Riociguat for idiopathic interstitial pneumonia-associated pulmonary hypertension (RISE-IIP): a randomised, placebo-controlled phase 2b study

Publication date: Available online 12 August 2019Source: The Lancet Respiratory MedicineAuthor(s): Steven D Nathan, Jürgen Behr, Harold R Collard, Vincent Cottin, Marius M Hoeper, Fernando J Martinez, Tamera J Corte, Anne M Keogh, Hanno Leuchte, Nesrin Mogulkoc, Silvia Ulrich, Wim A Wuyts, Zhen Yao, Francis Boateng, Athol U WellsSummaryBackgroundIdiopathic interstitial pneumonias are often complicated by pulmonary hypertension, increasing morbidity and mortality. There are no approved treatments for pulmonary hypertension associated with idiopathic interstitial pneumonia (PH-IIP). We aimed to evaluate the efficacy and safety of riociguat in patients with PH-IIP.MethodsRISE-IIP was a double-blind, randomised, placebo-controlled study done at 65 pulmonary hypertension and interstitial lung disease centres in 19 countries to evaluate the efficacy and safety of riociguat in patients with PH-IIP. Eligible patients were adults (aged 18–80 years) diagnosed with idiopathic interstitial pneumonia (as per American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines), forced vital capacity (FVC) of at least 45%, 6MWD of 150–450 m, WHO functional classes II–IV, precapillary pulmonary hypertension confirmed by right heart catheterisation, systolic blood pressure of at least 95 mm Hg, and no signs or symptoms of hypotension. Patients were randomly allocated (1:1) using an interactive voice and web response system ...
Source: The Lancet Respiratory Medicine - Category: Respiratory Medicine Source Type: research