Pirfenidone in patients with idiopathic pulmonary fibrosis (CAPACITY): two randomised trials

@article{Noble2011PirfenidoneIP,
  title={Pirfenidone in patients with idiopathic pulmonary fibrosis (CAPACITY): two randomised trials},
  author={Paul W. Noble and Carlo Albera and Williamson Z. Bradford and Ulrich Costabel and Marilyn K. Glassberg and David R Kardatzke and Talmadge E. King and Lisa H Lancaster and Steven A. Sahn and Javier B Szwarcberg and Dominique Valeyre and Roland M. du Bois},
  journal={The Lancet},
  year={2011},
  volume={377},
  pages={1760-1769}
}
BACKGROUND Idiopathic pulmonary fibrosis is a progressive and fatal lung disease with inevitable loss of lung function. [...] Key MethodMETHODS In two concurrent trials (004 and 006), patients (aged 40-80 years) with idiopathic pulmonary fibrosis were randomly assigned to oral pirfenidone or placebo for a minimum of 72 weeks in 110 centres in Australia, Europe, and North America.Expand
Pirfenidone in patients with idiopathic pulmonary fibrosis and more advanced lung function impairment.
TLDR
Pfenidone demonstrated clinically relevant benefits across multiple domains in patients with IPF and more advanced disease without an increased risk of discontinuation due to TEAEs. Expand
A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis.
TLDR
Pirfenidone, as compared with placebo, reduced disease progression, as reflected by lung function, exercise tolerance, and progression-free survival, in patients with idiopathic pulmonary fibrosis. Expand
Pirfenidone should be prescribed for patients with idiopathic pulmonary fibrosis
TLDR
Patients treated with pirfenidone had slower rates of decline in lung volume and vital capacity than placebo, and in three studies, the results were statistically significant. Expand
Pirfenidone: in idiopathic pulmonary fibrosis.
TLDR
Patients with IPF who received pirfenidone had an acceptable tolerability profile in clinical trials, with most adverse events being mild to moderate in severity. Expand
Macitentan for the treatment of idiopathic pulmonary fibrosis: the randomised controlled MUSIC trial
TLDR
Long-term exposure to macitentan was well tolerated with a similar, low incidence of elevated hepatic aminotransferases in each treatment group, and the primary objective was not met. Expand
Pirfenidone for idiopathic pulmonary fibrosis, thrombocytosis in chronic obstructive pulmonary disease exacerbations, and a longitudinal study on e-cigarettes.
TLDR
This study confirmed the promise and efficacy of pirfenidone noted in the prior two CAPACITY trials, and FVC and 6-minute-walk distances were maintained for longer periods of time in patients on pirfenidsone. Expand
The role of pirfenidone in the treatment of idiopathic pulmonary fibrosis
TLDR
The efficacy data, coupled with long-term safety data, provide further evidence of a clinically-meaningful treatment effect with pirfenidone in patients with IPF. Expand
Pirfenidone in idiopathic pulmonary fibrosis: the CAPACITY program
TLDR
Positive results were obtained in two almost identical double-blind placebo-controlled studies assessing the effects of pirfenidone on change in forced vital capacity, the primary end point, over a 72-week period. Expand
Double-Blind Randomized Trial of Pirfenidone in Chinese Idiopathic Pulmonary Fibrosis Patients
TLDR
It is shown that pirfenidone combined with high-dose NAC prolonged the progression-free survival of Chinese IPF patients with mild to moderate impairment of pulmonary function and n-acetylcysteine exerted antioxidant and antifibrotic effects on IPF cases. Expand
Pirfenidone: A Review of Its Use in Idiopathic Pulmonary Fibrosis
TLDR
Oral pirfenidone is a valuable agent for use in patients with IPF and a prespecified mortality analysis across all three studies demonstrated a significant reduction in IPF-related and all-cause mortality with pirfenidsone. Expand
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References

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Pirfenidone in idiopathic pulmonary fibrosis
TLDR
Although photosensitivity, a well-established side-effect of pirfenidone, was the major adverse event in this study, it was mild in severity in most of the patients and relatively well tolerated in patients with IPF. Expand
Pirfenidone in idiopathic pulmonary fibrosis: A phase III clinical trial in Japan
Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease without proven effective therapy. A multi-centered, double-blind, placebo-controlled, randomized phase III clinical trial wasExpand
Double-blind, placebo-controlled trial of pirfenidone in patients with idiopathic pulmonary fibrosis.
TLDR
Treatment with pirfenidone improved VC and prevented acute exacerbation of IPF during the 9 months of follow-up, and adherence to treatment regimen was similar between pirfenidsone and placebo groups. Expand
A placebo-controlled trial of interferon gamma-1b in patients with idiopathic pulmonary fibrosis.
TLDR
In a well-defined population of patients with idiopathic pulmonary fibrosis, interferon gamma-1b did not affect progression-free survival, pulmonary function, or the quality of life. Expand
High-dose acetylcysteine in idiopathic pulmonary fibrosis.
TLDR
Therapy with acetylcysteine at a dose of 600 mg three times daily, added to prednisone and azathioprine, preserves vital capacity and DL(CO) in patients with idiopathic pulmonary fibrosis better than does standard therapy alone. Expand
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TLDR
In a randomized, placebo-controlled trial of patients with mild to moderate IPF followed for 96 weeks, imatinib did not affect survival or lung function. Expand
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TLDR
Treatment with interferon gamma-1b did not improve survival for patients with idiopathic pulmonary fibrosis, which refutes previous findings from subgroup analyses of survival in studies of patients with mild-to-moderate physiological impairment of pulmonary function. Expand
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TLDR
The primary objective in the Bosentan Use in Interstitial Lung Disease-3 trial was not met and bosentan was well tolerated. Expand
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TLDR
To assess the efficacy of non-steroid agents in adults with idiopathic pulmonary fibrosis, 15 trials involving 10 different drugs were included and survival outcomes were combined using Peto odds ratios or hazard ratios. Expand
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TLDR
Pirfenidone appears to improve progression-free survival and, to a lesser extent, pulmonary function in patients with idiopathic pulmonary fibrosis, and more data are needed on overall survival and quality of life on treatment. Expand
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