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.
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Authors | Arata Azuma, Toshihiro Nukiwa, Eiyasu Tsuboi, Moritaka Suga, Shosaku Abe, Koichiro Nakata, Yoshio Taguchi, Sonoko Nagai, Harumi Itoh, Motoharu Ohi, Atsuhiko Sato, Shoji Kudoh |
Journal | American journal of respiratory and critical care medicine
(Am J Respir Crit Care Med)
Vol. 171
Issue 9
Pg. 1040-7
(May 01 2005)
ISSN: 1073-449X [Print] United States |
PMID | 15665326
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Inflammatory Agents, Non-Steroidal
- Pyridones
- pirfenidone
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Topics |
- Aged
- Anti-Inflammatory Agents, Non-Steroidal
(adverse effects, therapeutic use)
- Double-Blind Method
- Exercise
(physiology)
- Exercise Test
- Female
- Humans
- Male
- Middle Aged
- Oxygen Consumption
- Prospective Studies
- Pulmonary Fibrosis
(drug therapy, physiopathology)
- Pyridones
(adverse effects, therapeutic use)
- Total Lung Capacity
- Vital Capacity
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