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ARTICLE | Clinical News

Letairis: Phase IIIb/IV data

November 10, 2014 8:00 AM UTC

The double-blind, international Phase IIIb/IV AMBITION trial in 500 patients with PAH showed that first-line treatment with once-daily ambrisentan plus once-daily tadalafil met the primary endpoint of improving time to clinical failure vs. monotherapy treatment with ambrisentan or tadalafil. Specifically, the combination ambrisentan and tadalafil reduced the risk of clinical failure by 50% compared to the pooled ambrisentan and tadalafil monotherapy arms (p=0.0002). The combination also met the secondary endpoints of improving 6MWD, of a greater proportion of patients with a satisfactory clinical response and of improving NT-proBNP levels vs. monotherapy treatment, but missed the secondary endpoints of improving WHO Functional Class and Borg Dyspnea Index. Data were presented at the European Regulatory Society meeting in Munich. AMBITION was sponsored by Gilead and GlaxoSmithKline, while Eli Lilly and Co. (NYSE:LLY, Indianapolis, Ind.) provided funding and the supply of tadalafil for the trial. ...