Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis
Author Information
Author(s): Taniguchi Hiroyuki, Kondoh Yasuhiro, Ebina Masahito, Azuma Arata, Ogura Takashi, Taguchi Yoshio, Suga Moritaka, Takahashi Hiroki, Nakata Koichiro, Sato Atsuhiko, Sugiyama Yukihiko, Kudoh Shoji, Nukiwa Toshihiro
Primary Institution: Dept of Respiratory Medicine and Allergy, Tosei General Hospital, Seto, Aichi, Japan
Hypothesis
Can a 5% change in vital capacity serve as a prognostic factor for patients with idiopathic pulmonary fibrosis treated with pirfenidone?
Conclusion
Pirfenidone is effective in reducing the decline of vital capacity in patients with idiopathic pulmonary fibrosis, and a 5% change in vital capacity can be a useful prognostic factor.
Supporting Evidence
- Statistically significant differences in improvement ratings were observed at months 3, 6, 9, and 12 between pirfenidone and placebo groups.
- Risk reductions by pirfenidone to placebo were approximately 35% over the study period.
- The positive predictive value for the placebo group was 86.1%, while for the pirfenidone group it was 87.1%.
- Patients with a 5% decline in VC at month 3 had significantly worse clinical outcomes after 1 year.
Takeaway
This study shows that a small change in lung function can help doctors understand how well a treatment is working for patients with a serious lung disease.
Methodology
A multicenter, double-blind, randomized, placebo-controlled trial comparing high-dose and low-dose pirfenidone with placebo over 52 weeks.
Limitations
The study had a small number of subjects with death or acute exacerbation within the one-year study period.
Participant Demographics
Adults aged 20 to 75 years with a diagnosis of idiopathic pulmonary fibrosis.
Statistical Information
P-Value
p = 0.0015
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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