COLCHICINE, D-PENICILLAMINE, AND PREDNISONE IN THE TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS - A CONTROLLED CLINICAL-TRIAL

Study objective: We compared the long-term efficacy of the combination of colchicine and/or D-penicillamine with prednisone, in comparison t o prednisone alone in patients with idiopathic pulmonary fibrosis (IPF ), Design: Nonrandomized prospective study in patients with IPF confir med by biopsy specimen. Setting: National Institute of Respiratory Dis eases, Mexico. Patients: Fifty-six IPF patients were included in this study. Patients received either colchicine/ prednisone (n=19), D-penic illamine/prednisone (n=11), D-penicillamine/colchicine/prednisone (n=1 1), or prednisone alone (n=15), Prednisone therapy was started at 1.0 mg/kg/d for 1 month followed by a biweekly taper to a maintenance dose of 15 mg/d, Colchicine was administered at a daily dose of 1.0 mg, an d D-penicillamine was given at a daily dose of 600 mg, Measurements an d results: Response to therapy was assessed by changes in lung functio n test results as measured by total and vital lung capacities, arteria l blood gas analysis at rest breathing room air, and survival. No sign ificant differences either in lung mechanics or in arterial gases were found in any group relative to the baseline measurement. Thirteen of the 56 patients died during the first 2 years, and 29 were dead at 5 y ears follow-up. Comparison of survival curves by Cox regression model showed no statistically significant difference among the four groups. Known side effects attributable to prednisone were more common and sev ere than those attributable to the other drugs. Conclusions: Our resul ts suggest that neither colchicine nor D-penicillamine modified the pr ogressive course of prednisone-treated IPF, and that the search for ne w drugs is imperative.