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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)
- Source :
- American Journal of Respiratory and Critical Care Medicine
- Publication Year :
- 2019
- Publisher :
- American Thoracic Society, 2019.
-
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 differences in change in BNP at Week 24 were −119.9 ng/L (95% confidence interval = −171.3 to −68.5) and −3.6 ng/L (95% confidence interval = −47.2 to 40.0) in patients with and without signs of RHD at baseline, respectively (P
- Subjects :
- Male
Pulmonary and Respiratory Medicine
medicine.medical_specialty
Indoles
medicine.drug_class
Sildenafil
Ventricular Dysfunction, Right
Subgroup analysis
Critical Care and Intensive Care Medicine
Sildenafil Citrate
Tyrosine-kinase inhibitor
law.invention
Interstitial Lung Disease/Pulmonary Vascular Disease
03 medical and health sciences
chemistry.chemical_compound
Idiopathic pulmonary fibrosis
tyrosine kinase inhibitor
0302 clinical medicine
Double-Blind Method
Randomized controlled trial
law
Internal medicine
pulmonary hypertension
medicine
Humans
030212 general & internal medicine
Protein Kinase Inhibitors
Aged
interstitial lung disease
Aged, 80 and over
business.industry
Editorials
Interstitial lung disease
Original Articles
Middle Aged
Phosphodiesterase 5 Inhibitors
medicine.disease
Pulmonary hypertension
Idiopathic Pulmonary Fibrosis
respiratory tract diseases
right ventricular function
Treatment Outcome
030228 respiratory system
chemistry
Cardiology
Drug Therapy, Combination
Female
Nintedanib
business
Subjects
Details
- ISSN :
- 15354970 and 1073449X
- Volume :
- 200
- Database :
- OpenAIRE
- Journal :
- American Journal of Respiratory and Critical Care Medicine
- Accession number :
- edsair.doi.dedup.....1b30cf132e44f1977be86177ef9f6d09