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Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS)
Date:5/19/2009

of IPF-related deaths during treatment was also lower among patients treated with pirfenidone. IPF-related deaths occurred during the treatment period in 4.1% of patients in the pirfenidone group and 8.1% of patients in the placebo group in CAPACITY 1. IPF-related deaths occurred during the treatment period in 2.9% of pirfenidone group and 6.3% of patients in the placebo group in CAPACITY 2.

Treatment Discontinuation due to Adverse Events

Pirfenidone was safe and generally well tolerated. Relatively few adverse events resulted in treatment discontinuations. The percentage of patients in the 2403 mg pirfenidone and placebo groups across both CAPACITY studies who discontinued treatment (pirfenidone/placebo) due to various adverse events were as follows: IPF (2.9/2.6); rash (1.4/0); nausea (1.4/0); bladder cancer (0.9/0); photosensitivity reaction (0.9/0.3); respiratory failure (0.9/0.3) and weight decrease (0.6/0).

Laboratory Tests

A total of 30 laboratory tests were regularly performed in CAPACITY. The incidence of grade 3/4 laboratory abnormalities was similar between treatment groups in both studies. In six of the tests, Grade 3/4 abnormalities were noted slightly more frequently in patients treated with pirfenidone (phosphate elevation, hyponatremia, lymphopenia, ALT elevation, AST elevation and cholesterol elevation). Of these laboratory abnormalities in pirfenidone patients, all but one case each of hyponatremia and lymphopenia were Grade 3. In four of the laboratory tests, Grade 3/4 abnormalities were noted slightly more frequently in patients treated with placebo (urate elevation, hyperkalemia, amylase elevation and creatine kinase elevation). Both the incidence of grade 3/4 lab abnormalities and the differences observed between treatment groups on all tests were small.

Regarding the overall safety results, Dr. du Bois commented, "The safety and tolerabilit
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SOURCE InterMune, Inc.
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