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Phase 3 Trials Find Ambrisentan is Safe and Effective for Patients With Pulmonary Arterial Hypertension: Presented at ATS

By Suzette Smiley-Jewell

SAN FRANCISCO, CA -- May 30, 2007 -- The vasodilator drug ambrisentan was found to be safe and effective for patients with pulmonary arterial hypertension in a pooled analysis of 2 phase 3 trials, researchers reported here at the American Thoracic Society 2007 International Conference.

The results come from the combination of the Ambrisentan in Pulmonary Arterial Hypertension, Randomized, Double-blind, Placebo-controlled, Multicenter, Efficacy Studies (ARIES-1 and ARIES-2), which began in 2004 and ended in 2006. Both studies were lasted for 12 weeks.

Lead author Nazzareno Galič, MD, associate professor of cardiology, faculty of medicine, University of Bologna, and head, Pulmonary Hypertension Centre, Institute of Cardiology, Bologna, Italy, discussed the results of the analysis in a poster presentation.

Pulmonary arterial hypertension is characterised by a higher than normal blood pressure in the pulmonary artery (greater than 25 mm Hg). The high blood pressure stresses the heart and lungs and can lead to premature death. Ambrisentan helps treat pulmonary arterial hypertension by dilating blood vessels, blocking the binding site of the endothelin receptor-A, which normally would cause narrowing of the blood vessels when binding endothelin.

The pooled analysis included 394 patients who were randomised to receive either placebo or ambrisentan at a dose of 2.5 mg, 5 mg, or 10 mg.

Results showed that patients were found to have marked improvement in physical activity as measured by 6-minute walk distance that increased with increasing ambrisentan dose. Furthermore, ambrisentan improved patients' quality of life by decreasing dyspnoea, and decreased cardiovascular risk, as indicated by lower levels of B-type natriuretic peptide.

Ambrisentan was well tolerated, and there were no signs of liver damage as compared to the placebo group.

Dr. Galič said that the most common adverse effects with the drug were mild to moderate peripheral oedema, headache, and upper respiratory tract infection. The only adverse effect that was dose related was nasal congestion, he said.


[Presentation title: Ambrisentan Therapy for Pulmonary Arterial Hypertension: An Integrated Analysis of ARIES-1 and ARIES-2 Studies. Poster 3192]

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