Posts Tagged ‘pulmonary hypertension’

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March 17th, 2014

Phase 4 Actelion Study Misses Primary Endpoint

Actelion announced today that a phase 4 study with its blockbuster drug bosentan (Tracleer) had failed to meet its primary endpoint. The COMPASS-2 trial was a prospective, randomized, double-blind, placebo-controlled trial evaluating the effect of bosentan on the time to first confirmed event in patients with symptomatic pulmonary arterial hypertension (PAH) already receiving treatment with sildenafil. According to the company, a 17% risk […]


October 9th, 2013

New Drug for Pulmonary Hypertension Approved by FDA

The FDA approved on Tuesday a new drug for pulmonary hypertension. Bayer HealthCare’s riociguat (brand name Adempas) was approved for two indications: the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class the treatment of adults with pulmonary arterial hypertension (PAH) to improve […]


August 7th, 2013

FDA Panel Recommends Approval of New Pulmonary Hypertension Drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee recommended approval for Bayer’s new pulmonary hypertension drug, riociguat. The committee voted 11-0 in favor of approving the drug for two forms of pulmonary hypertension: pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTPH). Bayer proposed an initial dose of 1 mg three times daily and a maximum dose of 2.5 […]


July 25th, 2013

Novel Pulmonary Hypertension Drug Shows Modest Promise in Phase 3 Trials

A new drug appears to have promising — but not game-changing — effects in people with two forms of pulmonary hypertension. Riociguat, a soluble guanylate cyclase stimulator under development by Bayer, is thought to have vasodilating, antiproliferative, and antifibrotic effects. Results of two phase 3, placebo-controlled trials were published today in the New England Journal of Medicine. CHEST-1 studied the clinical […]


July 25th, 2013

The Changing Landscape of Pulmonary Hypertension

Two multicenter clinical trials published in the New England Journal of Medicine explore the role of a new oral pulmonary vasodilator in pulmonary hypertension.


May 1st, 2013

Which Wedge to Believe?

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Offer your diagnosis of a 39-year-old man with severe pulmonary hypertension and markedly variable pulmonary capillary wedge pressures among lung segments.