Bosentan benefits in mild pulmonary arterial hypertension

kavin submitted, created time 4 months 3 weeks (www.thelancet.com)

The EARLY study, published in the June 21, 2008 issue of the Lancet, was conducted by a group led by Dr Nazzareno Galiè (University of Bologna, Italy).

They note that bosentan has been shown to improve exercise capacity, hemodynamics, and delay clinical worsening in two pivotal clinical trials, but in these, like other trials of treatments for pulmonary arterial hypertension, the vast majority of enrolled patients were in an advanced symptomatic state (WHO functional class 3 and 4). As the effect of pulmonary arterial hypertension treatments has never been explored exclusively in less compromised individuals, Galiè et al conducted the current study of bosentan in mildly symptomatic pulmonary arterial hypertension patients (WHO functional class 2).

In the EARLY study, 185 such patients were randomized to bosentan or placebo for a six-month treatment period. There were two co-primary end points: pulmonary vascular resistance at rest at month 6, expressed as a percentage of the baseline value; and change from baseline to month 6 in six-minute-walk distance. Results showed a significant improvement in pulmonary vascular resistance with bosentan and a trend toward improvement in exercise capacity, although the latter did not reach statistical significance.

Keywords: hemosynamics hypertension Bosentan pulmonary arterial hypertension Pulmonary Ossification