[Comparative study between oral azathioprine and intravenous cyclophosphamide pulses in the treatment of idiopathic pulmonary fibrosis]

Abstract

Introduction: The purpose of the study was to establish the efficacy of treatment with intravenous cyclophosphamide pulses and oral corticoids in idiopathic pulmonary fibrosis, compared with the standard treatment with corticoids and azathioprine.

Patients and method: A prospective, non-controlled study with 2 parallel groups. One group received prednisone plus oral azathioprine for 24 months (AZA group). The second one (CIC group) received prednisone plus intravenous cyclophosphamide pulses (6 monthly and 6 three-monthly). The primary outcome was survival or period without need for a transplant at 36 months. The secondary outcomes were the forced vital capacity, the carbon monoxide diffusing capacity, and baseline arterial oxygen pressure at 3, 6, 12, 18, 24, 30, and 36 months.

Results: A total of 46 patients were included in the study, of whom 25 were assigned to the AZA group and 21 to the CIC group. The survival or absence of lung transplant at 36 months was 44% in the AZA group and 76% in the CIC group (P=0.028). The forced vital capacity was worse in 8.8% of the AZA group compared to 6.7% in the CIC group (P=0.16). The carbon monoxide diffusing capacity worsened in 11.81% of patients of the AZA group and in 4.6% of those in the CIC group (P=0.0569). No significant differences were observed in the arterial oxygen pressure. There was one dropout of treatment with prednisone.

Conclusions: Treatment with intravenous cyclophosphamide pulses produced a significant improvement in survival. There were no significant differences in the lung function parameters or gas exchange. Neither of the cytostatics had serious side effects.