Parametric Time-to-Event Model for Acute Exacerbations in Idiopathic Pulmonary Fibrosis
Autor: | Fei Tang, Julia Korell, Susanne Stowasser, Benjamin Weber |
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Rok vydání: | 2019 |
Předmět: |
Male
medicine.medical_specialty Vital capacity Indoles Time Factors Exacerbation Vital Capacity Article FEV1/FVC ratio chemistry.chemical_compound Idiopathic pulmonary fibrosis Internal medicine Covariate Medicine Humans Pharmacology (medical) Protein Kinase Inhibitors Survival analysis Aged Randomized Controlled Trials as Topic Univariate analysis Models Statistical business.industry Research lcsh:RM1-950 Age Factors Articles Middle Aged medicine.disease Idiopathic Pulmonary Fibrosis Oxygen lcsh:Therapeutics. Pharmacology chemistry Clinical Trials Phase III as Topic Modeling and Simulation Cardiology Nintedanib Female business |
Zdroj: | CPT: Pharmacometrics & Systems Pharmacology CPT: Pharmacometrics & Systems Pharmacology, Vol 9, Iss 2, Pp 87-95 (2020) |
ISSN: | 2163-8306 |
Popis: | We describe a parametric time‐to‐event model for idiopathic pulmonary fibrosis (IPF) exacerbations and identify predictors of exacerbation risk using data obtained for the tyrosine‐kinase inhibitor nintedanib in two phase III studies (INPULSIS‐1/2). Parametric survival analysis was performed on time to first exacerbation (censoring on day 372), with univariate analysis to select statistically significant covariates (P = 0.05). Multivariate covariate models were developed using stepwise covariate modeling with forward inclusion (P = 0.05) and backward elimination (P = 0.01). Sixty‐three first exacerbation events were reported across 1,061 subjects in the INPULSIS studies. Baseline and decline of forced vital capacity (FVC)/percent‐predicted FVC (%pFVC), supplemental oxygen use, baseline CO diffusing capacity and age were statistically significant in the univariate analysis. The final covariate model included decline in FVC to week 52, baseline %pFVC, supplemental oxygen use, and age. The developed model may be used to identify patients at high risk of IPF exacerbations and accelerate development of novel treatments. |
Databáze: | OpenAIRE |
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