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Delaying ambrisentan has lasting effect on walk test.

San Diego--In patients with pulmonary arterial hypertension, a short delay in starting endothelin receptor antagonist therapy with ambrisentan proved to have long-lasting deleterious consequences in the ARIES-E trial.

A total of 100 ARIES-E participants who received ambrisentan (Letairis) after completing 12 weeks of double-blind placebo responded with a less robust improvement in exercise capacity during 2 years of follow-up than did 197 patients on ambrisentan from the start. The group on placebo before ambrisentan never caught up in terms of 6-minute walk distance, Dr. Aaron B. Waxman reported at the annual meeting of the American College of Chest Physicians.

At the 12-week mark in the double-blind ARIES-1 (Ambrisentan in Pulmonary Arterial Hypertension, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study) and ARIES-2 trials, patients on ambrisentan from the outset had a mean 42-m gain in 6-minute walk distance over their baseline of 345 m. Patients who received placebo before ambrisentan averaged a 1-m decline from baseline.

When assessed after 2 years of follow-up in ARIES-E (the extension study) patients who had been on ambrisentan from the start had a mean 30-m improvement in 6-minute walk distance, compared with baseline. Patients on placebo for 12 weeks before receiving ambrisentan had a mean 10-m improvement, according to Dr. Waxman of Massachusetts General Hospital, Boston.

The rate of clinical worsening at 1 year was 16% in the group on ambrisentan from the outset, compared with 24% in those who got placebo first.

By 2 years, however, the clinical worsening rate was similar in both groups, at about 30%.

Ambrisentan was well tolerated in ARIES-E, with mild to moderate peripheral edema the most common adverse event. Liver enzymes were elevated during 2 years of follow-up in seven patients on ambrisentan from the start and six patients on placebo followed by the endothelin receptor antagonist.

Disclosures: The ARIES trials were funded by Gilead Sciences, which manufactures Letairis. Dr. Waxman disclosed serving on advisory boards for Gilead and United Therapeutics.
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Author:Jancin, Bruce
Publication:Internal Medicine News
Geographic Code:1USA
Date:Mar 15, 2010
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