Kolb M, et al. - Researchers performed this study to test the safety as well as the efficacy of nintedanib plus sildenafil, as compared with nintedanib alone, as treatment in patients with idiopathic pulmonary fibrosis (IPF) and a diffusion capacity of the lungs for carbon monoxide (DL_CO) that was 35% or less of the predicted value and to enlarge the database for nintedanib monotherapy with data from patients with IPF and severely impaired gas exchange. It was concluded that nintedanib plus sildenafil did not give a significant benefit vs nintedanib alone in patients with IPF and a DL_CO of 35% or less of the predicted value. In this population of patients, no new safety signals were identified with either treatment regimen.

Methods

• For this investigation, researchers randomly assigned, in a 1:1 ratio, subjects with IPF and a DL_CO of 35% or less of the predicted value to receive nintedanib at a dose of 150 mg twice daily plus sildenafil at a dose of 20 mg three times daily (nintedanib-plus-sildenafil group) or nintedanib at a dose of 150 mg twice daily plus placebo three times daily (nintedanib group) for 24 weeks.
• The change from baseline in the total score on the St. George’s Respiratory Questionnaire (SGRQ) at week 12 (the total score ranges from 0 to 100, with higher scores indicating worse health-related quality of life) was the primary end point.
• Measures of dyspnea and safety were the included secondary end points.

Results

• An aggregate of 274 subjects had randomization.
• No significant difference was found in the adjusted mean change from baseline in the SGRQ total score at week 12 between the nintedanib-plus-sildenafil group and the nintedanib group (-1.28 points 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, a benefit from sildenafil treatment was not seen.
• As compared with previous trials, no new safety signals were observed.