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Eur Respir J. 2017 May 19;49(5). pii: 1601339. doi: 10.1183/13993003.01339-2016. Print 2017 May.

Acute exacerbations in the INPULSIS trials of nintedanib in idiopathic pulmonary fibrosis.

Author information

1
Division of Pulmonary and Critical Care Medicine, Dept of Medicine, University of California San Francisco, San Francisco, CA, USA Hal.Collard@ucsf.edu.
2
National Institute for Health Research Southampton Respiratory Biomedical Research Unit and Clinical and Experimental Sciences, University of Southampton, Southampton, UK.
3
Division of Respiratory Medicine, Università Cattolica del Sacro Cuore, Fondazione Policlinico "A. Gemelli", Rome, Italy.
4
Asan Medical Center, University of Ulsan, Seoul, South Korea.
5
Dept of Respiratory Medicine and Allergy, Tosei General Hospital, Aichi, Japan.
6
PRA Health Sciences, Paris, France.
7
University of Pavia, Pavia, Italy.
8
University of Louisville School of Medicine and Robley Rex VA Medical Center, Louisville, KY, USA.
9
Penn Presbyterian Medical Center, Dept of Medicine, Philadelphia, PA, USA.
10
Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.
11
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.
12
Imperial College, London, UK.

Abstract

Time to first investigator-reported acute exacerbation was a key secondary end-point in the INPULSIS trials of nintedanib in patients with idiopathic pulmonary fibrosis (IPF).We used the INPULSIS trial data to investigate risk factors for acute exacerbation of IPF and to explore the impact of nintedanib on risk and outcome of investigator-reported and adjudicated confirmed/suspected acute exacerbations. Mortality following these events and events adjudicated as not acute exacerbations was analysed using the log rank test.Risk of acute exacerbations was most strongly associated with the following variables: baseline forced vital capacity (higher risk with lower value), baseline supplemental oxygen (higher risk with use), baseline antacid medication (higher risk with use), treatment (higher risk with placebo), and for confirmed/suspected acute exacerbations, cigarette smoking. Mortality was similar following investigator-reported and adjudicated confirmed/suspected acute exacerbations. Nintedanib had no significant effect on risk of mortality post-exacerbation.Investigator-reported acute exacerbations of IPF are associated with similar risk factors and outcomes as adjudicated confirmed/suspected acute exacerbations.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01335464 NCT01335477.

PMID:
28526798
DOI:
10.1183/13993003.01339-2016
[Indexed for MEDLINE]

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