Nintedanib and Sildenafil in Patients with Idiopathic Pulmonary Fibrosis and Right Heart Dysfunction. A Prespecified Subgroup Analysis of a Double-Blind Randomized Clinical Trial (INSTAGE).

American Journal of Respiratory and Critical Care Medicine
Jürgen BehrFernando J Martinez

Abstract

Rationale: In the INSTAGE trial in patients with idiopathic pulmonary fibrosis (IPF) and severely impaired gas exchange, nintedanib plus sildenafil was associated with numerical benefits on St. George's Respiratory Questionnaire (SGRQ) total score, brain natriuretic peptide (BNP), and FVC decline versus nintedanib alone. Exploratory analyses of the STEP-IPF (Sildenafil Trial of Exercise Performance in IPF) trial suggested that sildenafil may have a greater effect on SGRQ score in patients with IPF who have right heart dysfunction (RHD).Objectives: Assess whether RHD influenced the effects of nintedanib plus sildenafil versus nintedanib alone in the INSTAGE trial.Methods: Subgroup analyses of patients with (n = 117) versus those without (n = 156) echocardiographic signs of RHD at baseline.Measurements and Main Results: There was no heterogeneity between subgroups by presence of RHD in the effect of nintedanib plus sildenafil versus nintedanib alone on change in SGRQ total score at Week 12 (P = 0.74) or Week 24 (P = 0.90), or change in FVC at Week 12 (P = 0.58) or Week 24 (P = 0.55). In both subgroups, nintedanib plus sildenafil had a numerically greater effect on reducing FVC decline versus nintedanib alone. Between-group differ...Continue Reading

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Citations

Apr 21, 2020·American Journal of Respiratory and Critical Care Medicine·Elena A GoncharovaMark T Gladwin
Jul 14, 2020·Current Opinion in Pulmonary Medicine·Eileen M Harder, Aaron B Waxman
May 16, 2020·American Journal of Respiratory and Critical Care Medicine·Sydney B MontesiKerri A Johannson
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Feb 1, 2021·The Journal of Heart and Lung Transplantation : the Official Publication of the International Society for Heart Transplantation·Khodr TelloHenning Gall
Apr 10, 2021·The Journal of Heart and Lung Transplantation : the Official Publication of the International Society for Heart Transplantation·Reda E Girgis, Marius M Hoeper
May 18, 2021·Frontiers in Immunology·Chiel van GeffenSaeed Kolahian
Jul 10, 2021·Curēus·Sherif T AbuserewaGregory Becker
Sep 10, 2021·Scientific Reports·Jieun Kang, Jin Woo Song

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