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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 : 00A246 ( Main/Exploration ); précédent : 00A245; suivant : 00A247

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

Descripteurs français

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


Affiliations:


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Le document en format XML

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<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>
<keywords scheme="Wicri" type="topic" xml:lang="fr">
<term>Mortalité</term>
<term>Personne âgée</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>
<affiliations>
<list>
<country>
<li>Allemagne</li>
<li>Australie</li>
<li>Canada</li>
<li>Espagne</li>
<li>France</li>
<li>Hongrie</li>
<li>Italie</li>
<li>Pays-Bas</li>
<li>Roumanie</li>
<li>Royaume-Uni</li>
<li>République tchèque</li>
<li>Ukraine</li>
</country>
<region>
<li>Angleterre</li>
<li>Berlin</li>
<li>Catalogne</li>
<li>Grand Londres</li>
<li>Groningue (province)</li>
<li>Hongrie centrale</li>
<li>Moravie</li>
<li>Nouvelle-Galles du Sud</li>
<li>Île-de-France</li>
</region>
<settlement>
<li>Barcelone</li>
<li>Berlin</li>
<li>Brno</li>
<li>Budapest</li>
<li>Groningue</li>
<li>Londres</li>
<li>Paris</li>
<li>Sydney</li>
</settlement>
<orgName>
<li>Université de Sydney</li>
</orgName>
</list>
<tree>
<country name="Royaume-Uni">
<region name="Angleterre">
<name sortKey="Flather, Marcus D" sort="Flather, Marcus D" uniqKey="Flather M" first="Marcus D." last="Flather">Marcus D. Flather</name>
</region>
<name sortKey="Flather, Marcus D" sort="Flather, Marcus D" uniqKey="Flather M" first="Marcus D." last="Flather">Marcus D. Flather</name>
<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>
<name sortKey="Shibata, Marcelo C" sort="Shibata, Marcelo C" uniqKey="Shibata M" first="Marcelo C." last="Shibata">Marcelo C. Shibata</name>
<name sortKey="Thompson, Simon G" sort="Thompson, Simon G" uniqKey="Thompson S" first="Simon G." last="Thompson">Simon G. Thompson</name>
</country>
<country name="Canada">
<noRegion>
<name sortKey="Shibata, Marcelo C" sort="Shibata, Marcelo C" uniqKey="Shibata M" first="Marcelo C." last="Shibata">Marcelo C. Shibata</name>
</noRegion>
</country>
<country name="Australie">
<region name="Nouvelle-Galles du Sud">
<name sortKey="Coats, Andrew J S" sort="Coats, Andrew J S" uniqKey="Coats A" first="Andrew J. S." last="Coats">Andrew J. S. Coats</name>
</region>
</country>
<country name="Pays-Bas">
<region name="Groningue (province)">
<name sortKey="Van Veldhuisen, Dirk J" sort="Van Veldhuisen, Dirk J" uniqKey="Van Veldhuisen D" first="Dirk J." last="Van Veldhuisen">Dirk J. Van Veldhuisen</name>
</region>
</country>
<country name="Ukraine">
<noRegion>
<name sortKey="Parkhomenko, Aleksandr" sort="Parkhomenko, Aleksandr" uniqKey="Parkhomenko A" first="Aleksandr" last="Parkhomenko">Aleksandr Parkhomenko</name>
</noRegion>
</country>
<country name="Hongrie">
<region name="Hongrie centrale">
<name sortKey="Borbola, Joszef" sort="Borbola, Joszef" uniqKey="Borbola J" first="Joszef" last="Borbola">Joszef Borbola</name>
</region>
</country>
<country name="France">
<noRegion>
<name sortKey="Cohen Solal, Alain" sort="Cohen Solal, Alain" uniqKey="Cohen Solal A" first="Alain" last="Cohen-Solal">Alain Cohen-Solal</name>
</noRegion>
<name sortKey="Lechat, Philippe" sort="Lechat, Philippe" uniqKey="Lechat P" first="Philippe" last="Lechat">Philippe Lechat</name>
</country>
<country name="Roumanie">
<noRegion>
<name sortKey="Dumitrascu, Dan" sort="Dumitrascu, Dan" uniqKey="Dumitrascu D" first="Dan" last="Dumitrascu">Dan Dumitrascu</name>
</noRegion>
</country>
<country name="Italie">
<noRegion>
<name sortKey="Ferrari, Roberto" sort="Ferrari, Roberto" uniqKey="Ferrari R" first="Roberto" last="Ferrari">Roberto Ferrari</name>
</noRegion>
<name sortKey="Ferrari, Roberto" sort="Ferrari, Roberto" uniqKey="Ferrari R" first="Roberto" last="Ferrari">Roberto Ferrari</name>
<name sortKey="Tavazzi, Luigi" sort="Tavazzi, Luigi" uniqKey="Tavazzi L" first="Luigi" last="Tavazzi">Luigi Tavazzi</name>
</country>
<country name="Espagne">
<region name="Catalogne">
<name sortKey="Soler Soler, Jordi" sort="Soler Soler, Jordi" uniqKey="Soler Soler J" first="Jordi" last="Soler-Soler">Jordi Soler-Soler</name>
</region>
</country>
<country name="République tchèque">
<region name="Moravie">
<name sortKey="Spinarova, Lenka" sort="Spinarova, Lenka" uniqKey="Spinarova L" first="Lenka" last="Spinarova">Lenka Spinarova</name>
</region>
<name sortKey="Toman, Jiri" sort="Toman, Jiri" uniqKey="Toman J" first="Jiri" last="Toman">Jiri Toman</name>
</country>
<country name="Allemagne">
<noRegion>
<name sortKey="Bo Hm, Michael" sort="Bo Hm, Michael" uniqKey="Bo Hm M" first="Michael" last="Bo Hm">Michael Bo Hm</name>
</noRegion>
<name sortKey="Anker, Stefan D" sort="Anker, Stefan D" uniqKey="Anker S" first="Stefan D." last="Anker">Stefan D. Anker</name>
</country>
</tree>
</affiliations>
</record>

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