Hemodynamic and clinical effects of tezosentan, an intravenous dual endothelin receptor antagonist, in patients hospitalized for acute decompensated heart failure
OBJECTIVES: We sought to investigate the efficacy and safety of tezosentan, a dual endothelin receptor antagonist, in patients hospitalized for acute heart failure (HF).
BACKGROUND: Tezosentan has been previously shown to improve hemodynamics in patients with stable chronic HF.
METHODS: In a double-blind fashion, 292 patients (cardiac index < or =2.5 l/min per m(2) and pulmonary capillary wedge pressure (PCWP) > or =15 mm Hg) who were admitted to the hospital and in need of intravenous treatment for acute HF and central hemodynamic monitoring were randomized to 24-h intravenous treatment with tezosentan (50 or 100 mg/h) or placebo. Central hemodynamic variables, the dyspnea score, and safety variables were measured.
RESULTS: After 6 h of treatment, significantly greater increases in the cardiac index and decreases in PCWP were observed with both tezosentan dosages than with placebo (mean treatment effects at 0.38 and 0.37 l/min per m(2) with 50 and 100 mg/h and -3.9 mm Hg for each dose, respectively; p < 0.0001). This effect was maintained during the remaining infusion and for > or =6 h after treatment cessation. A tendency for an improved dyspnea score and a decreased risk of clinical worsening was observed after 24 h of treatment with each tezosentan dose. Adverse events, more frequent with tezosentan than with placebo (headache, asymptomatic hypotension, early worsening of renal function, nausea, vomiting), were dose-related.
CONCLUSIONS: Intravenous tezosentan rapidly and effectively improved hemodynamics in these patients. The similar beneficial effects of the two dosages and the increased dose-related adverse events with the higher dosage suggest that the optimal dosing regimen is <50 mg/h.
Medienart: |
Artikel |
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Erscheinungsjahr: |
2003 |
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Erschienen: |
2003 |
Enthalten in: |
Zur Gesamtaufnahme - volume:42 |
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Enthalten in: |
Journal of the American College of Cardiology - 42(2003), 1 vom: 02. Juli, Seite 140-7 |
Sprache: |
Englisch |
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Beteiligte Personen: |
Torre-Amione, Guillermo [VerfasserIn] |
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Themen: |
64J9J55263 |
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Anmerkungen: |
Date Completed 06.08.2003 Date Revised 08.07.2019 published: Print Citation Status MEDLINE |
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Förderinstitution / Projekttitel: |
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PPN (Katalog-ID): |
NLM126101817 |
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041 | |a eng | ||
100 | 1 | |a Torre-Amione, Guillermo |e verfasserin |4 aut | |
245 | 1 | 0 | |a Hemodynamic and clinical effects of tezosentan, an intravenous dual endothelin receptor antagonist, in patients hospitalized for acute decompensated heart failure |
264 | 1 | |c 2003 | |
336 | |a Text |b txt |2 rdacontent | ||
337 | |a ohne Hilfsmittel zu benutzen |b n |2 rdamedia | ||
338 | |a Band |b nc |2 rdacarrier | ||
500 | |a Date Completed 06.08.2003 | ||
500 | |a Date Revised 08.07.2019 | ||
500 | |a published: Print | ||
500 | |a Citation Status MEDLINE | ||
520 | |a OBJECTIVES: We sought to investigate the efficacy and safety of tezosentan, a dual endothelin receptor antagonist, in patients hospitalized for acute heart failure (HF) | ||
520 | |a BACKGROUND: Tezosentan has been previously shown to improve hemodynamics in patients with stable chronic HF | ||
520 | |a METHODS: In a double-blind fashion, 292 patients (cardiac index < or =2.5 l/min per m(2) and pulmonary capillary wedge pressure (PCWP) > or =15 mm Hg) who were admitted to the hospital and in need of intravenous treatment for acute HF and central hemodynamic monitoring were randomized to 24-h intravenous treatment with tezosentan (50 or 100 mg/h) or placebo. Central hemodynamic variables, the dyspnea score, and safety variables were measured | ||
520 | |a RESULTS: After 6 h of treatment, significantly greater increases in the cardiac index and decreases in PCWP were observed with both tezosentan dosages than with placebo (mean treatment effects at 0.38 and 0.37 l/min per m(2) with 50 and 100 mg/h and -3.9 mm Hg for each dose, respectively; p < 0.0001). This effect was maintained during the remaining infusion and for > or =6 h after treatment cessation. A tendency for an improved dyspnea score and a decreased risk of clinical worsening was observed after 24 h of treatment with each tezosentan dose. Adverse events, more frequent with tezosentan than with placebo (headache, asymptomatic hypotension, early worsening of renal function, nausea, vomiting), were dose-related | ||
520 | |a CONCLUSIONS: Intravenous tezosentan rapidly and effectively improved hemodynamics in these patients. The similar beneficial effects of the two dosages and the increased dose-related adverse events with the higher dosage suggest that the optimal dosing regimen is <50 mg/h | ||
650 | 4 | |a Clinical Trial | |
650 | 4 | |a Journal Article | |
650 | 4 | |a Multicenter Study | |
650 | 4 | |a Randomized Controlled Trial | |
650 | 4 | |a Research Support, Non-U.S. Gov't | |
650 | 7 | |a Endothelin Receptor Antagonists |2 NLM | |
650 | 7 | |a Pyridines |2 NLM | |
650 | 7 | |a Tetrazoles |2 NLM | |
650 | 7 | |a tezosentan |2 NLM | |
650 | 7 | |a 64J9J55263 |2 NLM | |
700 | 1 | |a Young, James B |e verfasserin |4 aut | |
700 | 1 | |a Colucci, Wilson S |e verfasserin |4 aut | |
700 | 1 | |a Lewis, Basil S |e verfasserin |4 aut | |
700 | 1 | |a Pratt, Craig |e verfasserin |4 aut | |
700 | 1 | |a Cotter, Gad |e verfasserin |4 aut | |
700 | 1 | |a Stangl, Karl |e verfasserin |4 aut | |
700 | 1 | |a Elkayam, Uri |e verfasserin |4 aut | |
700 | 1 | |a Teerlink, John R |e verfasserin |4 aut | |
700 | 1 | |a Frey, Aline |e verfasserin |4 aut | |
700 | 1 | |a Rainisio, Maurizio |e verfasserin |4 aut | |
700 | 1 | |a Kobrin, Isaac |e verfasserin |4 aut | |
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