SynthesisRespiratory research2015
Safety, tolerability and appropriate use of nintedanib in idiopathic pulmonary fibrosis.
Synthesis in Respiratory research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 87 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)
A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Dose Ranging Study of Oral Epigallocatechin-3-gallate (EGCG) Given Daily for 12 Weeks to Patients With Idiopathic Pulmonary Fibrosis (IPF) Evaluating Safety, PK Interactions With Standard of Care Drugs, and Biomarkers of Drug Effect
Who cites it
87 citing papers in PubMed, 1 synthesis or guideline pooled it, 173 citations in OpenAlex.
- Pooled it
- Continued nintedanib in patients with systemic sclerosis-associated interstitial lung disease: 3-year data from SENSCIS-ON.RMD open · 2025Trial
- Trial
- Risk of Malnutrition in Patients With Systemic Sclerosis-Associated Interstitial Lung Disease Treated With Nintedanib in the Randomized, Placebo-Controlled SENSCIS Trial.Arthritis care & research · 2023Trial
- Effect of nintedanib in patients with progressive pulmonary fibrosis associated with rheumatoid arthritis: data from the INBUILD trial.Clinical rheumatology · 2023Trial
- Weight loss and outcomes in subjects with progressive pulmonary fibrosis: data from the INBUILD trial.Respiratory research · 2023Trial
- Nintedanib in Patients With Autoimmune Disease-Related Progressive Fibrosing Interstitial Lung Diseases: Subgroup Analysis of the INBUILD Trial.Arthritis & rheumatology (Hoboken, N.J.) · 2022Trial
- Safety and tolerability of nintedanib in patients with progressive fibrosing interstitial lung diseases: data from the randomized controlled INBUILD trial.Respiratory research · 2022Trial
- Nintedanib in progressive interstitial lung diseases: data from the whole INBUILD trial.The European respiratory journal · 2022Trial
- Exposure-safety analyses of nintedanib in patients with chronic fibrosing interstitial lung disease.BMC pulmonary medicine · 2021Trial
- Analysis of body mass index, weight loss and progression of idiopathic pulmonary fibrosis.Respiratory research · 2020Trial
- Safety and tolerability of nintedanib in patients with systemic sclerosis-associated interstitial lung disease: data from the SENSCIS trial.Annals of the rheumatic diseases · 2020Trial
- Efficacy and safety of nintedanib in patients with advanced idiopathic pulmonary fibrosis.BMC pulmonary medicine · 2020Trial
- Cardiovascular safety of nintedanib in subgroups by cardiovascular risk at baseline in the TOMORROW and INPULSIS trials.The European respiratory journal · 2019Trial
- Safety of nintedanib added to pirfenidone treatment for idiopathic pulmonary fibrosis.The European respiratory journal · 2018Trial
- Pilot randomized controlled trial of a peer coach-led behavioral and educational intervention to enhance quality of life in patients living with hypersensitivity pneumonitis: Protocol for the RISE-HP study.Contemporary clinical trials communications · 2026Article
- Beyond slowing decline: leveraging apoptotic synergy to reverse pulmonary fibrosis.American journal of respiratory cell and molecular biology · 2026Article
- Nintedanib-Associated Generalized Body Swelling in a Patient With Idiopathic Pulmonary Fibrosis: A Case Report.Cureus · 2026Article
- Continued Nintedanib Treatment in Children and Adolescents With Fibrosing ILDs: Data From InPedILD-ON.Pediatric pulmonology · 2026Article
- Significance of clinical parameters and biomarkers to predict nintedanib-induced diarrhea: an interview-based retrospective study.Journal of thoracic disease · 2025Article
27 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 9 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIdiopathic pulmonary fibrosis (IPF) is a progressive disease characterised by dyspnea and loss of lung function.
methodsUsing pooled data from the replicate, randomized, 52-week, placebo-controlled INPULSIS(®) trials, we characterized the safety and tolerability of nintedanib 150 mg twice daily in patients with IPF and described how adverse events were managed during these trials.
resultsOne thousand and sixty- one patients were treated (nintedanib 638; placebo 423). Higher proportions of patients in the nintedanib group than the placebo group had ≥ 1 dose reduction to 100 mg bid (27.9% versus 3.8%) or treatment interruption (23.7% versus 9.9%). Adverse events led to permanent treatment discontinuation in 19.3% and 13.0% of patients in the nintedanib and placebo groups, respectively. Diarrhea was the most frequent adverse event, reported in 62.4% of patients in the nintedanib group versus 18.4% in the placebo group; however, only 4.4% of nintedanib-treated patients discontinued trial medication prematurely due to diarrhea. Monitoring of liver enzymes before and periodically during nintedanib treatment was recommended so that liver enzyme elevations could be managed through dose reduction or treatment interruption.
conclusionNintedanib had a manageable safety and tolerability profile in patients with IPF. Recommendations for adverse event management minimized permanent treatment discontinuations in the INPULSIS(®) trials.
trial registrationclinicaltrials.gov NCT01335464 and NCT01335477.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.