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DOI: 10.1055/s-0037-1598502
Reduction in Non-Elective Respiratory-Related Hospitalizations in Patients Treated With Pirfenidone: Pooled Analyses from Three Phase 3 Trials of Pirfenidone in Idiopathic Pulmonary Fibrosis
Publication History
Publication Date:
23 February 2017 (online)
Rationale:
Patients with idiopathic pulmonary fibrosis (IPF) are frequently hospitalized for a variety of reasons. Respiratory-related hospitalizations may occur because of acute exacerbations of IPF, respiratory tract infections, respiratory failure and other causes. Regardless of cause, respiratory-related hospitalizations have been linked to poor outcomes in patients with IPF. We describe the proportion of patients from the three Phase 3 pirfenidone IPF trials with at least one non-elective hospitalization (all-cause, respiratory- related and non-respiratory-related) over 12 months. Methods:
In three Phase 3 randomized, placebo-controlled studies of pirfenidone for IPF (CAPACITY I/II and ASCEND), patients were randomized to pirfenidone (2403 mg/day) or placebo. In the two CAPACITY studies, respiratory-related hospitalizations were a pre-specified endpoint. In ASCEND, hospitalizations were reported as adverse events (AEs), and retrospectively categorized as respiratory-related or non-respiratory by case review. The pooled rates of patients experiencing ≥1 non-elective hospitalizations (all-cause, respiratory-related and non-respiratory-related) for pirfenidone and placebo patients over 12 months are summarized. Rate of death post-hospitalization was also reported.
Results:
A total of 1,247 patients (692 CAPACITY and 555 ASCEND) were included (Table 1). In pooled analyses, the proportion of patients experiencing ≥1 all-cause hospitalizations over 12 months was no different between pirfenidone and placebo-treated patients. The proportion of patients experiencing ≥1 respiratory-related hospitalizations was 12% in the placebo group vs. 7% in the pirfenidone group (odds ratio 0.56; P = 0.004). Deaths after hospitalization were numerically reduced in the pirfenidone group, most substantially for respiratory-related hospitalizations.
All-Cause Hospitalizations |
Respiratory-Related Hospitalizations |
Non-Respiratory Hospitalizations |
||||
Hospitalizations |
Pirfenidone (N = 623) |
Placebo (N = 624) |
Pirfenidone (N = 623) |
Placebo (N = 624) |
Pirfenidone (N = 623) |
Placebo (N = 624) |
Events, n |
140 |
147 |
57 |
86 |
83 |
61 |
Patients with ≥1 event |
||||||
n (%) |
106 (17) |
112 (18) |
44 (7) |
74 (12) |
68 (11) |
51 (8) |
Odds ratio (95% CI) |
0.94 (0.70, 1.26) |
0.56 (0.38, 0.84) |
1.38 (0.94, 2.02) |
|||
P-value |
0.662 |
0.004 |
0.099 |
|||
Died after hospitalization, n (%) |
18 (17) |
37 (33) |
12 (27) |
34 (46) |
7 (10) |
9 (18) |
Conclusion:
Patients with IPF frequently require hospitalization for a variety of reasons. Pirfenidone may reduce the risk of non-elective respiratory-related hospitalizations over 12 months.