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A Double-blind, Multicenter Study Comparing Pirfenidone and Prednisone for Moderate-to-Severe Pulmonary Fibrosis FREE TO VIEW

Selman Moises, MD; Carlos E. Girod, MD; Adrian Shifren, MD; Andrea Estrada, MD; John E. Fitzgerald, MD; Sharon Safrin, MD; Williamson Z. Bradford, MD
Author and Funding Information

Instituto Nacional de Enfermedades Respiratorias, Tlalpan, Mexico


Chest. 2003;124(4_MeetingAbstracts):116S. doi:10.1378/chest.124.4_MeetingAbstracts.116S-b
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PURPOSE:  Oral pirfenidone (PFD) is a small synthetic non-peptide molecule with antifibrotic and anti-inflammatory properties in experimental models. Preliminary clinical studies in idiopathic pulmonary fibrosis (IPF) have shown promise.

METHODS:  Patients with pulmonary fibrosis were randomized (1:1) to receive oral PFD (40 mg/kg/d) or prednisone (PDN; 0.33 mg/kg/d) in a double-blind, multicenter trial. Entry requirements included VC, TLC, DLCO, and FEV1 >= 35% and O2saturation >= 75%. Pulmonary function tests and 6MWT were performed every 3 months. All patients with IPF with >= 1 post-baseline measurement were analyzed for efficacy (N=44). Safety analysis included all enrolled patients who received >= 1 dose of study drug (N=52).

RESULTS:  Fifty-three patients were enrolled, of whom 46 had IPF. Mean age = 65 years; mean baseline FVC = 57%; mean duration of treatment ∼ 1 year. Fifty-seven percent of patient completed 12 months of treatment. Results are presented in Table 1

Results Mean Change from Baseline at 12 Months(1)

Pirfenidone (N=24)Prednisone (N=20)p ValueDistance walked, 6-min walk test (6MWT) [meters]−12.8−72.50.1Minimum O2 saturation in 6MWT (%)1.8−2.90.01% FVC−4.2−7.30.2% TLC−5.3−4.20.8A-a gradient− last observation carried forward.Ten patients died (5 PFD, 5 PDN). Treatment was discontinued due to an adverse event in 5 patients (2 PFD, 3 PDN). Nausea, weight loss, and dyspepsia were the most commonly reported side effects in PFD patients, while increased weight was most frequent in PDN patients.CONCLUSIONS: The tolerability of PFD, as well as the efficacy results from the 6MWT and other physiologic measures, are encouraging and warrant further study.

CLINICAL IMPLICATIONS:  These data suggest possible utility of oral PFD in the treatment of IPF.

DISCLOSURE:  S. Moises, InterMune, Inc., Grant monies.

Tuesday, October 28, 2003

2:30 PM - 4:00 PM




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