Background The search for effective treatment in idiopathic pulmonary fibrosis (IPF) has involved numerous clinical trials without significant success. However, in 2011, pirfenidone was the first drug to be approved for the treatment of IPF in Europe.

Purpose To evaluate the effectiveness and safety of pirfenidone.

Materials and methods A retrospective, longitudinal, observational and descriptive study from January 2012 to April 2013. Clinical data were obtained by medical record review of 3 patients undergoing treatment with pirfenidone for twelve, thirteen and fifteen months. The main clinical variable studied was the variation of the forced vital capacity (FVC) from basal levels, considering it a positive response to the treatment if FVC didn’t decrease more than 10%. Other variables analysed were: FEV1/FVC (increased in IPF), forced expiratory volume in one second (FEV1) and diffusion capacity of the lung for carbon monoxide (DLCO) (both decreased in IPF).

Results Two patients showed an FVC increase of 16.1% and 1.7%; in the third patient it decreased by 1.35%. FEV1 increased in all patients by 13.6%, 1.9% and 1.4%. FEV1/FVC increased in all patients by 2%, 0.26% and 2.31%. DLCO decreased in all cases at rates of: 8%, 6% and 2.4%. Adverse effects detected were: gastrointestinal disturbances and dyspepsia (3 patients), rash (2 patients), asthenia (2 patients), insomnia (1 patient), backache (1 patient), respiratory infection (1 patient), and diarrhoea (1 patient).

Conclusions In patients with idiopathic pulmonary fibrosis, pirfenidone has proven to be effective on the main variable FCV and secondary variable FEV1, but not on FEV1/FVC and DLCO. Detected adverse reactions matched with those described in the literature. Despite some indications of efficacy, further studies are required to evaluate the potential benefit.

No conflict of interest.