Observational studyRespiratory investigation2015
All-case post-marketing surveillance of 1371 patients treated with pirfenidone for idiopathic pulmonary fibrosis.
Observational study in Respiratory investigation, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 1 of them a synthesis that pooled it.
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
40 citing papers in PubMed, 1 synthesis or guideline pooled it, 77 citations in OpenAlex.
- Real-world safety and effectiveness of pirfenidone and nintedanib in the treatment of idiopathic pulmonary fibrosis: a systematic review and meta-analysis.European journal of clinical pharmacology · 2024Pooled it
- A Phase 2 Study of Atezolizumab for Pretreated NSCLC With Idiopathic Interstitial Pneumonitis.Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2020Trial
- Adverse side-effects of antifibrotic drugs and outcome of treatment in idiopathic pulmonary fibrosis.Journal of thoracic disease · 2025Article
- High incidence of immune checkpoint inhibitor-induced pneumonitis in patients with non-small cell lung cancer and interstitial pneumonia, regardless of honeycomb lung or forced vital capacity: results from a multicenter retrospective study.International journal of clinical oncology · 2025Article
- Real-World Experience in the Clinical Use of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis in Taiwan: A Post-Marketing Surveillance Study.Biomedicines · 2024Article
- Risk of potential hepatotoxicity from pirfenidone or nintedanib in patients with idiopathic pulmonary fibrosis: results of a retrospective analysis of a large insurance database in Taiwan.Frontiers in pharmacology · 2024Article
- Safety, effectiveness, and usefulness of higher-dose tablets of generic pirfenidone in patients with IPF: a nationwide observational study in South Korea.Frontiers in pharmacology · 2024Article
- Effects of comorbid chronic kidney disease on mortality in idiopathic pulmonary fibrosis patients and influence of pirfenidone.Scientific reports · 2023Article
- Efficacy of Pirfenidone According to Dose in Patients with Idiopathic Pulmonary Fibrosis: A Prospective, Observational, Single-Center Cohort Study.Life (Basel, Switzerland) · 2023Article
- Multicenter Population Pharmacokinetics and Exposure-Efficacy Analysis of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis.Clinical pharmacokinetics · 2023Article
- Use of a pulmosphere model to evaluate drug antifibrotic responses in interstitial lung diseases.Respiratory research · 2023Article
- Article
- Real world experience on the effectiveness and safety of pirfenidone in patients with idiopathic pulmonary fibrosis in Taiwan.Frontiers in medicine · 2023Article
- Analysis of real-world data and a mouse model indicates that pirfenidone causes pellagra.ERJ open research · 2022Article
- Exophilone, a Tetrahydrocarbazol-1-one Analogue with Anti-Pulmonary Fibrosis Activity from the Deep-Sea FungusMarine drugs · 2022Article
- Article
- Clinical outcomes of dose modification during pirfenidone treatment for IPF: A nationwide post-marketing surveillance study.Frontiers in pharmacology · 2022Article
- Cardiac Fibrosis in the Pressure Overloaded Left and Right Ventricle as a Therapeutic Target.Frontiers in cardiovascular medicine · 2022Review
- Evaluation of efficacy and safety of pirfenidone 200 mg tablets in patients with idiopathic pulmonary fibrosis in a real-life settingTurkish journal of medical sciences · 2021Article
- Treatment of electronic cigarette or vaping product use-associated lung injury (EVALI) by corticosteroid and low-dose pirfenidone: Report of a case.Respirology case reports · 2021Article
Corrections and comments
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Authors and funding
12 authors at 9 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIdiopathic pulmonary fibrosis (IPF) is a chronic fibrotic lung disease with a median survival of 2-5 years and limited treatment options. In 2008, pirfenidone became the first drug to be approved for IPF treatment in Japan. The aim of this study was to assess the safety of pirfenidone for IPF treatment in a clinical setting.
methodsWe conducted a safety-oriented post-marketing surveillance of all patients with IPF who were administered pirfenidone in the first year after its launch in Japan. This was a prospective, non-interventional, observational study. Case report forms were used to collect survey data, comprising adverse events, acute exacerbations, patient demographics, concomitant drug use, and concurrent treatment data.
resultsOf the 1371 patients available for safety evaluation, two-thirds had stage III-IV disease. The incidence of total adverse drug reactions (ADRs) was 64.6%. ADRs with an incidence of ≥3% were decreased appetite, photosensitivity reaction, nausea, abdominal discomfort, malaise, somnolence, and hepatic function abnormal. This safety profile was consistent with the findings in phase II and III trials in Japan. The discontinuation rates due to adverse events at 12 months for each disease stage were similar; however, discontinuation caused by disease progression increased with disease severity. Treatment with pirfenidone stabilized both vital capacity and subjective symptoms in most patients (70-80%) treated for at least 6 months.
conclusionsThis post-marketing surveillance in Japan showed that pirfenidone was generally well tolerated in patients with IPF, including those with severe lung function impairment.
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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.