Preliminary trial results show triple-drug regimen may be harmful for idiopathic pulmonary fibrosis

Therapy with a combination of prednisone, azathioprine and N-acetylcysteine may be harmful in patients with idiopathic pulmonary fibrosis, the National Institutes of Health announced last week.

The NIH was conducting a three-arm multicenter clinical trial to evaluate treatments for idiopathic pulmonary fibrosis and found that outcomes were worse in patients receiving the triple-drug regimen than in those receiving placebo. Compared with the placebo group, the triple-drug group had higher rates of mortality (11% vs. 1%), hospitalization (29% vs. 8%) and adverse events (31% vs. 9%). Adherence rates were also lower in the triple-drug group than in the placebo group (78% vs. 98%), while tests of lung function did not differ.

Based on these results, the Data Safety and Monitoring Board recommended that the triple-therapy arm of the trial be stopped, and the NIH has complied. The arms of the trial in which patients receive either N-acetylcysteine alone or placebo will continue, the NIH said.

It is very important to note that these are only preliminary reports and that firm conclusions must await peer-reviewed data. The study co-chair cautioned that patients currently taking these medications should consult with their physicians before stopping therapy. More information is available online.