Riociguat for idiopathic interstitial pneumonia-associated pulmonary hypertension (RISE-IIP): A randomised, placebo-controlled phase 2b study
The Lancet Respiratory Medicine Sep 09, 2019
Nathan SD, Behr J, Collard HR, et al. - In this double-blind, randomised, placebo-controlled study, the RISE-IIP, researchers assessed the efficacy as well as safety of riociguat in patients with pulmonary hypertension associated with idiopathic interstitial pneumonia (PH-IIP). This inquiry was undertaken at 65 pulmonary hypertension and interstitial lung disease centres in 19 countries. Using randomization (1:1), the participants were administered riociguat (0·5–2·5 mg three times daily) or placebo for 26 weeks (main study). Thereafter, an open-label extension was performed wherein riociguat was administered to all patients. Change in 6-min walking distance in the intention-to-treat population was assessed as the primary endpoint. Eighty-two participants were removed, the remaining 147 were randomly allotted to treatment (73 to riociguat, 74 to placebo). Increased serious adverse events and mortality, as well as an unfavourable risk–benefit profile, were observed in relation to riociguat treatment in patients with PH-IIP. Experts recommend abandoning this drug for use in these patients.
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