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Pirfenidone in idiopathic pulmonary fibrosis: high incidence of adverse events but mostly manageable


Pirfenidone ( Esbriet ) is a novel antifibrotic drug for the treatment of mild-to-moderate idiopathic pulmonary fibrosis ( IPF ). However, adverse events may offset treatment benefits and compliance.

The objective of a study was to assess recent course of disease, adverse events and compliance in patients who started Pirfenidone.

In an observational cohort study, 63 patients with mild-to-moderate idiopathic pulmonary fibrosis who started Pirfenidone between May 2011 and June 2013 were reviewed.
Disease progression was defined as a reduction of vital capacity greater than or equal to 10% and/or diffusion capacity ( DLCO ) greater than or equal to 15%.

Follow-up time on Pirfenidone treatment was 11 ( ±7 ) months. Sixty-six percent of the patients continued with Pirfenidone monotherapy and 34% of the patients received Pirfenidone combined with corticosteroids ( CCS ) and/or N-acetylcysteine ( NAC; Acetylcysteine ).

There was a nonsignificant reduction in mean decline of percent predicted forced vital capacity after treatment start ( 0.7 ± 10.9% ) compared to the pretreatment period ( 6.6 ± 6.7%, p = 0.098 ).

Sixty-two percent of the patients had stable disease on Pirfenidone treatment.

Adverse events affected 85% of the patients, leading to discontinuation of Pirfenidone in 20%. Adverse events and treatment discontinuation were seen more frequently in patients with concomitant corticosteroids and/or Acetylcysteine treatment.

In conclusion, adverse events affect the majority of patients treated with Pirfenidone, but are mostly manageable with supportive measures.
In this heterogeneous patient group, a nonsignificant effect of Pirfenidone treatment on pulmonary function was seen, underlining the need for more data on patient selection criteria and efficacy of Pirfenidone, particularly in patients with coexistent emphysema and concomitant Acetylcysteine / corticosteroids treatment. ( Xagena )

Oltmanns U et al, Respiration 2014;88:199-207

XagenaMedicine_2014



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