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FDA Approves New Drug for Two Types of Pulmonary Hypertension — Physician’s First Watch
FDA Approves New Drug for Two Types of Pulmonary Hypertension
By Kristin J. Kelley
Riociguat (marketed as Adempas) has been approved to improve exercise capacity in adults with chronic thromboembolic pulmonary hypertension after surgery and pulmonary arterial hypertension of unknown origin.
Approval for the drug — a soluble guanylate cyclase stimulator that decreases blood pressure and increases blood flow — was based on two randomized trials of some 700 patients. In both studies, patients who received riociguat could walk at least 36 meters farther in 6 minutes than those on placebo after 12 to 16 weeks of treatment.
Common treatment side effects include diarrhea, dizziness, dyspepsia, headache, nausea, peripheral edema, and vomiting.