title: Pirfenidone: in idiopathic pulmonary fibrosis.
abstract: Pirfenidone is an orally administered pyridine that has orphan designation for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF) in the EU. Pirfenidone 2403 mg/day for 72 weeks administered to patients with IPF was associated with a significantly lower mean decline in the percent predicted forced vital capacity than placebo (primary endpoint) according to data from one of two randomized, double-blind, multinational trials (studies 004 and 006 [also known as the CAPACITY trials]), and data from a pooled analysis of both trials. In another randomized, double-blind, multicentre Japanese trial, the adjusted mean in the change in vital capacity from baseline to week 52 was significantly lower in patients with IPF who received pirfenidone 1800 mg/day (considered to be comparable to the 2403 mg/day dose in studies 004 and 006 on a weight-normalized basis) than in those who received placebo (primary endpoint). Pirfenidone had an acceptable tolerability profile in clinical trials, with most adverse events being mild to moderate in severity.
authors: Adis, a Wolters Kluwer Business, Auckland, New Zealand.
authors: Natalie J
authors: NJ
authors: Carter
mesh_terms: D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D006801:Humans; D054990:Idiopathic Pulmonary Fibrosis / Q000188:drug therapy* / Q000503:physiopathology; D011728:Pyridones / Q000737:chemistry / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D011728:Pyridones; C093844:pirfenidone