AustralieFrV1, Main, Exploration, bibRecord, 00A763

Ambrisentan therapy for pulmonary arterial hypertension

Identifieur interne : 00A763 ( Main/Exploration ); précédent : 00A762; suivant : 00A764

Ambrisentan therapy for pulmonary arterial hypertension

Auteurs : Nazzareno Galie [Italie] ; David Badesch [États-Unis] ; Ronald Oudiz [États-Unis] ; Gérald Simonneau [France] ; Michael D. Mcgoon [États-Unis] ; Anne M. Keogh [Australie] ; Adaani E. Frost [États-Unis] ; Diane Zwicke [États-Unis] ; Robert Naeije [Belgique] ; Shelley Shapiro [États-Unis] ; Horst Olschewski [Allemagne] ; Lewis J. Rubin [États-Unis]

Source :

Journal of the American College of Cardiology [ 0735-1097 ] ; 2005.

RBID : Pascal:05-0351092

Descripteurs français

Pascal (Inist)
- Hypertension artérielle pulmonaire, Ambrisentan, Traitement, Artère, Appareil circulatoire, Cardiologie, Phlébologie.

English descriptors

KwdEn :
- Ambrisentan, Artery, Cardiology, Circulatory system, Phlebology, Pulmonary hypertension, Treatment.

Abstract

OBJECTIVES The purpose of this study was to examine the efficacy and safety of four doses of ambrisentan, an oral endothelin type A receptor-selective antagonist, in patients with pulmonary arterial hypertension (PAH). BACKGROUND Pulmonary arterial hypertension is a life-threatening and progressive disease with limited treatment options. Endothelin is a vasoconstrictor and smooth muscle cell mitogen that plays a critical role in the pathogenesis and progression of PAH. METHODS In this double-blind, dose-ranging study, 64 patients with idiopathic PAH or PAH associated with collagen vascular disease, anorexigen use, or human immunodeficiency virus infection were randomized to receive 1, 2.5, 5, or 10 mg of ambrisentan once daily for 12 weeks followed by 12 weeks of open-label ambrisentan. The primary end point was an improvement from baseline in 6-min walk distance (6MWD); secondary end points included Borg dyspnea index, World Health Organization (WHO) functional class, a subject global assessment, and cardiopulmonary hemodynamics. RESULTS At 12 weeks, ambrisentan increased 6MWD (+36.1 m, p < 0.0001) with similar and statistically significant increases for each dose group (range, +33.9 to +38.1 m). Improvements were also observed in Borg dyspnea index, WHO functional class, subject global assessment, mean pulmonary arterial pressure (-5.2 mm Hg, p < 0.0001), and cardiac index (+0.33 l/min/m², p < 0.0008). Adverse events were mild and unrelated to dose, including the incidence of elevated serum aminotransferase concentrations >3 times the upper limit of normal (3.1%). CONCLUSIONS Ambrisentan appears to improve exercise capacity, symptoms, and hemodynamics in patients with PAH. The incidence and severity of liver enzyme abnormalities appear to be low.

Affiliations:

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Le document en format XML

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<author><name sortKey="Keogh, Anne M" sort="Keogh, Anne M" uniqKey="Keogh A" first="Anne M." last="Keogh">Anne M. Keogh</name>
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<author><name sortKey="Frost, Adaani E" sort="Frost, Adaani E" uniqKey="Frost A" first="Adaani E." last="Frost">Adaani E. Frost</name>
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<author><name sortKey="Zwicke, Diane" sort="Zwicke, Diane" uniqKey="Zwicke D" first="Diane" last="Zwicke">Diane Zwicke</name>
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<author><name sortKey="Shapiro, Shelley" sort="Shapiro, Shelley" uniqKey="Shapiro S" first="Shelley" last="Shapiro">Shelley Shapiro</name>
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<country>Allemagne</country>
<wicri:noRegion>Giessen</wicri:noRegion>
<wicri:noRegion>University Giessen Lung Center</wicri:noRegion>
<wicri:noRegion>University Giessen Lung Center</wicri:noRegion>
</affiliation>
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<author><name sortKey="Rubin, Lewis J" sort="Rubin, Lewis J" uniqKey="Rubin L" first="Lewis J." last="Rubin">Lewis J. Rubin</name>
<affiliation wicri:level="2"><inist:fA14 i1="12"><s1>University of California-San Diego</s1>
<s2>San Diego, California</s2>
<s3>USA</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
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<series><title level="j" type="main">Journal of the American College of Cardiology</title>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Ambrisentan</term>
<term>Artery</term>
<term>Cardiology</term>
<term>Circulatory system</term>
<term>Phlebology</term>
<term>Pulmonary hypertension</term>
<term>Treatment</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Hypertension artérielle pulmonaire</term>
<term>Ambrisentan</term>
<term>Traitement</term>
<term>Artère</term>
<term>Appareil circulatoire</term>
<term>Cardiologie</term>
<term>Phlébologie</term>
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<front><div type="abstract" xml:lang="en">OBJECTIVES The purpose of this study was to examine the efficacy and safety of four doses of ambrisentan, an oral endothelin type A receptor-selective antagonist, in patients with pulmonary arterial hypertension (PAH). BACKGROUND Pulmonary arterial hypertension is a life-threatening and progressive disease with limited treatment options. Endothelin is a vasoconstrictor and smooth muscle cell mitogen that plays a critical role in the pathogenesis and progression of PAH. METHODS In this double-blind, dose-ranging study, 64 patients with idiopathic PAH or PAH associated with collagen vascular disease, anorexigen use, or human immunodeficiency virus infection were randomized to receive 1, 2.5, 5, or 10 mg of ambrisentan once daily for 12 weeks followed by 12 weeks of open-label ambrisentan. The primary end point was an improvement from baseline in 6-min walk distance (6MWD); secondary end points included Borg dyspnea index, World Health Organization (WHO) functional class, a subject global assessment, and cardiopulmonary hemodynamics. RESULTS At 12 weeks, ambrisentan increased 6MWD (+36.1 m, p < 0.0001) with similar and statistically significant increases for each dose group (range, +33.9 to +38.1 m). Improvements were also observed in Borg dyspnea index, WHO functional class, subject global assessment, mean pulmonary arterial pressure (-5.2 mm Hg, p < 0.0001), and cardiac index (+0.33 l/min/m<sup>2</sup>
, p < 0.0008). Adverse events were mild and unrelated to dose, including the incidence of elevated serum aminotransferase concentrations >3 times the upper limit of normal (3.1%). CONCLUSIONS Ambrisentan appears to improve exercise capacity, symptoms, and hemodynamics in patients with PAH. The incidence and severity of liver enzyme abnormalities appear to be low.</div>
</front>
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<li>Wisconsin</li>
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<tree><country name="Italie"><noRegion><name sortKey="Galie, Nazzareno" sort="Galie, Nazzareno" uniqKey="Galie N" first="Nazzareno" last="Galie">Nazzareno Galie</name>
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<name sortKey="Frost, Adaani E" sort="Frost, Adaani E" uniqKey="Frost A" first="Adaani E." last="Frost">Adaani E. Frost</name>
<name sortKey="Mcgoon, Michael D" sort="Mcgoon, Michael D" uniqKey="Mcgoon M" first="Michael D." last="Mcgoon">Michael D. Mcgoon</name>
<name sortKey="Oudiz, Ronald" sort="Oudiz, Ronald" uniqKey="Oudiz R" first="Ronald" last="Oudiz">Ronald Oudiz</name>
<name sortKey="Rubin, Lewis J" sort="Rubin, Lewis J" uniqKey="Rubin L" first="Lewis J." last="Rubin">Lewis J. Rubin</name>
<name sortKey="Shapiro, Shelley" sort="Shapiro, Shelley" uniqKey="Shapiro S" first="Shelley" last="Shapiro">Shelley Shapiro</name>
<name sortKey="Zwicke, Diane" sort="Zwicke, Diane" uniqKey="Zwicke D" first="Diane" last="Zwicke">Diane Zwicke</name>
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<country name="Australie"><noRegion><name sortKey="Keogh, Anne M" sort="Keogh, Anne M" uniqKey="Keogh A" first="Anne M." last="Keogh">Anne M. Keogh</name>
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<country name="Belgique"><region name="Région de Bruxelles-Capitale"><name sortKey="Naeije, Robert" sort="Naeije, Robert" uniqKey="Naeije R" first="Robert" last="Naeije">Robert Naeije</name>
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<country name="Allemagne"><noRegion><name sortKey="Olschewski, Horst" sort="Olschewski, Horst" uniqKey="Olschewski H" first="Horst" last="Olschewski">Horst Olschewski</name>
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Serveur d'exploration sur les relations entre la France et l'Australie

Ambrisentan therapy for pulmonary arterial hypertension

Ambrisentan therapy for pulmonary arterial hypertension

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