Efficacy And Safety Of Pirfenidone In Patients With Idiopathic Pulmonary Fibrosis: A Phase Iii Randomized, Double-Blind, Placebo-Controlled Trial
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Abstract
The idiopathic pulmonary fibrosis (IPF) implies the disabling disease of lungs with low-favorable prognosis and the development of which regularly results in death of an individual within 3-5 years unless the disorder is effectively treated. Pirfenidone: An experimental treatment proposed, this agent is an antifibrotic, anti-inflammatory, antioxidant agent which has been seen to work with experimental IPF models. This was a particularly double blind study, placebo-controlled, randomized, and phase III study that was carried out with the purpose of establishing efficacy of pirfenidone in test to determine its efficacy and safety in Patients individuals with IPF. Volunteers were randomly chosen (n = 170) and separated into the following groups by using the method of randomized assigning; high dose (1,800 mg/day), low dose (1,200 mg/day) and placebo. The outcome of change in the vital capacity (VC) at week 0 and week 52 was the most required one. The other secondary outcome measures included progression free survival (PFS) and the difference in the minimal oxygen saturation (Sp,O2) during steady-state 6-minute exercise test (6MET). This had resulted in an enhanced average improvement in VC and PFS by the concentration of high dose and low pirfenidone group which is significantly much more than that conducted by the option of placebo. Nevertheless, the shift of the lowest Sp,O2 resulted in an insignificant change in the groups. The most reported ones were photosensibility and numerous adverse effects in the gastrointestinal system, including anorexia, especially in the series of the high dosages of the drug. The overall administration of pirfenidone was quite well tolerated, even though they have some side effects. Such evidence demonstrates that pirfenidone will positively affect the lung functions and delay the disease progression in IPF patients who are at low stages of functional limitation and that are not exposed to significant adverse events. Such results have not been confirmed through post-hoc adjustment of results, and also it studies the benefits in the future.
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References
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