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GlaxoSmithKline’s Phase IIIb/IV combination trial for hypertension meets primary endpoint

GlaxoSmithKline (GSK) has reported results from the first Phase IIIb/IV trial of the combination therapy of ambrisentan and tadalafil to treat patients with pulmonary arterial hypertension (PAH).

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The randomized, double-blind, multicentre trial called AMBITION, conducted in collaboration with Gilead Sciences, met the primary endpoint by showing superiority of the combination therapy compared to monotherapy treatment (ambrisentan or tadalafil).

GSK Rare Diseases Research & Development head and senior vice-president Dr Carlo Russo said: "As part of our efforts to further help patients who suffer with this rare and debilitating lung disease, GSK and Gilead took a major step to jointly sponsor the first study to investigate whether there was an advantage to use upfront combination of ambrisentan and tadalafil compared to first-line monotherapy with either medicine."

The trial showed that first-line treatment of PAH with the combination of ambrisentan 10mg and tadalafil 40mg reduced the risk of clinical failure by 50% compared to pooled ambrisentan and tadalafil monotherapy arm.

The combination therapy was also statistically significant versus the individual ambrisentan and tadalafil monotherapy groups for the primary endpoint.

Statistically significant improvements were also observed for three of the secondary endpoints including six-minute walk distance test, percentage of patients with satisfactory clinical response and change from baseline in N-terminal pro-B-type natriuretic peptide.

The remaining two secondary endpoints which include WHO functional class and Borg dyspnea index did not meet statistical significance.

Currently, the companies are planning to submit data from the AMBITION trial to regulators in the US, European Union (EU) and the rest of the world, in order secure approval for the combination therapy.


Image: GlaxoSmithKline headquaters in London, UK. Photo: courtesy of Maxwell Hamilton.