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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

View larger version (16K): [in a new window]   Figure 1 Change in 6-min walking distance from baseline to week 6 and week 12 in the placebo and beraprost groups. Values are expressed as mean ± standard error. p = 0.036 for no difference between treatment groups with analysis of covariance at week 12.

View larger version (14K): [in a new window]   Figure 2 Mean change from baseline in results of the 6-min walk test at week 12 in all patients (ALL), in patients with primary pulmonary hypertension (PPH) and in patients with associated forms of pulmonary hypertension (APH). Analysis of covariance adjusted by baseline values showed that the mean distance walked in 6 min increased in patients who received beraprost (solid bars) compared with patients who received placebo (open bars) in ALL (p = 0.036) and in PPH patients (p = 0.035). No statistically significant changes were observed in APH patients (p = 0.676). Numbers at the tops of the bars = exact mean rates; lines = standard error of the mean. N = the number of patients in each group.

View larger version (13K): [in a new window]   Figure 3 Mean change in Borg dyspnea index from baseline to week 12 in all patients (ALL), in patients with primary pulmonary hypertension (PPH) and in patients with associated forms of pulmonary hypertension (APH). Analysis of covariance adjusted by baseline values showed that Borg dyspnea index improved (decreased) in patients who received beraprost (solid bars) and worsened (increased) in the placebo group (open bars) over 12 weeks in ALL (p = 0.009) and in PPH patients (p = 0.013). No statistically significant changes were observed in APH patients (p = 0.935). Numbers at the tops of the bars = exact mean rates; lines = standard error of the mean. N = the number of patients in each group.