NEJM publishes AMBITION study of Volibris (ambrisentan) + Adcirca (tadalafil) for PAH- GSK, Gilead + Eli Lilly
The AMBITION study was a randomised, double-blind Phase IIIb/IV study designed to compare the efficacy and safety of Volibris (ambrisentan) from GSK/Gilead in combination with Adcirca (tadalafil) from Eli Lilly to monotherapy in treatment-naïve patients with WHO/NYHA functional class II and III PAH.
In the study, 500 patients were randomised (2:1:1) to receive ambrisentan and tadalafil combination (n=253) or monotherapy with ambrisentan (n=126) or tadalafil (n=121) (titrated from 5 mg to 10 mg once-daily and from 20 mg to 40 mg once-daily for ambrisentan and tadalafil, respectively).
Conclusions: Among participants with pulmonary arterial hypertension who had not received previous treatment, initial combination therapy with ambrisentan and tadalafil resulted in a significantly lower risk of clinical-failure events than the risk with ambrisentan or tadalafil monotherapy.
The AMBITION study was co-sponsored by GSK and Gilead. Eli Lilly and Company also provided funding and tadalafil drug supply for the study.
See: "Initial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension." Gali N., Barber J.A., Frost A.E., et al. N Engl J Med 2015; 373:834-844.
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