Ambrisentan and Tadalafil combination success in AMBITION study for PAH - Gilead/GSK

Gilead Sciences, Inc. announced results from the AMBITION study (a randomized, double-blind, multicenter study of first-line combination therapy with Ambrisentan and Tadalafil in patients with pulmonary arterial hypertensION), which was conducted in collaboration with GlaxoSmithKline.

In AMBITION, first-line treatment of Pulmonary Arterial Hypertension (PAH) with the combination of ambrisentan 10 mg and tadalafil 40 mg reduced the risk of clinical failure by 50 percent compared to the pooled ambrisentan and tadalafil monotherapy arm (hazard ratio = 0.502; 95 percent CI: 0.348, 0.724; p=0.0002). The combination was also statistically significant versus the individual ambrisentan and tadalafil monotherapy groups for the primary endpoint (p<0.01). rates of serious adverse events and events leading to discontinuation were similar across treatment arms. detailed results from the study (abstract #2916) will be presented today during an oral session at ers international congress 2014, the annual meeting of the european respiratory society.>