Nintedanib Plus Sildenafil No Better Than Nintedanib in IPF
No benefit with sildenafil in idiopathic pulmonary fibrosis with severe impairment in gas exchange
FRIDAY, Sept. 28, 2018 (HealthDay News) -- Nintedanib plus sildenafil does not provide benefit over nintedanib alone for patients with idiopathic pulmonary fibrosis (IPF) and diffusion capacity of the lungs for carbon monoxide (DLCO) of 35 percent or less of the predicted value, according to a study published online Sept. 15 in the New England Journal of Medicine. The research was published to coincide with the European Respiratory Society International Congress 2018, held from Sept. 15 to 19 in Paris.
Martin Kolb, M.D., from McMaster University and St. Joseph's Healthcare in Hamilton, Canada, and colleagues randomized 274 patients with IPF and a DLCO of 35 percent or less of the predicted value to receive nintedanib plus sildenafil or nintedanib plus placebo for 24 weeks. The change from baseline in total score on the St. George's Respiratory Questionnaire (SGRQ) at week 12 was the primary end point.
The researchers found that there was no significant difference between the nintedanib-plus-sildenafil group and the nintedanib group in terms of the adjusted mean change from baseline in the SGRQ total score at week 12 (−1.28 and −0.77 points, respectively; P = 0.72). With regard to dyspnea as measured with the use of the University of California, San Diego, Shortness of Breath Questionnaire, there was no benefit from sildenafil treatment. Compared with previous trials, there were no new safety signals observed.
"Combination therapy with nintedanib plus sildenafil did not provide a significant benefit as compared with nintedanib monotherapy in patients with IPF and severe impairment in gas exchange," the authors write.
Several authors disclosed financial ties to biopharmaceutical and medical device companies, including Boehringer Ingelheim, which funded the study.