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Double-blind, placebo-controlled trial of pirfenidone in patients with idiopathic pulmonary fibrosis.
- Source :
-
American journal of respiratory and critical care medicine [Am J Respir Crit Care Med] 2005 May 01; Vol. 171 (9), pp. 1040-7. Date of Electronic Publication: 2005 Jan 21. - Publication Year :
- 2005
-
Abstract
- Idiopathic pulmonary fibrosis (IPF) is a fatal disorder without an effective therapy to date. In a double-blind, randomized, placebo-controlled trial, 107 patients were prospectively evaluated for efficacy of a novel compound, pirfenidone. The difference in the change in the lowest oxygen saturation by pulse oximetry (SpO2) during a 6-minute exercise test, the primary endpoint, from baseline to 6 months was not significant between the two groups (p = 0.0722). In a prespecified subset of patients who maintained a SpO2 greater than 80% during a 6-minute exercise test at baseline, the lowest SpO2 improved during a 6-minute exercise test in the pirfenidone group at 6 and 9 months (p = 0.0069 and 0.0305, respectively). Positive treatment effect was demonstrated in secondary endpoints: (1) change in VC measurements at 9 months (p = 0.0366) and (2) episodes of acute exacerbation of IPF occurring exclusively in the placebo group during the 9 months (p = 0.0031). Significant adverse events were associated with pirfenidone; however, adherence to treatment regimen was similar between pirfenidone and placebo groups. In conclusion, treatment with pirfenidone improved VC and prevented acute exacerbation of IPF during the 9 months of follow-up. Future long-term studies are needed to clarify the overall safety and efficacy of pirfenidone in IPF.
- Subjects :
- Aged
Anti-Inflammatory Agents, Non-Steroidal adverse effects
Double-Blind Method
Exercise physiology
Exercise Test
Female
Humans
Male
Middle Aged
Oxygen Consumption
Prospective Studies
Pulmonary Fibrosis physiopathology
Pyridones adverse effects
Total Lung Capacity
Vital Capacity
Anti-Inflammatory Agents, Non-Steroidal therapeutic use
Pulmonary Fibrosis drug therapy
Pyridones therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1073-449X
- Volume :
- 171
- Issue :
- 9
- Database :
- MEDLINE
- Journal :
- American journal of respiratory and critical care medicine
- Publication Type :
- Academic Journal
- Accession number :
- 15665326
- Full Text :
- https://doi.org/10.1164/rccm.200404-571OC