Abstract
Background: Previous analyses of patients with IPF receiving pirfenidone showed that continued treatment following a ≥ 10% absolute or relative decline in percent predicted forced vital capacity (FVC) or hospitalization during the first 6 months of treatment provided a benefit during the subsequent 6 months.
Objective: To further explore the potential benefit of continued pirfenidone treatment in patients with IPF who had a worsening of 6MWD within the first 6 months of treatment.
Methods: A pooled analysis included all patients randomized to pirfenidone 2403 mg/d or placebo in the ASCEND and CAPACITY studies (N = 1247). All patients who had a 6MWD decline ≥ 15% within the first 6 months of study treatment were selected. FVC, 6MWD, mortality and hospitalization outcomes were assessed during the subsequent 6-month period.
Results: A total of 116/623 (18.6%) and 141/624 (22.6%) patients in the pooled pirfenidone and placebo groups, respectively, demonstrated a 6MWD decline ≥ 15% within the first 6 months of treatment. Outcomes during the subsequent 6 months of continued treatment in these patients are shown in the Table.
Conclusions: These results suggest that continued treatment with pirfenidone may confer a significant benefit to patients with IPF who experienced a 6MWD decline ≥ 15% within the first 6 months of treatment.
- Copyright ©the authors 2016
