Efficacy and safety of sildenafil added to pirfenidone in patients with advanced idiopathic pulmonary fibrosis and risk of pulmonary hypertension: a double-blind, randomised, placebo-controlled, phase 2b trial

RCT (n=247) found no difference in the proportion of patients with disease progression over 52 weeks between sildenafil plus pifenidone (73%) and placebo plus pirfenidone (70% - between-group difference 3·06%, 95%CI −11·30 to +17·97, p=0·65).

The Lancet Respiratory Medicine