Riociguat: Extension study data
Interim 12-week data from the open-label, international PATENT-2 long-term extension trial of the double-blind, international Phase III PATENT-1 trial showed that thrice-daily oral riociguat further improved 6MWD from PATENT-1 baseline. Specifically, riociguat given for an additional 12 weeks improved 6MWD from PATENT-1 baseline by 53 meters in the former riociguat individual titration arm, 54 meters in the former capped riociguat titration arm and 42 meters in the former placebo arm. Additionally, riociguat improved WHO functional class in 34% of patients in the former riociguat individual titration arm, 33% of patients in the former capped riociguat titration arm and 22% of patients in the former placebo arm. In patients treated with riociguat for >=1 year, 6MWD increased by 48 meters from baseline and WHO functional class improved in 36% of patients. Riociguat was well tolerated with headache, dizziness, dyspepsia and hypotension reported as the most frequent treatment-related adverse events. Data were presented at the American Thoracic Society meeting in Philadelphia. ...