Serious adverse events in patients with idiopathic pulmonary fibrosis in the placebo arms of 6 clinical trials
Language English Country Great Britain, England Media print-electronic
Document type Clinical Trial, Phase II, Clinical Trial, Phase III, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
PubMed
30961937
DOI
10.1016/j.rmed.2019.02.021
PII: S0954-6111(19)30075-7
Knihovny.cz E-resources
- Keywords
- Idiopathic pulmonary fibrosis, Interstitial lung disease, Safety,
- MeSH
- Safety statistics & numerical data MeSH
- Idiopathic Pulmonary Fibrosis drug therapy epidemiology mortality physiopathology MeSH
- Myocardial Infarction epidemiology MeSH
- Infections epidemiology MeSH
- Lung Diseases, Interstitial epidemiology mortality MeSH
- Comorbidity MeSH
- Middle Aged MeSH
- Humans MeSH
- Heart Diseases epidemiology MeSH
- Placebos administration & dosage adverse effects MeSH
- Pneumonia epidemiology MeSH
- Disease Progression MeSH
- Respiratory Function Tests methods MeSH
- Respiratory Insufficiency epidemiology MeSH
- Aged MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase II MeSH
- Clinical Trial, Phase III MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
- Names of Substances
- Placebos MeSH
BACKGROUND: Idiopathic pulmonary fibrosis (IPF) is a fatal interstitial lung disease characterized by irreversible loss of lung function and an unpredictable course of disease progression. METHODS: The safety data for patients with IPF who received placebo in 6 clinical trials were pooled to examine the categories and frequencies of serious adverse events (SAEs) in this population. RESULTS: In 1082 patients with IPF who received placebo, 673 SAEs were reported. Of these, 93 SAEs resulted in death (8.6% of patients). Respiratory-related conditions were the most frequently reported SAE (225 events, 16.33 per 100 patient-exposure years [PEY]), followed by infections and infestations (136 events, 9.87 per 100 PEY) and cardiac disorders (79 events, 5.73 per 100 PEY); these categories also had the most fatal outcomes (60, 10, and 10 deaths, respectively). The most frequently reported fatal respiratory-related SAEs were IPF and respiratory failure (38 and 11 patients, respectively), and the most frequently reported fatal infections and infestations and cardiac disorders were pneumonia (5 patients) and myocardial infarction (3 patients), respectively. CONCLUSIONS: This pooled analysis has value as a comparator for safety in future studies of IPF and provides insights in the natural evolution of both IPF and common comorbidities.
1st Medical Faculty Charles University and Thomayer Hospital Prague Czech Republic
Department of Respiratory Medicine Erasmus MC University Medical Center Rotterdam the Netherlands
F Hoffmann La Roche Ltd Basel Switzerland
Genentech Inc South San Francisco CA USA
Medical University of South Carolina Charleston SC USA
St Elizabeth's Medical Center Boston MA USA
University Hospitals Leuven Leuven Belgium
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