A new study published in Lancet online reported the results from two randomized trials that pirfenidone has a favourable benefit risk profile and represents an appropriate treatment option for patients with idiopathic pulmonary fibrosis [1]. These two trials were designed to test pirfenidone 2403 mg/day and 1197 mg/day. In one trials, high-dose pirfenidone significantly reduced the decline in % pred FVC. A consistent pirfenidone treatment effect was found up to week 48. A significant reduction in the decline from baseline to week 72 in 6MWT distance was observed in patients with pirfenidone treatment. Pirfenidone prolonged progression-free survival by 26% compared with placebo.
These trials are encouraging in gaining FDA approval use of pirfenidone in the US.
[1] Noble PW, et al. Pirfenidone in patients with idiopathic pulmonary fibrosis
(CAPACITY): two randomised trials. Lancet. 2011 May 13. [Epub ahead of print]
PubMed PMID: 21571362.
These trials are encouraging in gaining FDA approval use of pirfenidone in the US.
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| Fig 1A. |
[1] Noble PW, et al. Pirfenidone in patients with idiopathic pulmonary fibrosis
(CAPACITY): two randomised trials. Lancet. 2011 May 13. [Epub ahead of print]
PubMed PMID: 21571362.
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