TY - JOUR T1 - Riociguat for the treatment of pulmonary arterial hypertension (PAH): A responder analysis from the phase III PATENT-1 study JF - European Respiratory Journal JO - Eur Respir J VL - 42 IS - Suppl 57 SP - 1783 AU - Ekkehard Grünig AU - Nazzareno Galiè AU - Marc Humbert AU - Anne M. Keogh AU - David Langleben AU - Lewis J. Rubin AU - Rudolf Speich AU - Arno Fritsch AU - Neil Davie AU - Hossein-Ardeschir Ghofrani Y1 - 2013/09/01 UR - http://erj.ersjournals.com/content/42/Suppl_57/1783.abstract N2 - BackgroundIn PATENT-1, riociguat significantly improved 6-min walking distance (6MWD) and a range of secondary endpoints, including hemodynamics, NT-proBNP, and WHO functional class (FC), in patients (pts) with PAH. For several of these endpoints, threshold criteria have been defined that correlate with favorable clinical outcome.AimsTo investigate the proportion of pts who fulfilled these criteria in PATENT-1.MethodsPATENT-1 was a double-blind randomized trial in which pts with PAH received 12 wks’ oral treatment with placebo, an individual titration of riociguat (up to 2.5 mg tid), or a capped titration of riociguat (up to 1.5 mg tid). Increase in 6MWD ≥40 m, 6MWD ≥380 m, cardiac index (CI) ≥2.5 L/min/m2, PVR <500 dyn·s·cm-5, mixed venous oxygen saturation (SvO2) ≥65%, FC I/II, and NT-proBNP <1800 pg/mL were chosen as criteria of a positive response based on studies showing their prognostic relevance at baseline (BL) and after targeted therapy.ResultsSimilar proportions of pts met the selected criteria in the riociguat and placebo groups at baseline. The proportion of pts who met these criteria at Wk 12 was increased in the riociguat group, while it remained unchanged or decreased in the placebo group.View this table:ConclusionsRiociguat increased the proportion of pts who fulfilled criteria defining a positive response to therapy. ER -