary fibrosis (IPF). We investigated the cardiovascular (CV) safety of nintedanib using pooled data from the TOMORROW and INPULSIS® trials.CV events were assessed post-hoc in patients with a history of atherosclerotic CV disease (CVD) and/or ≥1 CV risk factor at baseline ("higher CV risk") and patients with no history of atherosclerotic CVD and no CV risk factors at baseline ("lower CV risk").Incidence rates were calculated for 1231 patients (723 nintedanib, 508 placebo), of whom 89.9% had higher CV risk. Incidence rates of major adverse cardiovascular events were similar in the nintedanib and placebo groups in patients with higher CV risk (3.88 [95% CI:2.58-5.84] and 3.49 [95% CI:2.10-5.79] per 100 patient-years, respectively) and lower CV risk (4.78 [95% CI: 1.54, 14.82] and 5.37 [95% CI: 1.73, 16.65] per 100 patient-years, respectively). Incidence rates of myocardial infarction in the nintedanib and placebo groups, respectively, were 3.03 (95% CI:1.91-4.81) and 1.16 (95% CI:0.48-2.79) per 100 patient-years in patients with higher CV risk and 1.59 (95% CI:0.22-11.29) and 1.78 (95% CI:0.25-12.64) per 100 patient-years in patients with lower CV risk....
Source: Respiratory Care - Category: Respiratory Medicine Authors: Tags: Eur Respir J Source Type: research