Results of a recently published study indicate that the three-drug regimen of prednisone, azathioprine, and N-acetylcysteine may prove to be more harmful than beneficial in patients with idiopathic pulmonary fibrosis.
Idiopathic pulmonary fibrosis is a condition where the lungs are damaged and replaced by scar tissue, which impedes adequate air exchange. Lung transplantation is done for some cases.
AdvertisementMild cases are treated either with a single drug, two-drug regimen or three-drug regimen. Many patients are treated with the three-drug regimen, despite absence of clear-cut benefits of the same.
A study compared the use of three drugs prednisone, azathioprine, and N-acetylcysteine in patients with mild-to-moderate pulmonary fibrosis, with the use of either a single drug N-acetylcysteine or placebo. The researchers reported the results of one part of the study, comparison of three-drug use with that of placebo in a paper published in the New England Journal of Medicine.
The analysis was carried out on data obtained from 77 patients on the combination therapy and 78 patients on placebo. The number of patients who discontinued the three drugs by the 60th week was much more than the number of patients who discontinued placebo.
The patients were checked at baseline, and at 4, 15, 30, 45, and 60 weeks of treatment. During the study, it was found that patients on the three-drug regimen had more number of deaths (8 vs. 1), hospitalizations (23 vs. 7) and serious adverse effects (24 vs. 8) as compared to the placebo group. In addition, the three-drug regimen did not appear to provide much benefit as compared to placebo. Hence, it was decided to discontinue the regimen in this group.
The study does have some limitations. For instance, the treatment duration with three drugs may have been too short to register any benefits. The exact cause of deaths and hospitalizations were not recorded; in some cases, hospitalizations may have been for an unrelated cause.
The authors thus suggest that it may currently not be advisable to use the three-drug regimen for the treatment of idiopathic pulmonary fibrosis.
Prednisone, Azathioprine, and N-Acetylcysteine for Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis Clinical Research Network; N Engl J Med 2012; 366:1968-1977.
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