Comprehensive assessment of the long-term safety of pirfenidone in patients with idiopathic pulmonary fibrosis.
Bottom Line: Gastrointestinal and skin-related events were the most commonly reported adverse events; these were almost always mild to moderate in severity, and rarely led to treatment discontinuation.Elevations (>3× upper limit of normal) in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) occurred in 21/789 (2.7%) patients; the adjusted incidence of AST/ALT elevations was 1.7 per 100 PEY.This comprehensive analysis of safety in a large cohort of IPF patients receiving pirfenidone for a total of 2059 PEY demonstrates that long-term treatment with pirfenidone is safe and generally well tolerated.
Affiliation: Hospital Avicenne, Assistance Publique-Hôpitaux de Paris, Bobigny, France.Show MeSH
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Mentions: All patients who were randomized to treatment with pirfenidone and received at least one dose of study drug in the Phase 3 CAPACITY studies and all patients who received at least one dose of pirfenidone in one of two ongoing open-label studies were included in the analysis (Fig. 1). The CAPACITY studies (Study 004 and Study 006) were randomized, double-blind, placebo-controlled studies evaluating pirfenidone in patients with IPF. The open-label studies included Study 002, a compassionate-use study in patients with either IPF or secondary pulmonary fibrosis, and Study 012 (RECAP), an open-label extension study in patients who completed either of the two CAPACITY studies or the ongoing ASCEND study (patients who completed the ASCEND study enrolled in Study 012 after the interim data cut-off date and were therefore not included in the analysis).
Affiliation: Hospital Avicenne, Assistance Publique-Hôpitaux de Paris, Bobigny, France.