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Pirfenidone

In Idiopathic Pulmonary Fibrosis

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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.

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Acknowledgements and Disclosures

The manuscript was reviewed by: D. Bouros, Department of Pneumonology, University Hospital and Medical School Democritus University of Thrace, Alexandroupolis, Greece; J. Egan, Heart and Lung Transplant Programme, Mater Misericordiae Hospital, Dublin, Ireland; T. Nukiwa, Department of Respiratory Medicine, Ohoku University Graduate School of Medicine, Sendai, Japan.

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was also offered an opportunity to comment on this article. Changes resulting from comments received were made by the author on the basis of scientific and editorial merit.

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    Natalie J. Carter

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Correspondence to Natalie J. Carter.

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Carter, N.J. Pirfenidone. Drugs 71, 1721–1732 (2011). https://doi.org/10.2165/11207710-000000000-00000

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