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. Incidence rates of other ischaemic heart disease in the nintedanib and placebo groups, respectively, were 1.85 (95% CI:1.02–3.34) and 3.28 (95% CI:1.94–5.54) per 100 patient-years in patients with higher CV risk and 0 and 1.80 (95% CI:0.25–12.78) per 100 patient-years in patients with lower CV risk.
These data help to establish the CV safety profile of nintedanib in IPF.
Footnotes
This manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.
Conflict of interest: Dr. Noth reports personal fees and other from Boehringer Ingelheim, personal fees and other from HLR/Genentech, personal fees from Sanofi Aventis, personal fees from Global blood therapeutics, personal fees from Veracyte, outside the submitted work.
Conflict of interest: Dr. Wijsenbeek reports grants and other from Boehringer Ingelheim, grants and other from Hoffman la Roche , other from galapagos, outside the submitted work.
Conflict of interest: Dr. Kolb reports grants from Canadian Pulmonary Fibrosis Foundation, other from Roche, other from Sanofi, other from Boehringer Ingelheim, grants from Canadian Institute for Health Research, grants and other from Pulmonary Fibrosis Foundation, personal fees from Boehringer Ingelheim, grants and personal fees from Roche Canada, personal fees from GlaxoSmithKline, personal fees from AstraZeneca, personal fees from Vertex, personal fees from Genoa, personal fees from Gilead, grants and personal fees from Janssen, personal fees from Prometic, personal fees from Alkermes, outside the submitted work.
Conflict of interest: Dr. Bonella reports personal fees and non-financial support from Boehringer Ingelheim, personal fees and non-financial support from Roche Pharma, outside the submitted work.
Conflict of interest: Dr. Moros is an employee of Boehringer Ingelheim
Conflict of interest: Dr. Wachtlin is an employee of Boehringer Ingelheim
Conflict of interest: Dr. Corte reports grants and personal fees from Boehringer Ingleheim, grants and personal fees from Roche, grants from Gilead, grants from Bayer, grants from Intermune, personal fees from AstraZeneca, grants from BMS, during the conduct of the study.
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