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J Am Coll Cardiol, 2003; 41:1380-1386, doi:10.1016/S0735-1097(03)00121-9
© 2003 by the American College of Cardiology Foundation
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CLINICAL STUDY: SYSTEMIC AND PULMONARY HYPERTENSION

Effects of the oral endothelin-receptorantagonist bosentan on echocardiographicand doppler measures in patients with pulmonary arterial hypertension

Nazzareno Galiè, MD*,*, Alan L. Hinderliter, MD{dagger}, Adam Torbicki, MD{ddagger}, Thierry Fourme, MD§, Gerald Simonneau, MD§, Tomas Pulido, MD||, Nilda Espinola-Zavaleta, MD||, Guido Rocchi, MD*, Alessandra Manes, MD*, Robert Frantz, MD, Marcin Kurzyna, MD{ddagger}, Sherif F. Nagueh, MD#, Robyn Barst, MD**, Richard Channick, MD{dagger}{dagger}, Karl Dujardin, MD{ddagger}{ddagger}, Andrew Kronenberg, MD{dagger}, Isabelle Leconte, PhD§§, Maurizio Rainisio, PhD§§ and Lewis Rubin, MD{dagger}{dagger}

* Institute of Cardiology, University of Bologna, Italy
{dagger} Department of Medicine, University of North Carolina, Chapel Hill, North Carolina, USA
{ddagger} Department of Chest Medicine, Institute of Tuberculosis and Lung Disease, Warsaw, Poland
§ Division of Pulmonary and Critical Care Medicine, University of Paris-Sud, Paris, France
|| Instituto Nacional de Cardiologia, Mexico City, Mexico
Department of Cardiology, Mayo Clinic, Rochester, Minnesota, USA
# Baylor College of Medicine and the Methodist Hospital, Houston, Texas, USA
** Department of Pediatrics, Columbia University College of Physicians and Surgeons, New York, New York, USA
{dagger}{dagger} Division of Pulmonary and Critical Care Medicine, University of California, San Diego, California, USA
{ddagger}{ddagger} Department of Cardiology, Gasthuisberg University Hospital, Leuven, Belgium
§§ Actelion Ltd., Allschwil, Switzerland

Manuscript received August 11, 2002; revised manuscript received December 20, 2002, accepted January 2, 2003.

* 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 investigate the effects of bosentan (125 or 250 mg twice daily) on echocardiographic and Doppler variables in 85 patients with World Health Organization class III or IV pulmonary arterial hypertension (PAH).

BACKGROUND: Bosentan, an orally active dual endothelin-receptor antagonist, improves symptoms, exercise capacity, and hemodynamics in patients with PAH.

METHODS: Patients had primary pulmonary hypertension (84%) or PAH associated with connective tissue disease. Of these, 29 patients received placebo and 56 received bosentan (1:2 randomization). Six-minute walk tests and echocardiograms were performed at baseline and after 16 weeks of treatment.

RESULTS: Baseline characteristics were similar in the placebo and bosentan groups, and echocardiographic and Doppler findings were consistent with marked abnormalities of right ventricular (RV) and left ventricular (LV) structure and function that were due to PAH. The treatment effect on 6-min walking distance was 37 m in favor of bosentan (p = 0.036). Treatment effects of bosentan compared with placebo on other parameters were as follows: Doppler-derived cardiac index = +0.4 l/min/m2 (p = 0.007), LV early diastolic filling velocity = +10.5 cm/s (p = 0.003), LV end-diastolic area = +4.2 cm2 (p = 0.003), LV systolic eccentricity index = –0.12 (p = 0.047), RV end-systolic area = –2.3 cm2 (p = 0.057), RV:LV diastolic areas ratio = –0.64 (p = 0.007), Doppler RV index = –0.06 (p = 0.03), and percentage of patients with an improvement in pericardial effusion score = 17% (p = 0.05).

CONCLUSIONS: Bosentan improves RV systolic function and LV early diastolic filling and leads to a decrease in RV dilation and an increase in LV size in patients with PAH.

Abbreviations and Acronyms
  BREATHE-1
  Bosentan Randomized trial of Endothelin Antagonist Therapy for pulmonary hypertension
  LV
  left ventricle/ventricular
  PAH
  pulmonary arterial hypertension
  PPH
  primary pulmonary hypertension
  RV
  right ventricle/ventricular
  WHO
  World Health Organization




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