Azathioprine combined with prednisone in the treatment of idiopathic pulmonary fibrosis: a prospective double-blind, randomized, placebo-controlled clinical trial
| Autor: | Kevin C. Cain, Neeley E. Pardee, John F. Hutchinson, Richard H. Winterbauer, Claude E. Wetzel, David F. Dreis, Samuel P. Hammar, Ganesh Raghu, William J. Depaso |
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| Rok vydání: | 1991 |
| Předmět: |
Pulmonary and Respiratory Medicine
Male medicine.medical_specialty Time Factors medicine.drug_class Pulmonary Fibrosis Azathioprine Placebo Gastroenterology Idiopathic pulmonary fibrosis Double-Blind Method Prednisone Internal medicine medicine Humans Prospective Studies Proportional Hazards Models Maintenance dose business.industry Therapeutic effect Hazard ratio Middle Aged medicine.disease Survival Analysis Surgery Corticosteroid Drug Therapy Combination Female business medicine.drug |
| Zdroj: | The American review of respiratory disease. 144(2) |
| ISSN: | 0003-0805 |
| Popis: | Twenty-seven newly diagnosed patients with idiopathic pulmonary fibrosis (IPF) who were previously untreated for IPF were enrolled in a prospective, double-blind, randomized, placebo-controlled study to compare the therapeutic effect of combined prednisone/azathioprine (n = 14) with prednisone plus placebo (n = 13). Prednisone was started at 1.5 mg/kg/day (not to exceed 100 mg/day) for the first 2 wk followed by a biweekly taper to a maintenance dose of 20 mg/day. Azathioprine was administered at a daily dose of 3 mg/kg (not to exceed 200 mg/day). The patients tolerated the use of azathioprine well with few associated side effects. Changes in lung function at 1 yr, as measured by resting alveolar-arterial oxygen difference P[A-a]O2, FVC, and single breath diffusing capacity for carbon monoxide (DLCOSB), were all somewhat better in the azathioprine/prednisone group compared with the prednisone alone group, although none of these comparisons were statistically significant. Six of 14 (43%) patients randomized to prednisone plus azathioprine died during the 9-yr follow-up period, compared with 10 of 13 (77%) patients randomized to prednisone plus placebo. A Cox model survival analysis shows a nonsignificant but potentially large survival advantage for azathioprine/prednisone (hazard ratio 0.48, with 95% confidence interval increasing from 0.17 to 1.38). When adjusted for age, the survival advantage of azathioprine/prednisone becomes marginally significant (hazard ratio 0.26, with 95% confidence interval increasing from 0.08 to 0.88; p = 0.02 by large sample approximation, p = 0.05 by randomization test). We conclude that combined prednisone and azathioprine is a safe and possibly effective regimen for the treatment of IPF.(ABSTRACT TRUNCATED AT 250 WORDS) |
| Databáze: | OpenAIRE |
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