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Randomized trial to determine the effect of nebivolol on mortality and cardiovascular hospital admission in elderly patients with heart failure (SENIORS)

Identifieur interne : 000687 ( Istex/Curation ); précédent : 000686; suivant : 000688

Randomized trial to determine the effect of nebivolol on mortality and cardiovascular hospital admission in elderly patients with heart failure (SENIORS)

Auteurs : Marcus D. Flather [Royaume-Uni] ; Marcelo C. Shibata [Royaume-Uni, Canada] ; Andrew J. S. Coats [Australie] ; Dirk J. Van Veldhuisen [Pays-Bas] ; Aleksandr Parkhomenko [Ukraine] ; Joszef Borbola [Hongrie] ; Alain Cohen-Solal [France] ; Dan Dumitrascu [Roumanie] ; Roberto Ferrari [Italie] ; Philippe Lechat [France] ; Jordi Soler-Soler [Espagne] ; Luigi Tavazzi [Italie] ; Lenka Spinarova [République tchèque] ; Jiri Toman [République tchèque] ; Michael Bo Hm [Allemagne] ; Stefan D. Anker [Allemagne] ; Simon G. Thompson [Royaume-Uni] ; Philip A. Poole-Wilson [Royaume-Uni]

Source :

RBID : ISTEX:233088D5382ECAD4BF8A5104C5D468729CDD526F

English descriptors

Abstract

Aims Large randomized trials have shown that beta-blockers reduce mortality and hospital admissions in patients with heart failure. The effects of beta-blockers in elderly patients with a broad range of left ventricular ejection fraction are uncertain. The SENIORS study was performed to assess effects of the beta-blocker, nebivolol, in patients ≥70 years, regardless of ejection fraction. Methods and results We randomly assigned 2128 patients aged ≥70 years with a history of heart failure (hospital admission for heart failure within the previous year or known ejection fraction ≤35%), 1067 to nebivolol (titrated from 1.25 mg once daily to 10 mg once daily), and 1061 to placebo. The primary outcome was a composite of all cause mortality or cardiovascular hospital admission (time to first event). Analysis was by intention to treat. Mean duration of follow-up was 21 months. Mean age was 76 years (SD 4.7), 37% were female, mean ejection fraction was 36% (with 35% having ejection fraction >35%), and 68% had a prior history of coronary heart disease. The mean maintenance dose of nebivolol was 7.7 mg and of placebo 8.5 mg. The primary outcome occurred in 332 patients (31.1%) on nebivolol compared with 375 (35.3%) on placebo [hazard ratio (HR) 0.86, 95% CI 0.74–0.99; P=0.039]. There was no significant influence of age, gender, or ejection fraction on the effect of nebivolol on the primary outcome. Death (all causes) occurred in 169 (15.8%) on nebivolol and 192 (18.1%) on placebo (HR 0.88, 95% CI 0.71–1.08; P=0.21). Conclusion Nebivolol, a beta-blocker with vasodilating properties, is an effective and well-tolerated treatment for heart failure in the elderly.

Url:
DOI: 10.1093/eurheartj/ehi115

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ISTEX:233088D5382ECAD4BF8A5104C5D468729CDD526F

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Andrew J. S. Coats
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<mods:affiliation>Corresponding author. Tel: +61293514579; fax +61293516645. E-mail address: ajscoats@aol.com</mods:affiliation>
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<author>
<name sortKey="Thompson, Simon G" sort="Thompson, Simon G" uniqKey="Thompson S" first="Simon G." last="Thompson">Simon G. Thompson</name>
<affiliation wicri:level="1">
<mods:affiliation>Medical Research Council Biostatistics Unit, Cambridge, UK</mods:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Medical Research Council Biostatistics Unit, Cambridge</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Poole Wilson, Philip A" sort="Poole Wilson, Philip A" uniqKey="Poole Wilson P" first="Philip A." last="Poole-Wilson">Philip A. Poole-Wilson</name>
<affiliation wicri:level="1">
<mods:affiliation>National Heart and Lung Institute, Imperial College of Science Technology and Medicine, London, UK</mods:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>National Heart and Lung Institute, Imperial College of Science Technology and Medicine, London</wicri:regionArea>
</affiliation>
</author>
</analytic>
<monogr></monogr>
<series>
<title level="j">European Heart Journal</title>
<title level="j" type="abbrev">Eur Heart J</title>
<idno type="ISSN">0195-668X</idno>
<idno type="eISSN">1522-9645</idno>
<imprint>
<publisher>Oxford University Press</publisher>
<date type="published" when="2005-02">2005-02</date>
<biblScope unit="volume">26</biblScope>
<biblScope unit="issue">3</biblScope>
<biblScope unit="page" from="215">215</biblScope>
<biblScope unit="page" to="225">225</biblScope>
</imprint>
<idno type="ISSN">0195-668X</idno>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt>
<idno type="ISSN">0195-668X</idno>
</seriesStmt>
</fileDesc>
<profileDesc>
<textClass>
<keywords scheme="KwdEn" xml:lang="en">
<term>Adverse events</term>
<term>Aleksandr parkhomenko</term>
<term>Annual rate</term>
<term>Baseline</term>
<term>Beta adrenergic blockade</term>
<term>Beta blockers</term>
<term>Beta-blocker</term>
<term>Blocker</term>
<term>Blood pressure</term>
<term>Broad range</term>
<term>Cardiac</term>
<term>Cardiology</term>
<term>Cardiovascular</term>
<term>Cardiovascular deaths</term>
<term>Cardiovascular hospital admission</term>
<term>Cardiovascular hospital admissions</term>
<term>Cardiovascular mortality</term>
<term>Carvedilol</term>
<term>Cause death</term>
<term>Cause hospital admissions</term>
<term>Cause hospitalization</term>
<term>Cause mortality</term>
<term>Charite campus berlin</term>
<term>Chronic heart failure</term>
<term>Clinical trials</term>
<term>Cluj napoca</term>
<term>Coll cardiol</term>
<term>Congestive heart failure</term>
<term>Czech republic</term>
<term>Data management</term>
<term>Data safety</term>
<term>Diastolic blood pressure</term>
<term>Diastolic heart failure</term>
<term>Drug intake</term>
<term>Ejection</term>
<term>Ejection fraction</term>
<term>Elderly</term>
<term>Elderly heart failure patients</term>
<term>Elderly patients</term>
<term>European heart journal</term>
<term>European society</term>
<term>Evaluation unit</term>
<term>Flather</term>
<term>Hazard ratio</term>
<term>Heart failure</term>
<term>Heart rate</term>
<term>Hopital paris</term>
<term>Hospital admission</term>
<term>Hospital admissions</term>
<term>Hungarian institute</term>
<term>Imperial college</term>
<term>Interaction test</term>
<term>Irccs policlinico</term>
<term>Jiri toman</term>
<term>Lancet</term>
<term>Large randomized trials</term>
<term>Last observation</term>
<term>Lenka spinarova</term>
<term>Luigi tavazzi</term>
<term>Maintenance dose</term>
<term>Marcelo shibata</term>
<term>Marcus flather</term>
<term>Masaryk university hospital</term>
<term>Median</term>
<term>Medical research council biostatistics unit</term>
<term>Menarini ricerche</term>
<term>Michael bohm</term>
<term>Mmhg</term>
<term>Monitoring committee</term>
<term>Morbidity studies</term>
<term>Mudr</term>
<term>Myocardial infarction</term>
<term>Nebivolol</term>
<term>Nebivolol group</term>
<term>Nebivolol intervention</term>
<term>Placebo</term>
<term>Placebo group</term>
<term>Placebo groups</term>
<term>Previous studies</term>
<term>Previous trials</term>
<term>Previous year</term>
<term>Primary endpoint</term>
<term>Primary outcome</term>
<term>Primary outcomec</term>
<term>Prof</term>
<term>Randomization</term>
<term>Randomized</term>
<term>Randomized trial</term>
<term>Randomized trials</term>
<term>Risk reduction</term>
<term>Roberto ferrari</term>
<term>Royal brompton</term>
<term>Safety concerns</term>
<term>Safety monitoring committee</term>
<term>Salvatore maugeri foundation</term>
<term>Sample size</term>
<term>Science technology</term>
<term>Secondary outcomes</term>
<term>Seniors study</term>
<term>Seniors trial</term>
<term>Steering committee</term>
<term>Study medication</term>
<term>Subgroup</term>
<term>Systolic</term>
<term>Systolic blood pressure</term>
<term>Task force</term>
<term>Titration phase</term>
<term>Unadjusted analysis</term>
<term>Vall barcelona</term>
<term>Vasodilating properties</term>
<term>Ventricular</term>
<term>Ventricular dysfunction</term>
<term>Ventricular ejection fraction</term>
<term>Ventricular function</term>
<term>Younger patients</term>
</keywords>
<keywords scheme="Teeft" xml:lang="en">
<term>Adverse events</term>
<term>Aleksandr parkhomenko</term>
<term>Annual rate</term>
<term>Baseline</term>
<term>Beta adrenergic blockade</term>
<term>Beta blockers</term>
<term>Blocker</term>
<term>Blood pressure</term>
<term>Broad range</term>
<term>Cardiac</term>
<term>Cardiology</term>
<term>Cardiovascular</term>
<term>Cardiovascular deaths</term>
<term>Cardiovascular hospital admission</term>
<term>Cardiovascular hospital admissions</term>
<term>Cardiovascular mortality</term>
<term>Carvedilol</term>
<term>Cause death</term>
<term>Cause hospital admissions</term>
<term>Cause hospitalization</term>
<term>Cause mortality</term>
<term>Charite campus berlin</term>
<term>Chronic heart failure</term>
<term>Clinical trials</term>
<term>Cluj napoca</term>
<term>Coll cardiol</term>
<term>Congestive heart failure</term>
<term>Czech republic</term>
<term>Data management</term>
<term>Data safety</term>
<term>Diastolic blood pressure</term>
<term>Diastolic heart failure</term>
<term>Drug intake</term>
<term>Ejection</term>
<term>Ejection fraction</term>
<term>Elderly heart failure patients</term>
<term>Elderly patients</term>
<term>European heart journal</term>
<term>European society</term>
<term>Evaluation unit</term>
<term>Flather</term>
<term>Hazard ratio</term>
<term>Heart failure</term>
<term>Heart rate</term>
<term>Hopital paris</term>
<term>Hospital admission</term>
<term>Hospital admissions</term>
<term>Hungarian institute</term>
<term>Imperial college</term>
<term>Interaction test</term>
<term>Irccs policlinico</term>
<term>Jiri toman</term>
<term>Lancet</term>
<term>Large randomized trials</term>
<term>Last observation</term>
<term>Lenka spinarova</term>
<term>Luigi tavazzi</term>
<term>Maintenance dose</term>
<term>Marcelo shibata</term>
<term>Marcus flather</term>
<term>Masaryk university hospital</term>
<term>Median</term>
<term>Medical research council biostatistics unit</term>
<term>Menarini ricerche</term>
<term>Michael bohm</term>
<term>Mmhg</term>
<term>Monitoring committee</term>
<term>Morbidity studies</term>
<term>Mudr</term>
<term>Myocardial infarction</term>
<term>Nebivolol</term>
<term>Nebivolol group</term>
<term>Nebivolol intervention</term>
<term>Placebo</term>
<term>Placebo group</term>
<term>Placebo groups</term>
<term>Previous studies</term>
<term>Previous trials</term>
<term>Previous year</term>
<term>Primary endpoint</term>
<term>Primary outcome</term>
<term>Primary outcomec</term>
<term>Prof</term>
<term>Randomization</term>
<term>Randomized</term>
<term>Randomized trials</term>
<term>Risk reduction</term>
<term>Roberto ferrari</term>
<term>Royal brompton</term>
<term>Safety concerns</term>
<term>Safety monitoring committee</term>
<term>Salvatore maugeri foundation</term>
<term>Sample size</term>
<term>Science technology</term>
<term>Secondary outcomes</term>
<term>Seniors study</term>
<term>Seniors trial</term>
<term>Steering committee</term>
<term>Study medication</term>
<term>Subgroup</term>
<term>Systolic</term>
<term>Systolic blood pressure</term>
<term>Task force</term>
<term>Titration phase</term>
<term>Unadjusted analysis</term>
<term>Vall barcelona</term>
<term>Vasodilating properties</term>
<term>Ventricular</term>
<term>Ventricular dysfunction</term>
<term>Ventricular ejection fraction</term>
<term>Ventricular function</term>
<term>Younger patients</term>
</keywords>
</textClass>
<langUsage>
<language ident="en">en</language>
</langUsage>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">Aims Large randomized trials have shown that beta-blockers reduce mortality and hospital admissions in patients with heart failure. The effects of beta-blockers in elderly patients with a broad range of left ventricular ejection fraction are uncertain. The SENIORS study was performed to assess effects of the beta-blocker, nebivolol, in patients ≥70 years, regardless of ejection fraction. Methods and results We randomly assigned 2128 patients aged ≥70 years with a history of heart failure (hospital admission for heart failure within the previous year or known ejection fraction ≤35%), 1067 to nebivolol (titrated from 1.25 mg once daily to 10 mg once daily), and 1061 to placebo. The primary outcome was a composite of all cause mortality or cardiovascular hospital admission (time to first event). Analysis was by intention to treat. Mean duration of follow-up was 21 months. Mean age was 76 years (SD 4.7), 37% were female, mean ejection fraction was 36% (with 35% having ejection fraction >35%), and 68% had a prior history of coronary heart disease. The mean maintenance dose of nebivolol was 7.7 mg and of placebo 8.5 mg. The primary outcome occurred in 332 patients (31.1%) on nebivolol compared with 375 (35.3%) on placebo [hazard ratio (HR) 0.86, 95% CI 0.74–0.99; P=0.039]. There was no significant influence of age, gender, or ejection fraction on the effect of nebivolol on the primary outcome. Death (all causes) occurred in 169 (15.8%) on nebivolol and 192 (18.1%) on placebo (HR 0.88, 95% CI 0.71–1.08; P=0.21). Conclusion Nebivolol, a beta-blocker with vasodilating properties, is an effective and well-tolerated treatment for heart failure in the elderly.</div>
</front>
</TEI>
</record>

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