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J Am Coll Cardiol, 2005; 46:529-535, doi:10.1016/j.jacc.2005.04.050 (Published online 14 July 2005).
© 2005 by the American College of Cardiology Foundation
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Ambrisentan Therapy for Pulmonary Arterial Hypertension

Nazzareno Galié, MD*,*, David Badesch, MD{dagger}, Ronald Oudiz, MD{ddagger}, Gérald Simonneau, MD§, Michael D. McGoon, MD||, Anne M. Keogh, MD, Adaani E. Frost, MD#, Diane Zwicke, MD**, Robert Naeije, MD{dagger}{dagger}, Shelley Shapiro, MD, PhD{ddagger}{ddagger}, Horst Olschewski, MD§§ and Lewis J. Rubin, MD||||

* University of Bologna, Bologna, Italy
{dagger} University of Colorado Health Science Center, Denver, Colorado
{ddagger} Los Angeles Biomedical Research Institute at Harbor-UCLA, Torrance, California
§ Hôpital Antoine Béclère, Clamart, France
|| Mayo Clinic College of Medicine, Rochester, Minnesota
Saint Vincent’s Hospital, Darlinghurst, Australia
# Baylor College of Medicine and the Methodist Hospital, Houston, Texas
** St. Luke’s/Aurora Sinai Medical Centers, University of Wisconsin Medical School-Milwaukee Clinical Campus, Milwaukee, Wisconsin
{dagger}{dagger} Erasmus University, Brussels, Belgium
{ddagger}{ddagger} University of Southern California, Keck School of Medicine, Los Angeles, California
§§ University Giessen Lung Center, Giessen, Germany
|||| University of California-San Diego, San Diego, California



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Figure 1 The study design. Subjects randomized to the 5-mg dose group received 2.5 mg for 2 weeks and 5 mg for 10 weeks. Subjects randomized to the 10-mg dose group received 2.5 mg for 2 weeks, 5 mg for 2 weeks, and 10 mg for 8 weeks. Dose adjustments were allowed during the optional open-label extension period (weeks 13 to 24).

 


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Figure 2 (A) Mean change from baseline in 6-min walk distance (6MWD) for all patients at week 12 for the 1-, 2.5-, 5-, and 10-mg-dose groups and for all dose groups combined. (B) Mean change from baseline in 6MWD for idiopathic pulmonary arterial hypertension patients at week 12 for the 1-, 2.5-, 5-, and 10-mg-dose groups and for all dose groups combined. (C) Mean change from baseline in 6MWD for patients with pulmonary arterial hypertension associated with collagen vascular disease, anorexigen use, or human immunodeficiency virus infection at week 12 for the 1-, 2.5-, 5-, and 10-mg-dose groups and for all dose groups combined. *p < 0.02, {dagger}p < 0.001, {ddagger}p < 0.03.

 


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Figure 3 Mean change from baseline in 6-min walk distance (6MWD) for all dose group combined (n = 64) up to 24 weeks. Error bars indicate standard error of the mean. *p < 0.001.

 


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Figure 4 Change from baseline in World Health Organization functional class for all dose groups combined of ambrisentan up to 24 weeks. Higher classes indicate a greater severity of disease. Black bars = class I; ruled bars = class II; open bars = class III.

 




 
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