Serveur d'exploration sur les relations entre la France et l'Australie

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Bosentan therapy for pulmonary arterial hypertension

Identifieur interne : 00B812 ( Main/Exploration ); précédent : 00B811; suivant : 00B813

Bosentan therapy for pulmonary arterial hypertension

Auteurs : Lewis J. Rubin [États-Unis] ; David B. Badesch [États-Unis] ; Robyn J. Barst [États-Unis] ; Nazzareno Galie [Italie] ; Carol M. Black [Royaume-Uni] ; Anne Keogh [Australie] ; Tomas Pulido [Mexique] ; Adaani Frost [États-Unis] ; Sébastien Roux [Suisse] ; Isabelle Leconte [Suisse] ; Michael Landzberg [États-Unis] ; Gérald Simonneau [France]

Source :

RBID : Pascal:02-0231193

Descripteurs français

English descriptors

Abstract

Background Endothelin-1 is a potent vasoconstrictor and smooth-muscle mitogen. In a preliminary study, the orally administered dual endothelin-receptor antagonist bosentan improved exercise capacity and cardiopulmonary hemodynamics in patients with pulmonary arterial hypertension. The present trial investigated the effect of bosentan on exercise capacity in a larger number of patients and compared two doses. Methods In this double-blind, placebo-controlled study, we randomly assigned 213 patients with pulmonary arterial hypertension (primary or associated with connective-tissue disease) to receive placebo or to receive 6.25 mg of bosentan twice daily for 4 weeks followed by either of two doses of bosentan (125 or 250 mg twice daily) for a minimum of 12 weeks. The primary end point was the degree of change in exercise capacity. Secondary end points included the change in the Borg dyspnea index, the change in the World Health Organization (WHO) functional class, and the time to clinical worsening. Results At week 16, patients treated with bosentan had an improved six-minute walking distance; the mean difference between the placebo group and the combined bosentan groups was 44 m (95 percent confidence interval, 21 to 67; P<0.001). Bosentan also improved the Borg dyspnea index and WHO functional class and increased the time to clinical worsening. Conclusions The endothelin-receptor antagonist bosentan is beneficial in patients with pulmonary arterial hypertension and is well tolerated at a dose of 125 mg twice daily. Endothelin-receptor antagonism with oral bosentan is an effective approach to therapy for pulmonary arterial hypertension.


Affiliations:


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Le document en format XML

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<name sortKey="Simonneau, Gerald" sort="Simonneau, Gerald" uniqKey="Simonneau G" first="Gérald" last="Simonneau">Gérald Simonneau</name>
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<title level="j" type="main">The New England journal of medicine</title>
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<keywords scheme="KwdEn" xml:lang="en">
<term>Antagonist</term>
<term>Bosentan</term>
<term>Chemotherapy</term>
<term>Endothelin receptor</term>
<term>Human</term>
<term>Oral administration</term>
<term>Pulmonary hypertension</term>
<term>Treatment</term>
<term>Treatment efficiency</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Hypertension artérielle pulmonaire</term>
<term>Bosentan</term>
<term>Antagoniste</term>
<term>Récepteur endothéline</term>
<term>Chimiothérapie</term>
<term>Traitement</term>
<term>Homme</term>
<term>Voie orale</term>
<term>Efficacité traitement</term>
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<div type="abstract" xml:lang="en">Background Endothelin-1 is a potent vasoconstrictor and smooth-muscle mitogen. In a preliminary study, the orally administered dual endothelin-receptor antagonist bosentan improved exercise capacity and cardiopulmonary hemodynamics in patients with pulmonary arterial hypertension. The present trial investigated the effect of bosentan on exercise capacity in a larger number of patients and compared two doses. Methods In this double-blind, placebo-controlled study, we randomly assigned 213 patients with pulmonary arterial hypertension (primary or associated with connective-tissue disease) to receive placebo or to receive 6.25 mg of bosentan twice daily for 4 weeks followed by either of two doses of bosentan (125 or 250 mg twice daily) for a minimum of 12 weeks. The primary end point was the degree of change in exercise capacity. Secondary end points included the change in the Borg dyspnea index, the change in the World Health Organization (WHO) functional class, and the time to clinical worsening. Results At week 16, patients treated with bosentan had an improved six-minute walking distance; the mean difference between the placebo group and the combined bosentan groups was 44 m (95 percent confidence interval, 21 to 67; P<0.001). Bosentan also improved the Borg dyspnea index and WHO functional class and increased the time to clinical worsening. Conclusions The endothelin-receptor antagonist bosentan is beneficial in patients with pulmonary arterial hypertension and is well tolerated at a dose of 125 mg twice daily. Endothelin-receptor antagonism with oral bosentan is an effective approach to therapy for pulmonary arterial hypertension.</div>
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