Esbriet and Ofev Improve Pulmonary Fibrosis Lung Function, but Not N-acetylcysteine, Study Suggests

Using Esbriet (pirfenidone) or Ofev (nintedanib) for a year reduces lung function decline in idiopathic pulmonary fibrosis (IPF) patients, according to a review of nine clinical trials.

Esbriet may also improve patients’ survival. But N-acetylcysteine failed to improve lung function or decrease mortality, the comparative study indicated.

The article, “Systematic Review and Network Meta-analysis of Idiopathic Pulmonary Fibrosis Treatments,” was published in the Journal of Managed Care & Specialty Pharmacy.

Esbriet and Ofev are two of the recommended treatments for IPF. The European Medicines Agency approved Esbriet in 2011 and Ofev in 2015. The U.S. Food and Drug Administration approved both in 2014.

Some doctors prescribe N-acetylcysteine, particularly for symptom relief, although regulatory agencies have yet to approve it.

Until now, “no head-to-head trials have been conducted to directly compare the efficacy of these therapies in IPF,” the researchers noted. They decided to compare the effectiveness of approved and non-approved treatments in adults with IPF. They reviewed, and did a network meta-analysis (NMA) of, Phase 2 and 3 randomized controlled trials in adults.

The team focused on forced vital capacity, or FVC — a measure of lung function — and mortality among patients who took Esbriet, Ofev, or N-acetylcysteine.

Their analysis, which included nine studies, showed that taking Esbriet or OFEV reduced decline in lung function after one year — a significant result. N-acetylcysteine had no effect on lung function, as measured by FVC, relative to placebo, the analysis showed.

Esbriet also reduced the rate of all-cause mortality over the same period, compared with controls. The same effect was not observed with Ofev or N-acetylcysteine.

Researchers cautioned, however, that “the relevant studies conducted to date have not been powered to identify any difference in mortality rates.” That means studies are needed to address the drugs’ impact on mortality, the researchers said.

Overall, the analysis “indicates that pirfenidone and nintedanib are effective treatments for IPF, with both treatments reducing the decline in lung function over a year compared with placebo. N-acetylcysteine was found to be no more effective than placebo.” the team concluded.