Effects of Pirfenidone on Idiopathic Pulmonary Fibrosis Progression and Safety: Results of Multicenter Prospective Observational Study.
Sergey N AvdeevMikhail IlkovichStanislav TerpigorevSergey MoiseevIgor TyurinPublished in: Life (Basel, Switzerland) (2023)
The aim of this study was to determine the effectiveness of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF) seen in clinical practice. Fifty-five adults with IPF were enrolled in this multicenter, open-label, non-randomized, non-controlled, interventional clinical study. All patients received pirfenidone 2403 mg/day (three 267 mg capsules three times daily) for 26 weeks. After 26 weeks of treatment, the mean change in absolute forced vital capacity (FVC) was 128.8 mL (95% confidence interval [CI] -26.8, 284.4) and the mean change in relative predicted FVC was -0.10% (95% CI -3.18, 2.99). Stable disease (defined as improvement of ≥0% or a decline of <10% to 0% of the corresponding FVC value) was observed in most patients (relative FVC, 90.9%; absolute FVC, 83.6%). There was no statistically significant change in the mean high-resolution computed tomography fibrosis score or lung opacity score at week 26 compared with baseline. Treatment-emergent adverse events were reported in 80% of patients during the treatment period; most of them were mild or moderate in severity. No serious pirfenidone-related adverse events were observed during the study period. Pirfenidone was generally safe and effective for controlling functional decline and stabilizing disease in patients with IPF encountered in clinical practice in Russia.
Keyphrases
- idiopathic pulmonary fibrosis
- interstitial lung disease
- end stage renal disease
- computed tomography
- ejection fraction
- clinical practice
- open label
- prognostic factors
- high resolution
- systematic review
- squamous cell carcinoma
- clinical trial
- peritoneal dialysis
- double blind
- magnetic resonance imaging
- randomized controlled trial
- combination therapy
- magnetic resonance
- radiation therapy
- cross sectional
- mass spectrometry
- physical activity
- placebo controlled
- high intensity
- liquid chromatography
- phase iii
- systemic sclerosis
- gestational age
- locally advanced
- pet ct
- tandem mass spectrometry