Effect on survival and hospitalization of initiating treatment for chronic heart failure with bisoprolol followed by enalapril, as compared with the opposite sequence : Results of the randomized cardiac insufficiency bisoprolol study (CIBIS) III
Identifieur interne : 00A665 ( Main/Exploration ); précédent : 00A664; suivant : 00A666Effect on survival and hospitalization of initiating treatment for chronic heart failure with bisoprolol followed by enalapril, as compared with the opposite sequence : Results of the randomized cardiac insufficiency bisoprolol study (CIBIS) III
Auteurs : Ronnie Willenheimer [Suède] ; Dirk J. Van Veldhuisen [Pays-Bas] ; Bernard Silke [Irlande (pays)] ; Erland Erdmann [Allemagne] ; Ferenc Follath [Suisse] ; Henry Krum [Australie] ; Piotr Ponikowski [Pologne] ; Allan Skene [Royaume-Uni] ; Louis Van De Ven [Allemagne] ; Patricia Verkenne [Allemagne] ; Philippe Lechat [France]Source :
- Circulation : (New York, N.Y.) [ 0009-7322 ] ; 2005.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Hospitalisation.
English descriptors
- KwdEn :
Abstract
Background-In patients with chronic heart failure (CHF), a /3-blocker is generally added to a regimen containing an angiotensin-converting-enzyme (ACE) inhibitor. It is unknown whether β-blockade as initial therapy may be as useful. Methods and Results-We randomized 1010 patients with mild to moderate CHF and left ventricular ejection fraction ≤35%, who were not receiving ACE inhibitor, /3-blocker, or angiotensin receptor blocker therapy, to open-label monotherapy with either bisoprolol (target dose 10 mg QD; n=505) or enalapril (target dose 10 mg BID; n=505) for 6 months, followed by their combination for 6 to 24 months. The 2 strategies were blindly compared with regard to the combined primary end point of all-cause mortality or hospitalization and with regard to each of these end point components individually. Bisoprolol-first treatment was noninferior to enalapril-first treatment if the upper limit of the 95% confidence interval (CI) for the absolute between-group difference was <5%, corresponding to a hazard ratio (HR) of 1.17. In the intention-to-treat sample, the primary end point occurred in 178 patients allocated to bisoprolol-first treatment versus 186 allocated to enalapril-first treatment (absolute difference -1.6%, 95% CI -7.6 to 4.4%, HR 0.94; 95% CI 0.77 to 1.16). In the per-protocol sample, 163 patients allocated to bisoprolol-first treatment had a primary end point, versus 165 allocated to enalapril-first treatment (absolute difference -0.7%, 95% CI -6.6 to 5.1%, HR 0.97; 95% CI 0.78 to 1.21). With bisoprolol-first treatment, 65 patients died, versus 73 with enalapril-first treatment (HR 0.88; 95% CI 0.63 to 1.22), and 151 versus 157 patients were hospitalized (HR 0.95; 95% CI 0.76 to 1.19). Conclusion-Although noninferiority of bisoprolol-first versus enalapril-first treatment was not proven in the per-protocol analysis, our results indicate that it may be as safe and efficacious to initiate treatment for CHF with bisoprolol as with enalapril.
Affiliations:
- Allemagne, Australie, France, Irlande (pays), Pays-Bas, Pologne, Royaume-Uni, Suisse, Suède
- District de Darmstadt, Hesse (Land), Victoria (État), Île-de-France
- Darmstadt, Melbourne, Paris
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Alfred Hospital</s1><s2>Melbourne</s2><s3>AUS</s3><sZ>6 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Ponikowski, Piotr" sort="Ponikowski, Piotr" uniqKey="Ponikowski P" first="Piotr" last="Ponikowski">Piotr Ponikowski</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Cardiology Department, Clinical Military Hospital</s1><s2>Wroclaw</s2><s3>POL</s3><sZ>7 aut.</sZ></inist:fA14><country>Pologne</country><wicri:noRegion>Wroclaw</wicri:noRegion></affiliation></author><author><name sortKey="Skene, Allan" sort="Skene, Allan" uniqKey="Skene A" first="Allan" last="Skene">Allan Skene</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>The Nottingham Clinical Research Limited</s1><s2>Nottingham</s2><s3>GBR</s3><sZ>8 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>The Nottingham Clinical Research Limited</wicri:noRegion></affiliation></author><author><name sortKey="Van De Ven, Louis" sort="Van De Ven, Louis" uniqKey="Van De Ven L" first="Louis" last="Van De Ven">Louis Van De Ven</name><affiliation wicri:level="3"><inist:fA14 i1="09"><s1>Merck KGaA</s1><s2>Darmstadt</s2><s3>DEU</s3><sZ>9 aut.</sZ><sZ>10 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Darmstadt</region><settlement type="city">Darmstadt</settlement></placeName></affiliation></author><author><name sortKey="Verkenne, Patricia" sort="Verkenne, Patricia" uniqKey="Verkenne P" first="Patricia" last="Verkenne">Patricia Verkenne</name><affiliation wicri:level="3"><inist:fA14 i1="09"><s1>Merck KGaA</s1><s2>Darmstadt</s2><s3>DEU</s3><sZ>9 aut.</sZ><sZ>10 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Darmstadt</region><settlement type="city">Darmstadt</settlement></placeName></affiliation></author><author><name sortKey="Lechat, Philippe" sort="Lechat, Philippe" uniqKey="Lechat P" first="Philippe" last="Lechat">Philippe Lechat</name><affiliation wicri:level="3"><inist:fA14 i1="10"><s1>Service de Pharmacologie, Hopital Pitid-Salpetriere</s1><s2>Paris</s2><s3>FRA</s3><sZ>11 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">06-0004859</idno><date when="2005">2005</date><idno type="stanalyst">PASCAL 06-0004859 INIST</idno><idno type="RBID">Pascal:06-0004859</idno><idno type="wicri:Area/PascalFrancis/Corpus">004651</idno><idno type="wicri:Area/PascalFrancis/Curation">001A44</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">004642</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">004642</idno><idno type="wicri:doubleKey">0009-7322:2005:Willenheimer R:effect:on:survival</idno><idno type="wicri:Area/Main/Merge">00B292</idno><idno type="wicri:Area/Main/Curation">00A665</idno><idno type="wicri:Area/Main/Exploration">00A665</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Effect on survival and hospitalization of initiating treatment for chronic heart failure with bisoprolol followed by enalapril, as compared with the opposite sequence : Results of the randomized cardiac insufficiency bisoprolol study (CIBIS) III</title><author><name sortKey="Willenheimer, Ronnie" sort="Willenheimer, Ronnie" uniqKey="Willenheimer R" first="Ronnie" last="Willenheimer">Ronnie Willenheimer</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Lund University, Department of Cardiology, University Hospital</s1><s2>Malmö</s2><s3>SWE</s3><sZ>1 aut.</sZ></inist:fA14><country>Suède</country><wicri:noRegion>Malmö</wicri:noRegion></affiliation></author><author><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><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Thoraxcenter, Department of Cardiology, University Hospital Groningen</s1><s3>NLD</s3><sZ>2 aut.</sZ></inist:fA14><country>Pays-Bas</country><wicri:noRegion>Thoraxcenter, Department of Cardiology, University Hospital Groningen</wicri:noRegion></affiliation></author><author><name sortKey="Silke, Bernard" sort="Silke, Bernard" uniqKey="Silke B" first="Bernard" last="Silke">Bernard Silke</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Department of Pharmacology and Therapeutics, Trinity Centre, St James' Hospital</s1><s2>Dublin</s2><s3>IRL</s3><sZ>3 aut.</sZ></inist:fA14><country>Irlande (pays)</country><wicri:noRegion>Dublin</wicri:noRegion></affiliation></author><author><name sortKey="Erdmann, Erland" sort="Erdmann, Erland" uniqKey="Erdmann E" first="Erland" last="Erdmann">Erland Erdmann</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Medizinische Klinik III, University of Cologne</s1><s3>DEU</s3><sZ>4 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>University of Cologne</wicri:noRegion><wicri:noRegion>Medizinische Klinik III, University of Cologne</wicri:noRegion></affiliation></author><author><name sortKey="Follath, Ferenc" sort="Follath, Ferenc" uniqKey="Follath F" first="Ferenc" last="Follath">Ferenc Follath</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Medicine A, University Hospital Zürich</s1><s3>CHE</s3><sZ>5 aut.</sZ></inist:fA14><country>Suisse</country><wicri:noRegion>Medicine A, University Hospital Zürich</wicri:noRegion></affiliation></author><author><name sortKey="Krum, Henry" sort="Krum, Henry" uniqKey="Krum H" first="Henry" last="Krum">Henry Krum</name><affiliation wicri:level="3"><inist:fA14 i1="06"><s1>Departments of Epidemiology and Preventive Medicine and Medicine, Monash University. Alfred Hospital</s1><s2>Melbourne</s2><s3>AUS</s3><sZ>6 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Ponikowski, Piotr" sort="Ponikowski, Piotr" uniqKey="Ponikowski P" first="Piotr" last="Ponikowski">Piotr Ponikowski</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Cardiology Department, Clinical Military Hospital</s1><s2>Wroclaw</s2><s3>POL</s3><sZ>7 aut.</sZ></inist:fA14><country>Pologne</country><wicri:noRegion>Wroclaw</wicri:noRegion></affiliation></author><author><name sortKey="Skene, Allan" sort="Skene, Allan" uniqKey="Skene A" first="Allan" last="Skene">Allan Skene</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>The Nottingham Clinical Research Limited</s1><s2>Nottingham</s2><s3>GBR</s3><sZ>8 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>The Nottingham Clinical Research Limited</wicri:noRegion></affiliation></author><author><name sortKey="Van De Ven, Louis" sort="Van De Ven, Louis" uniqKey="Van De Ven L" first="Louis" last="Van De Ven">Louis Van De Ven</name><affiliation wicri:level="3"><inist:fA14 i1="09"><s1>Merck KGaA</s1><s2>Darmstadt</s2><s3>DEU</s3><sZ>9 aut.</sZ><sZ>10 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Darmstadt</region><settlement type="city">Darmstadt</settlement></placeName></affiliation></author><author><name sortKey="Verkenne, Patricia" sort="Verkenne, Patricia" uniqKey="Verkenne P" first="Patricia" last="Verkenne">Patricia Verkenne</name><affiliation wicri:level="3"><inist:fA14 i1="09"><s1>Merck KGaA</s1><s2>Darmstadt</s2><s3>DEU</s3><sZ>9 aut.</sZ><sZ>10 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Darmstadt</region><settlement type="city">Darmstadt</settlement></placeName></affiliation></author><author><name sortKey="Lechat, Philippe" sort="Lechat, Philippe" uniqKey="Lechat P" first="Philippe" last="Lechat">Philippe Lechat</name><affiliation wicri:level="3"><inist:fA14 i1="10"><s1>Service de Pharmacologie, Hopital Pitid-Salpetriere</s1><s2>Paris</s2><s3>FRA</s3><sZ>11 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author></analytic><series><title level="j" type="main">Circulation : (New York, N.Y.)</title><title level="j" type="abbreviated">Circulation : (N. Y. N.Y.)</title><idno type="ISSN">0009-7322</idno><imprint><date when="2005">2005</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Circulation : (New York, N.Y.)</title><title level="j" type="abbreviated">Circulation : (N. Y. N.Y.)</title><idno type="ISSN">0009-7322</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>ACE inhibitor</term><term>Antihypertensive agent</term><term>Bisoprolol</term><term>Cardiovascular disease</term><term>Chronic</term><term>Enalapril</term><term>Heart failure</term><term>Hospitalization</term><term>Survival</term><term>Treatment</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Appareil circulatoire pathologie</term><term>Insuffisance cardiaque</term><term>Survie</term><term>Hospitalisation</term><term>Traitement</term><term>Chronique</term><term>Bisoprolol</term><term>Enalapril</term><term>Inhibiteur angiotensin converting enzyme</term><term>Antihypertenseur</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Hospitalisation</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Background-In patients with chronic heart failure (CHF), a /3-blocker is generally added to a regimen containing an angiotensin-converting-enzyme (ACE) inhibitor. It is unknown whether β-blockade as initial therapy may be as useful. Methods and Results-We randomized 1010 patients with mild to moderate CHF and left ventricular ejection fraction ≤35%, who were not receiving ACE inhibitor, /3-blocker, or angiotensin receptor blocker therapy, to open-label monotherapy with either bisoprolol (target dose 10 mg QD; n=505) or enalapril (target dose 10 mg BID; n=505) for 6 months, followed by their combination for 6 to 24 months. The 2 strategies were blindly compared with regard to the combined primary end point of all-cause mortality or hospitalization and with regard to each of these end point components individually. Bisoprolol-first treatment was noninferior to enalapril-first treatment if the upper limit of the 95% confidence interval (CI) for the absolute between-group difference was <5%, corresponding to a hazard ratio (HR) of 1.17. In the intention-to-treat sample, the primary end point occurred in 178 patients allocated to bisoprolol-first treatment versus 186 allocated to enalapril-first treatment (absolute difference -1.6%, 95% CI -7.6 to 4.4%, HR 0.94; 95% CI 0.77 to 1.16). In the per-protocol sample, 163 patients allocated to bisoprolol-first treatment had a primary end point, versus 165 allocated to enalapril-first treatment (absolute difference -0.7%, 95% CI -6.6 to 5.1%, HR 0.97; 95% CI 0.78 to 1.21). With bisoprolol-first treatment, 65 patients died, versus 73 with enalapril-first treatment (HR 0.88; 95% CI 0.63 to 1.22), and 151 versus 157 patients were hospitalized (HR 0.95; 95% CI 0.76 to 1.19). Conclusion-Although noninferiority of bisoprolol-first versus enalapril-first treatment was not proven in the per-protocol analysis, our results indicate that it may be as safe and efficacious to initiate treatment for CHF with bisoprolol as with enalapril.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>France</li><li>Irlande (pays)</li><li>Pays-Bas</li><li>Pologne</li><li>Royaume-Uni</li><li>Suisse</li><li>Suède</li></country><region><li>District de Darmstadt</li><li>Hesse (Land)</li><li>Victoria (État)</li><li>Île-de-France</li></region><settlement><li>Darmstadt</li><li>Melbourne</li><li>Paris</li></settlement></list><tree><country name="Suède"><noRegion><name sortKey="Willenheimer, Ronnie" sort="Willenheimer, Ronnie" uniqKey="Willenheimer R" first="Ronnie" last="Willenheimer">Ronnie Willenheimer</name></noRegion></country><country name="Pays-Bas"><noRegion><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></noRegion></country><country name="Irlande (pays)"><noRegion><name sortKey="Silke, Bernard" sort="Silke, Bernard" uniqKey="Silke B" first="Bernard" last="Silke">Bernard Silke</name></noRegion></country><country name="Allemagne"><noRegion><name sortKey="Erdmann, Erland" sort="Erdmann, Erland" uniqKey="Erdmann E" first="Erland" last="Erdmann">Erland Erdmann</name></noRegion><name sortKey="Van De Ven, Louis" sort="Van De Ven, Louis" uniqKey="Van De Ven L" first="Louis" last="Van De Ven">Louis Van De Ven</name><name sortKey="Verkenne, Patricia" sort="Verkenne, Patricia" uniqKey="Verkenne P" first="Patricia" last="Verkenne">Patricia Verkenne</name></country><country name="Suisse"><noRegion><name sortKey="Follath, Ferenc" sort="Follath, Ferenc" uniqKey="Follath F" first="Ferenc" last="Follath">Ferenc Follath</name></noRegion></country><country name="Australie"><region name="Victoria (État)"><name sortKey="Krum, Henry" sort="Krum, Henry" uniqKey="Krum H" first="Henry" last="Krum">Henry Krum</name></region></country><country name="Pologne"><noRegion><name sortKey="Ponikowski, Piotr" sort="Ponikowski, Piotr" uniqKey="Ponikowski P" first="Piotr" last="Ponikowski">Piotr Ponikowski</name></noRegion></country><country name="Royaume-Uni"><noRegion><name sortKey="Skene, Allan" sort="Skene, Allan" uniqKey="Skene A" first="Allan" last="Skene">Allan Skene</name></noRegion></country><country name="France"><region name="Île-de-France"><name sortKey="Lechat, Philippe" sort="Lechat, Philippe" uniqKey="Lechat P" first="Philippe" last="Lechat">Philippe Lechat</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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