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Hemodynamic and clinical effects of tezosentan, an intravenous dual endothelin receptor antagonist, in patients hospitalized for acute decompensated heart failure

Guillermo Torre-Amione, MD^*,*, James B. Young, MD, Wilson S. Colucci, MD, Basil S. Lewis, MD, Craig Pratt, MD^*, Gad Cotter, MD^||, Karl Stangl, MD^¶, Uri Elkayam, MD^#, John R. Teerlink, MD^**, Aline Frey, PharmD, Maurizio Rainisio, PhD and Isaac Kobrin, MD

^* Methodist DeBakey Heart Center and Baylor College of Medicine, Houston, Texas, USA
Section on Heart Failure and Cardiac Transplant Medicine, The Cleveland Clinic Foundation, Cleveland, Ohio, USA
Cardiovascular Section, Boston Medical Center, Boston University School of Medicine, Boston, Massachusetts, USA
Cardiology Department, Lady Davis Carmel Medical Center, Haifa, Israel
^|| Cardiology Institute, Assaf-Harofeh Medical Center, Zerifin, Israel
^¶ Department of Cardiology, Charite Hospital, Humboldt University, Berlin, Germany
^# Division of Cardiology, University of Southern California School of Medicine, Los Angeles, California, USA
^** Cardiology, San Francisco Veterans Affairs Medical Center/University of California at San Francisco, San Francisco, California, USA
Actelion Pharmaceuticals Ltd., Allschwil, Switzerland

View larger version (17K): [in a new window]   Figure 1 Cardiac index: change from baseline to 6 h after treatment cessation (mean ± SE). Triangles = placebo group (n = 94); open circles = 50 mg/h tezosentan (n = 90); solid circles = 100 mg/h tezosentan (n = 101).

View larger version (32K): [in a new window]   Figure 2 Change from baseline to hour 6 of infusion in (A) pulmonary capillary wedge pressure (PCWP), mean pulmonary artery pressure (PAP), and mean right atrial pressure (RAP) and (B) pulmonary vascular resistance (PVR) and systemic vascular resistance (SVR) (means, 95% confidence limit [CL]). Confidence limits not crossing zero represent a significant change from baseline at p < 0.05. Dashed lines = placebo; solid lines = tezosentan (T).

View larger version (38K): [in a new window]   Figure 3 Percent of patients with markedly or moderately improved (scores 1 to 2) or worsened (scores 6 to 8) dyspnea after 24-h infusion.

View larger version (18K): [in a new window]   Figure 4 Kaplan-Meier plot of time to the combined end point of death or worsening heart failure (HF) during 24-h infusion.

View larger version (14K): [in a new window]   Figure 5 Kaplan-Meier plot of time to death, cardiac failure, pulmonary edema, or cardiogenic shock during treatment and up to 28 days after the end of treatment.