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Clinical effects of...
Clinical effects of endothelin receptor antagonism with bosentan in patients with severe chronic heart failure: results of a pilot study
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Packer, M. (author)
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McMurray, J. (author)
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Massie, B. M. (author)
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Caspi, A. (author)
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Charlon, V. (author)
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Cohen-Solal, A. (author)
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Kiowski, W. (author)
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Kostuk, W. (author)
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Krum, H. (author)
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Levine, B. (author)
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Rizzon, P. (author)
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Soler, J. (author)
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- Swedberg, Karl, 1944 (author)
- Gothenburg University,Göteborgs universitet,Hjärt-kärlinstitutionen,Cardiovascular Institute
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Anderson, S. (author)
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Demets, D. L. (author)
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(creator_code:org_t)
- Elsevier BV, 2005
- 2005
- English.
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In: Journal of cardiac failure. - : Elsevier BV. - 1071-9164. ; 11:1, s. 12-20
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https://gup.ub.gu.se...
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https://doi.org/10.1...
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Abstract
Subject headings
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- BACKGROUND: Endothelin receptor antagonism produces favorable short-term hemodynamic effects in heart failure, but the clinical effects of longer term therapy have not been evaluated. METHODS AND RESULTS: Three hundred and seventy patients with symptoms of heart failure at rest or on minimal exertion and a left ventricular ejection fraction <35% were randomly assigned (double-blind) to placebo (n = 126) or the endothelin receptor antagonist bosentan, titrated slowly (n = 121) or rapidly (n = 123) to a target dose of 500 mg twice daily. Treatment with the study drug was to be maintained for 26 weeks, whereas background medications for heart failure were kept constant. Safety concerns led to early termination of the trial when only 174 patients had had an opportunity to complete 26 weeks of therapy. Bosentan exerted no apparent benefit when all randomized patients were analyzed (P = .709). However, in the first 174 patients who were recruited at least 26 weeks before study termination and who could therefore be followed for the planned duration of the trial, patients in the bosentan groups were more likely to be improved (26% versus 19%) and were less likely to be worse (28% versus 43%), P = .045. When compared with placebo-treated patients, bosentan-treated patients had a increased risk of heart failure during the first month of treatment but a decreased risk of heart failure during the fourth, fifth, and sixth months of therapy. The major noncardiac adverse effects of bosentan included an increase in hepatic transaminases (in 15.6% of patients) and a decrease in hemoglobin (of about 1 g/L). CONCLUSION: Although bosentan exerted no favorable effects in the overall study, our findings suggest that the clinical responses to endothelin antagonism with bosentan in patients with severe chronic heart failure may be dependent on the duration of treatment.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
Keyword
- Aged
- Antihypertensive Agents/administration & dosage/pharmacology/*therapeutic
- use
- Double-Blind Method
- Erythrocyte Count
- Female
- Heart Failure
- Congestive/drug therapy/mortality/physiopathology
- Hemoglobins/analysis
- Hospitalization
- Humans
- Male
- Middle Aged
- Sulfonamides/administration & dosage/pharmacology/*therapeutic use
- Survival Analysis
- Treatment Failure
Publication and Content Type
- ref (subject category)
- art (subject category)
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To the university's database
- By the author/editor
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Packer, M.
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McMurray, J.
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Massie, B. M.
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Caspi, A.
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Charlon, V.
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Cohen-Solal, A.
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show more...
-
Kiowski, W.
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Kostuk, W.
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Krum, H.
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Levine, B.
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Rizzon, P.
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Soler, J.
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Swedberg, Karl, ...
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Anderson, S.
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Demets, D. L.
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cardiac and Card ...
- Articles in the publication
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Journal of cardi ...
- By the university
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University of Gothenburg