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Effect of carvedilol on survival in severe chronic heart failure

Identifieur interne : 00BD45 ( Main/Exploration ); précédent : 00BD44; suivant : 00BD46

Effect of carvedilol on survival in severe chronic heart failure

Auteurs : Milton Packer [États-Unis] ; Andrew J. S. Coats [Royaume-Uni] ; Michael B. Fowler [États-Unis] ; Hugo A. Katus [Allemagne] ; Henry Krum [Australie] ; Paul Mohacsi [Suisse] ; Jean L. Rouleau [États-Unis] ; Michal Tendera [Pologne] ; Alain Castaigne [France] ; Ellen B. Roecker [États-Unis] ; Melissa K. Schultz [États-Unis] ; David L. Demets [États-Unis]

Source :

RBID : Pascal:01-0304971

Descripteurs français

English descriptors

Abstract

Background Beta-blocking agents reduce the risk of hospitalization and death in patients with mild-to-moderate heart failure, but little is known about their effects in severe heart failure. Methods We evaluated 2289 patients who had symptoms of heart failure at rest or on minimal exertion, who were clinically euvolemic, and who had an ejection fraction of less than 25 percent. In a double-blind fashion, we randomly assigned 1133 patients to placebo and 1156 patients to treatment with carvedilol for a mean period of 10.4 months, during which standard therapy for heart failure was continued. Patients who required intensive care, had marked fluid retention, or were receiving intravenous vasodilators or positive inotropic drugs were excluded. Results There were 190 deaths in the placebo group and 130 deaths in the carvedilol group. This difference reflected a 35 percent decrease in the risk of death with carvedilol (95 percent confidence interval, 19 to 48 percent; P=0.0014, adjusted for interim analyses). A total of 507 patients died or were hospitalized in the placebo group, as compared with 425 in the carvedilol group. This difference reflected a 24 percent decrease in the combined risk of death or hospitalization with carvedilol. The favorable effects on both end points were seen consistently in all the subgroups we examined. Fewer patients in the carvedilol group than in the placebo group withdrew because of adverse effects or for other reasons (P=0.02). Conclusions The previously reported benefits of carvedilol with regard to morbidity and mortality in patients with mild-to-moderate heart failure were also found in the patients with severe heart failure who were evaluated in this trial.


Affiliations:


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Le document en format XML

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<settlement type="city">Berne</settlement>
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<name sortKey="Tendera, Michal" sort="Tendera, Michal" uniqKey="Tendera M" first="Michal" last="Tendera">Michal Tendera</name>
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<name sortKey="Castaigne, Alain" sort="Castaigne, Alain" uniqKey="Castaigne A" first="Alain" last="Castaigne">Alain Castaigne</name>
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<name sortKey="Roecker, Ellen B" sort="Roecker, Ellen B" uniqKey="Roecker E" first="Ellen B." last="Roecker">Ellen B. Roecker</name>
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<sZ>12 aut.</sZ>
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<country>États-Unis</country>
<wicri:noRegion>University of Wisconsin</wicri:noRegion>
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<name sortKey="Demets, David L" sort="Demets, David L" uniqKey="Demets D" first="David L." last="Demets">David L. Demets</name>
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<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
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<wicri:noRegion>University of Wisconsin</wicri:noRegion>
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<keywords scheme="KwdEn" xml:lang="en">
<term>Carvedilol</term>
<term>Chronic</term>
<term>Clinical trial</term>
<term>Double blind study</term>
<term>Heart failure</term>
<term>Human</term>
<term>Oral administration</term>
<term>Placebo</term>
<term>Severe</term>
<term>Survival</term>
<term>Treatment efficiency</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Insuffisance cardiaque</term>
<term>Grave</term>
<term>Chronique</term>
<term>Carvédilol</term>
<term>Essai clinique</term>
<term>Voie orale</term>
<term>Etude double insu</term>
<term>Placebo</term>
<term>Efficacité traitement</term>
<term>Survie</term>
<term>Homme</term>
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<term>Homme</term>
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<div type="abstract" xml:lang="en">Background Beta-blocking agents reduce the risk of hospitalization and death in patients with mild-to-moderate heart failure, but little is known about their effects in severe heart failure. Methods We evaluated 2289 patients who had symptoms of heart failure at rest or on minimal exertion, who were clinically euvolemic, and who had an ejection fraction of less than 25 percent. In a double-blind fashion, we randomly assigned 1133 patients to placebo and 1156 patients to treatment with carvedilol for a mean period of 10.4 months, during which standard therapy for heart failure was continued. Patients who required intensive care, had marked fluid retention, or were receiving intravenous vasodilators or positive inotropic drugs were excluded. Results There were 190 deaths in the placebo group and 130 deaths in the carvedilol group. This difference reflected a 35 percent decrease in the risk of death with carvedilol (95 percent confidence interval, 19 to 48 percent; P=0.0014, adjusted for interim analyses). A total of 507 patients died or were hospitalized in the placebo group, as compared with 425 in the carvedilol group. This difference reflected a 24 percent decrease in the combined risk of death or hospitalization with carvedilol. The favorable effects on both end points were seen consistently in all the subgroups we examined. Fewer patients in the carvedilol group than in the placebo group withdrew because of adverse effects or for other reasons (P=0.02). Conclusions The previously reported benefits of carvedilol with regard to morbidity and mortality in patients with mild-to-moderate heart failure were also found in the patients with severe heart failure who were evaluated in this trial.</div>
</front>
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<li>Allemagne</li>
<li>Australie</li>
<li>France</li>
<li>Pologne</li>
<li>Royaume-Uni</li>
<li>Suisse</li>
<li>États-Unis</li>
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<region name="Île-de-France">
<name sortKey="Castaigne, Alain" sort="Castaigne, Alain" uniqKey="Castaigne A" first="Alain" last="Castaigne">Alain Castaigne</name>
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</record>

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