Abstract of ATS presentation of Shionogi Phase III Pirfenidone study.
[2:15 pm] A Phase III, Double-Blind, Placebo-Controlled Clinical Trial of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis in Japan, [Publication Page: A768]
T. Ogura, M.D., M. Ebina, M.D., H. Taniguchi, M.D., A. Azuma, M.D., M. Suga, M.D., Y. Taguchi, M.D., H. Takahashi, M.D., K. Nakata, M.D., A. Sato, M.D., T. Nukiwa, M.D., S. Kudoh, M.D., Yokohama, Japan
Background: To confirm encouraging results of the previous study of Pirfenidone (PFD), an anti-inflammatory and antifibrotic compound, in patients with idiopathic pulmonary fibrosis (IPF) in Japan (Am J Respir Crit Care Med, 171, 1040-47, 2005), that PFD might be effective in retarding progression of IPF and stabilizing pulmonary function, we conducted a double-blind, placebo-controlled, multicenter clinical trial of PFD in patients with IPF. Study design: A total of 275 patients were randomly assigned to high dose (1800 mg/day) of PFD group (H), low dose (1200 mg/day) of PFD group (L), and the placebo group (P) (H: L: P = 2: 1: 2). The primary endpoint was the change in vital capacity (VC), and a key secondary endpoint was the progression-free survival (PFS) defined as a period without an event of death or more than 10% decrease in VC. Results: Of 275 patients, 267 were included in the full analysis set (108 assigned to Group H, 55 to Group L, and 104 to Group P). PFD significantly affected the change in VC; at week 52, the difference in the adjusted mean change in VC from baseline between Group H and P was 0.07 liter (p=0.0416). PFD significantly affected the secondary endpoint of PFS: the difference between Group H and P was statistically significant (p=0.0280, Log-rank test). The most common adverse events reported in patients treated with PFD were photosensitivity in the skin and appetite loss. No significant difference in the serious adverse events was noted among three groups. Conclusion: The current study demonstrated that PFD therapy stabilized lung function and improved PFS in patients with IPF. With the safety and tolerability established, we conclude that PFD therapy is useful for treating patients with IPF. This abstract is funded by none.
Session Info: [**] Mini-Symposium, [C95] INTERSTITIAL LUNG DISEASE: EVALUATIONAL TREATMENT
Day/Date: Tuesday, May 20, 2008
Session Time: 1:30 PM - 4:15 PM
Presentation Time: 2:15 PM
Room: Room 717A-B (South Building, Level 700), Metro Toronto Convention Centre
