US drugmaker Gilead Sciences reported data from ARIES-3, an open-label, single-arm, Phase III study evaluating the efficacy and safety of ambrisentan in patients with pulmonary hypertension, which showed a mean 21-meter improvement from baseline in six-minute walk distance at 24 weeks.
According to the data from small study, which was not placebo controlled, at 24 weeks, 97% of patients were still alive. The probability of no clinical worsening at 24 weeks across all subjects was 90%, as assessed by Kaplan-Meier estimates.
Ambrisentan is approved under the trade name Letairis as a once-daily treatment for pulmonary arterial hypertension in patients with WHO functional class II or III symptoms to improve exercise capacity and delay clinical worsening. The ARIES-3 study included patients with PAH (WHO Group 1), as well as those with pulmonary hypertension due to other etiologies (WHO Groups 3, 4 and 5). Data from this study were presented at the 2009 American Thoracic Society International Conference, in San Diego.
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