Shotaro Aso1, Hiroki Matsui1, Kiyohide Fushimi2, Hideo Yasunaga1. 1. Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Tokyo, Japan. 2. Department of Health Policy and Informatics, Tokyo Medical and Dental University Graduate School of Medicine, Tokyo, Japan.
Abstract
BACKGROUND: There is currently no recognized treatment for acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF), and the effect of cyclosporine A in patients with AE-IPF remains unknown. METHODS: We identified patients with AE-IPF who received high-dose methylprednisolone plus cyclosporine A or high-dose methylprednisolone alone from July 1, 2010, to March 31, 2014, using the Diagnosis Procedure Combination database in Japan. We compared in-hospital mortality between patients with and without cyclosporine A by multivariable logistic regression analysis, with adjustment for patient and hospital covariates. Unmeasured confounders were accounted for by instrumental variable analysis based on differential distance. RESULTS: Eligible patients (n=7,989) were divided into a high-dose methylprednisolone plus cyclosporine A group (n=384) and a high-dose methylprednisolone alone group (n=7,605). There was no significant difference in terms of in-hospital mortality between the groups according to multivariable logistic regression [odds ratio, 1.27; 95% confidence interval (CI), 0.99-1.64; P=0.06] or instrumental variable analysis (odds ratio, 0.94; 95% CI, 0.12-7.67; P=0.96). CONCLUSIONS: Cyclosporine A did not reduce in-hospital mortality in patients with AE-IPF. Randomised controlled studies are required to confirm this apparent lack of effect of cyclosporine A in AE-IPF.
BACKGROUND: There is currently no recognized treatment for acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF), and the effect of cyclosporine A in patients with AE-IPF remains unknown. METHODS: We identified patients with AE-IPF who received high-dose methylprednisolone plus cyclosporine A or high-dose methylprednisolone alone from July 1, 2010, to March 31, 2014, using the Diagnosis Procedure Combination database in Japan. We compared in-hospital mortality between patients with and without cyclosporine A by multivariable logistic regression analysis, with adjustment for patient and hospital covariates. Unmeasured confounders were accounted for by instrumental variable analysis based on differential distance. RESULTS: Eligible patients (n=7,989) were divided into a high-dose methylprednisolone plus cyclosporine A group (n=384) and a high-dose methylprednisolone alone group (n=7,605). There was no significant difference in terms of in-hospital mortality between the groups according to multivariable logistic regression [odds ratio, 1.27; 95% confidence interval (CI), 0.99-1.64; P=0.06] or instrumental variable analysis (odds ratio, 0.94; 95% CI, 0.12-7.67; P=0.96). CONCLUSIONS: Cyclosporine A did not reduce in-hospital mortality in patients with AE-IPF. Randomised controlled studies are required to confirm this apparent lack of effect of cyclosporine A in AE-IPF.