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Clinical Trial
. 2010 Feb;16(2):121-7.
doi: 10.1016/j.cardfail.2009.09.008. Epub 2009 Nov 20.

Long-term outcomes with ambrisentan monotherapy in pulmonary arterial hypertension

Shannon E Blalock  1 , Susan Matulevicius, Laura C Mitchell, Sharon Reimold, John Warner, Ronald Peshock, Fernando Torres, Kelly M Chin
Affiliations
Clinical Trial

Long-term outcomes with ambrisentan monotherapy in pulmonary arterial hypertension

Shannon E Blalock et al. J Card Fail. 2010 Feb.

Abstract

Background: This study evaluated long-term outcomes in patients with pulmonary arterial hypertension (PAH) undergoing treatment with ambrisentan monotherapy, a selective oral endothelin-1 receptor antagonist.

Methods and results: Patients who participated in the Ambrisentan in Pulmonary Arterial Hypertension: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Efficacy Study (ARIES-1) clinical trial and extension phase at our institution were included. Cardiac catheterization, 6-minute walk distance (6MWD), and cardiac magnetic resonance (MRI) data were retrospectively reviewed. Twelve patients with PAH (11 idiopathic, 1 fenfluramine) had follow-up from 3 to 5.5 years from the initiation of ARIES-1. Patients received ambrisentan therapy throughout the study period and were on ambrisentan monotherapy for the first 2 years. At year 1, improvements in median mean pulmonary arterial pressure (PA), cardiac output, and pulmonary vascular resistance (PVR) were seen (P = .02, P = .03, P < .01), and the improvement in PVR persisted at 2 years. 6MWD also improved significantly between baseline (350 m) and 1 and 2 years (397 m, P < .01 and 393 m, P = .01). Cardiac MRI results were more varied, with an increase in RV ejection fraction from 29% at baseline to 46% at 2 years (P = .02), but other MRI variables did not improve.

Conclusions: Ambrisentan monotherapy led to improvements in catheterization, 6MWD, and RV ejection fraction, and shows promise as a long-term treatment for pulmonary arterial hypertension.

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Figures

Figure 1
Figure 1. Flow chart
Fourteen patients at our institution enrolled in ARIES-1 trial. Twelve were included in the long-term open label trial
Figure 2
Figure 2. Cardiac MRI
Four-chamber views of the heart by cardiac MRI. A) Dilated right ventricle (RV) in patient with RV end-diastolic volume of 600ml (patient 5) and B) Normal right ventricle in patient with RV end-diastolic volume of 150 ml (patient 3)
Figure 3
Figure 3
Figure 4
Figure 4
Survival
See this image and copyright information in PMC

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