Serious adverse events in patients with idiopathic pulmonary fibrosis in the placebo arms of 6 clinical trials - 08/04/19
, Danielle Antin-Ozerkis b, J. Terrill Huggins c, Peter P. LaCamera d, Paolo Spagnolo e, Martina Vašáková f, Marlies S. Wijsenbeek g, Boris Polman h, Klaus-Uwe Kirchgaessler i, Mary Beth Scholand jAbstract |
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.
Le texte complet de cet article est disponible en PDF.Highlights |
• | Safety data from 1082 patients who received placebo in 6 IPF trials were analyzed. |
• | A total of 673 SAEs and 93 deaths were reported; 60 deaths were respiratory-related. |
• | The most frequent SAEs were respiratory-, infection-, and cardiac-related. |
• | These placebo data could act as a comparator to treatment arms in future IPF trials. |
Keywords : Idiopathic pulmonary fibrosis, Interstitial lung disease, Safety
Plan
Vol 150
P. 120-125 - avril 2019 Retour au numéro
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