Nintedanib linked to lower rate of decline in forced vital capacity versus placebo in phase 3 trial
MONDAY, Sept. 30, 2019 (HealthDay News) — For patients with progressive fibrosing interstitial lung diseases, nintedanib is associated with a lower rate of decline in forced vital capacity (FVC) compared with placebo, according to a study published online Sept. 29 in the New England Journal of Medicine to coincide with the European Respiratory Society International Congress 2019, held from Sept. 28 to Oct. 2 in Madrid.
Kevin R. Flaherty, M.D., from the University of Michigan in Ann Arbor, and colleagues conducted a double-blind phase 3 trial in 15 countries involving patients with fibrosing lung disease affecting more than 10 percent of lung volume on high-resolution computed tomography. Participants were randomly assigned to receive either nintedanib (150 mg twice daily) or placebo; 663 patients were treated.
The researchers found that the adjusted rate of decline in the FVC was −80.8 and −187.8 mL/year with nintedanib and placebo, respectively (between-group difference, 107.0 mL/year). In patients with a usual interstitial pneumonia-like pattern of fibrosis, the adjusted rate of FVC decline was −82.9 and −211.1 mL/year, respectively (between-group difference, 128.2 mL/year). The most common adverse event was diarrhea, which was reported in 66.9 and 23.9 percent of patients treated with nintedanib and placebo, respectively.
“We found that patients who received nintedanib had a slower rate of progression of interstitial lung disease than those who received placebo,” the authors write. “This change in physiological outcomes was not accompanied by meaningful changes in measures of quality of life.”
The study was funded by Boehringer Ingelheim, the manufacturer of nintedanib.
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