Two drugs to reduce the scarring of the lungs that occurs in patients with idiopathic pulmonary fibrosis (IPF) appear to increase longevity and decrease hospitalizations, according to new research published online in the American Journal of Respiratory and Critical Care Medicine.
In “Clinical Effectiveness of the Anti-Fibrotic Medications for Idiopathic Pulmonary Fibrosis,” lead author Timothy M. Dempsey, MD, and co-authors report on a retrospective study of pirfenidone and nintedanib, which became the first and only drugs approved by the Food and Drug Administration for IPF in 2014. At the time, randomized controlled trials demonstrated that both medications slowed the decline of lung function, but the trials did not prove that the drugs helped patients live longer because the number of participants in the trials was too small to make that determination.
“We sought to use a large insurance database to evaluate the effectiveness of these drugs in larger numbers of individuals,” said senior author Andrew H. Limper, MD, Robert D. and Patricia E. Kern Associate Dean of Practice Transformation and the Walter and Leonore Annenberg Professor of Pulmonary Medicine at Mayo Clinic, in Rochester, Minn. “The database provides ‘real-world’ evidence of the effectiveness of these drugs in clinical practice, complementing the information learned through randomized controlled trials.”
Using OptumLabs Data Warehouse, the researchers matched 1,255 patients diagnosed with IPF and on pirfenidone or nintedanib with 1,255 IPF patients not taking either drug. The database includes medical claims information for commercially insured and Medicare Advantage patients across the country.
The study found:
- Patients on either of the drugs were 23 percent less likely to die from any cause throughout the first two years of treatment. After that, the survival benefit of the drugs disappeared.
- Patients on either of the drugs were 30 percent less likely to be hospitalized for any cause.
- There was no difference between the two drugs in their ability to reduce deaths from all causes.
- The study was not designed to discover why the survival benefit of the two drugs declined over time.
- However, the researchers said that the finding may suggest that doctors should prescribe one drug for a period of time and then switch to the other in the hope of extending the clinical benefits of the drugs.
The authors noted that the patients in their study were older and sicker than the patients who participated in the randomized controlled trials that the FDA considered when approving the two drugs. This fact, they said, indicates that both drugs may not only help those with mild or moderate disease, but may also benefit those with severe IPF.
Because the current study was not a randomized, controlled trial it cannot prove cause and effect, and the researchers noted that because patients in the study had private insurance or were enrolled in Medicare Advantage, the findings may not be generalizable to all patients.
Still, Dr. Limper said, “our study further suggests that patients with IPF, even with severe disease, receive benefit from using the anti-fibrotic medications pirfenidone and nintedanib, and that these drugs may reduce mortality in this progressive and serious illness.”