my personal edition > pulmonary other > news
E-Mail this DGNews to a colleague
DGNews
EU Extends Indication of Bosentan to Pulmonary Arterial Hypertension WHO FC II
NEW YORK -- August 6, 2008 -- The European Union (EU) has approved bosentan (Tracleer) for the treatment of patients with mildly symptomatic pulmonary arterial hypertension (PAH World Health Organization [WHO] functional class [FC] II).
The approval is based on the results from the Endothelin Antagonist Trial in Mildly Symptomatic PAH Patients (EARLY).
The randomised, double-blind, placebo-controlled study of 185 patients showed that pulmonary vascular resistance improved significantly, with a reduction of 22.6% (P < .0001) after 6 months compared with placebo.
A 77% risk reduction in time to clinical worsening (P = .011) was seen after 6 months compared with placebo. Patients receiving bosentan had a lower incidence of worsening functional class (3.4%) compared with placebo (13.2%).
The safety and tolerability profile of bosentan in the EARLY study was consistent with that observed in previous placebo-controlled clinical trials.
SOURCE: Actelion Ltd.
All contents Copyright (c) 1995-2009 Doctor's Guide Publishing Limited. All rights reserved.
| 
