Gilead's ambrisentan improves 6MWD in PH patients

19 May 2009

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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