CLINICAL STUDY: PULMONARY HYPERTENSION
Effects of beraprost sodium, an oral prostacyclin analogue, in patients with pulmonary arterial hypertension: a randomized, double-blind, placebo-controlled trial
Nazzareno Galiè, MD*,*,
Marc Humbert, MD ,
Jean-Luc Vachiéry, MD ,
CarmineDario Vizza, MD ,
Meinhard Kneussl, MD||,
Alessandra Manes, MD*,
Olivier Sitbon, MD,
Adam Torbicki, MD¶,
Marion Delcroix, MD#,
Robert Naeije, MD,
Marius Hoeper, MD**,
Ari Chaouat, MD,
Sophie Morand, MD,
Bruno Besse, MD,
Gerald Simonneau, MD the Arterial Pulmonary Hypertension and Beraprost European Trial (ALPHABET) Study Group
* Institute of Cardiology, University of Bologna, Bologna, Italy
Division of Pulmonary and Critical Care Medicine, Antoine Béclère Hospital, Clamart, Paris-Sud University, Clamart, France
Departement de Cardiologie et Laboratoire de Physiologie, Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium
Department of Cardiology, University of Roma "La Sapienza," Rome, Italy
|| Allgemeines Krankenhaus der Stadt Wien, University of Vienna, Vienna, Austria
¶ Department of Chest Medicine, National Institute of Tuberculosis and Lung Disease, Warsaw, Poland
# Department of Pneumology, Gasthuisberg University Hospital, Leuven, Belgium
** Abteilung Pneumologie, Medizinische Hochschule Hannover, Hannover, Germany
Service de Pneumologie, Centre Hospitalier Hautepierre, Strasbourg, France
Laboratoire Aventis, Paris, France
Manuscript received November 6, 2001;
revised manuscript received January 28, 2002,
accepted February 6, 2002.
* Reprint requests and correspondence: Dr. Nazzareno Galiè, Istituto di Cardiologia, Università di Bologna, via Massarenti, 9, 40138-Bologna, Italy.
n.galie{at}bo.nettuno.it
OBJECTIVES: The purpose of this study was to assess the efficacy and safety of beraprost sodium, an orally active prostacyclin analogue, in New York Heart Association (NYHA) functional class II and III patients with pulmonary arterial hypertension (PAH).
BACKGROUND: Pulmonary arterial hypertension is a life-threatening disease for which continuous intravenous infusion of prostacyclin has been proven effective. However, this treatment is associated with serious complications arising from the complex delivery system.
METHODS: In this double-blind, placebo-controlled study, 130 patients with PAH were randomized to the maximal tolerated dose of beraprost (median dose 80 µg four times a day) or to placebo for 12 weeks. The primary end point was the change in exercise capacity assessed by the 6-min walk test. Secondary end points included changes in Borg dyspnea index, cardiopulmonary hemodynamics and NYHA functional class.
RESULTS: Patients treated with beraprost improved exercise capacity and symptoms. The difference between treatment groups in the mean change of 6-min walking distance at week 12 was 25.1 m (95% confidence interval [CI]: 1.8 to 48.3, p = 0.036). The difference in the mean change of Borg dyspnea index was –0.94 (95% CI: –1.63 to –0.24, p = 0.009). In the sub-group of patients with primary pulmonary hypertension, the difference in the mean change of 6-min walking distance was 46.1 m (95% CI: 3.0 to 89.3, p = 0.035). Cardiopulmonary hemodynamics and NYHA functional class had no statistically significant changes. Drug-related adverse events were common in the titration phase and decreased in the maintenance period.
CONCLUSIONS: Beraprost improves exercise capacity and symptoms in NYHA functional class II and III patients with PAH and, in particular, in those with primary pulmonary hypertension.
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Abbreviations and Acronyms
| | CI | | confidence interval | | HIV | | human immunodeficiency virus | | PAH | | pulmonary arterial hypertension | | NYHA | | New York Heart Association |
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