Posts Tagged ‘pulmonary arterial hypertension’

September 25th, 2014

Pulmonary Arterial Hypertension Treatment Worldwide: A Lack of Standardized Care

John Ryan discusses his new paper on heterogeneity in pulmonary arterial hypertension clinical practice worldwide. Are you surprised by the lack of standardized care?

September 18th, 2014

Do Hemodynamic Endpoints Have Value in Patients Treated for Pulmonary Arterial Hypertension?

Corey E. Ventetuolo discusses her research group’s study of hemodynamic endpoints in clinical trials of patients with pulmonary arterial hypertension.

June 16th, 2014

Positive Results for New Oral Pulmonary Arterial Hypertension Drug

Actelion has announced positive top-line results for a phase III trial of a new oral drug for the treatment of pulmonary arterial hypertension (PAH). The drug, selexipag, is a first-in-class orally available selective prostacyclin IP receptor agonist. The pivotal, double-blind GRIPHON study was the largest outcome trial ever performed in PAH. A total of 1,156 PAH patients were randomized to selexipag or placebo. […]

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 […]

January 31st, 2014

A (Not So) New Drug Landscape for Pulmonary Arterial Hypertension

John Ryan offers a primer on three newly approved drugs for pulmonary arterial hypertension.

October 18th, 2013

FDA Approves New Pulmonary Hypertension Drug from Actelion

The FDA today approved macitentan (Opsumit, Actelion), a new oral endothelin-receptor antagonist that is an enhanced version of the company’s bosentan (Tracleer). The drug is indicated to delay disease progression in patients who have pulmonary arterial hypertension (WHO Group I). Last August the results of the pivotal phase 3 trial, SERAPHIN (Study with an Endothelin Receptor Antagonist in Pulmonary […]

September 11th, 2013

A New Standard For Pulmonary Hypertension Trials

Recently the New England Journal of Medicine published the SERAPHIN trial studying the effects of macitentan, a new endothelin receptor antagonist, in pulmonary arterial hypertension (PAH). This was a well-conducted study in 742 patients with PAH randomized to placebo, a low dose of macitentan (3mg once a day) and a high dose of macitentan (10mg once […]

August 28th, 2013

New Drug Found Safe and Effective in Pulmonary Arterial Hypertension — But Does It Save Lives?

Macitentan, a new drug for pulmonary arterial hypertension (PAH), appears to be safe and effective, but it is unclear whether it offers any significant advantages over currently available drugs.  The drug, a dual endothelin-receptor antagonist, is under development from Actelion as an enhanced version of bosentan (Tracleer). The results of a phase 3 trial, SERAPHIN (Study with an Endothelin […]

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.