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Ambrisentan Shows Long-Term Efficacy in Treatment of Pulmonary Hypertension: Presented at CHEST

By Em Brown

PHILADELPHIA, Penn -- October 29, 2008 -- Ambrisentan, a selective endothelin receptor antagonist, has been shown to be effective and safe and to improve survival rates in patients with pulmonary arterial hypertension (PAH), according to 2-year results of an ongoing extension study.

The 2-year extension-phase Ambrisentan in Pulmonary Arterial Hypertension, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Studies 1 and 2 (ARIES-E) were reported here by principal investigator Ronald J. Oudiz, MD, David Geffen School of Medicine, University of California, Los Angeles, California.

The analysis involved 383 patients with PAH and World Health Organisation class II or class III symptoms who received at least 1 dose of ambrisentan 2.5 mg, 5 mg, or 10 mg QD. This included patients treated with placebo in ARIES-1 or ARIES-2 who were randomised in ARIES-E to ambrisentan 5 mg QD or 10 mg QD. These dosages have received approval from the U.S. Food and Drug Administration for PAH.

At 2 years, 82% of patients remained on ambrisentan monotherapy and 100 had discontinued treatment owing to death, adverse events, or other reasons.

Patients had mean improvements from baseline in 6-minute walk test distance (6MWTD) of 34.6 m with 5 mg QD and 37.5 m with 10 mg QD at 12 weeks. Mean improvements were 23.2 m and 28.0 m, respectively, at 2 years.

Clinical worsening was defined as death, lung transplantation, PAH hospitalisation, atrial septostomy, addition of prostanoid therapy, or study withdrawal because of the addition of other PAH drugs.

The probability of no clinical worsening at 2 years was 72%. Survival at 2 years was 88%.

"This is the first time [that] prospectively collected 2-year clinical trial, safety, and efficacy data have been presented evaluating an endothelin receptor antagonist therapy in PAH," Dr. Oudiz said on October 28.

"As a chronic, progressive disease, it is important that PAH therapies are evaluated over the long term to better characterise safety and efficacy," he added.

"As study ARIES-E is uncontrolled, these findings do not allow for comparison with a group not given ambrisentan and cannot be used to definitively determine the long-term effect of ambrisentan on survival," he cautioned.


[Presentation title: Ambrisentan Therapy in Patients With Pulmonary Arterial Hypertension: 2-Year Outcome. Abstract AS2244]

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