Effects of low-dose oral enoximone administration on mortality, morbidity, and exercise capacity in patients with advanced heart failure: the randomized, double-blind, placebo-controlled, parallel group ESSENTIAL trials

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dc.contributor.authorMetra, Marco
dc.contributor.authorEichhorn, Eric
dc.contributor.authorAbraham, William T.
dc.contributor.authorLinseman, Jennifer
dc.contributor.authorBoehm, Michael
dc.contributor.authorCorbalan, Ramon
dc.contributor.authorDeMets, David
dc.contributor.authorDe Marco, Teresa
dc.contributor.authorElkayam, Uri
dc.contributor.authorGerber, Michael
dc.contributor.authorKomajda, Michel
dc.contributor.authorLiu, Peter
dc.contributor.authorMareev, Vyacheslev
dc.contributor.authorPerrone, Sergio V.
dc.contributor.authorPoole Wilson, Philip
dc.contributor.authorRoecker, Ellen
dc.contributor.authorStewart, Jennifer
dc.contributor.authorSwedberg, Karl
dc.contributor.authorTendera, Michal
dc.contributor.authorWiens, Brian
dc.contributor.authorBristow, Michael R.
dc.contributor.authorESSENTIAL Investigators
dc.date.accessioned2024-01-10T13:12:37Z
dc.date.available2024-01-10T13:12:37Z
dc.date.issued2009
dc.description.abstractUse of inotropic agents in patients with heart failure (HF) has been limited by adverse effects on outcomes. However, administration of positive inotropes at lower doses and concomitant treatment with beta-blockers might increase benefit-risk ratio. We investigated the effects of low doses of the positive inotrope enoximone on symptoms, exercise capacity, and major clinical outcomes in patients with advanced HF who were also treated with beta-blockers and other guideline-recommended background therapy.
dc.description.abstractThe Studies of Oral Enoximone Therapy in Advanced HF (ESSENTIAL) programme consisted of two identical, randomized, double-blind, placebo-controlled trials that differed only by geographic location (North and South America: ESSENTIAL-I; Europe: ESSENTIAL-II). Patients with New York Heart Association class III-IV HF symptoms, left ventricular ejection fraction < 30%, and one hospitalization or two ambulatory visits for worsening HF in the previous year were eligible for participation in the trials. The trials had three co-primary endpoints: (i) the composite of time to all-cause mortality or cardiovascular hospitalization, analysed in the two ESSENTIAL trials combined; (ii) the 6 month change from baseline in the 6 min walk test distance (6MWTD); and (iii) the Patient Global Assessment (PGA) at 6 months, both analysed in each trial separately. ESSENTIAL-I and -II randomized 1854 subjects at 211 sites in 16 countries. In the combined trials, all-cause mortality and the composite, first co-primary endpoint did not differ between the two treatment groups [hazard ratio (HR) 0.97; 95% confidence interval (CI) 0.80-1.17; and HR 0.98; 95% CI 0.86-1.12, respectively, for enoximone vs. placebo]. The two other co-primary endpoints were analysed separately in the two ESSENTIAL trials, as prospectively designed in the protocol. The 6MWTD increased with enoximone, compared with placebo, in ESSENTIAL-I (P = 0.025, not reaching, however, the pre-specified criterion for statistical significance of P < 0.020), but not in ESSENTIAL-II. No difference in PGA was observed in either trial.
dc.description.abstractAlthough low-dose enoximone appears to be safe in patients with advanced HF, major clinical outcomes are not improved.
dc.description.funderMyogen, Inc.
dc.description.funderDenver, CO, USA
dc.fechaingreso.objetodigital2024-04-30
dc.format.extent12 páginas
dc.fuente.origenWOS
dc.identifier.doi10.1093/eurheartj/ehp338
dc.identifier.issn0195-668X
dc.identifier.pubmedidMEDLINE:19700774
dc.identifier.urihttps://doi.org/10.1093/eurheartj/ehp338
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/78209
dc.identifier.wosidWOS:000272927300017
dc.information.autorucMedicina;Castro, P.;S/I;100212
dc.information.autorucMedicina;Corbalán R;S/I;98700
dc.issue.numero24
dc.language.isoen
dc.nota.accesocontenido completo
dc.pagina.final3026
dc.pagina.inicio3015
dc.publisherOXFORD UNIV PRESS
dc.revistaEUROPEAN HEART JOURNAL
dc.rightsacceso abierto
dc.subjectAdvanced heart failure
dc.subjectInotropic agents
dc.subjectEnoximone
dc.subjectBETA-BLOCKERS
dc.subjectFOLLOW-UP
dc.subjectTHERAPY
dc.subjectSURVIVAL
dc.subjectDOBUTAMINE
dc.subjectCARVEDILOL
dc.subjectMETOPROLOL
dc.subjectENALAPRIL
dc.subjectMILRINONE
dc.subjectOUTCOMES
dc.subject.ods03 Good Health and Well-being
dc.subject.odspa03 Salud y bienestar
dc.titleEffects of low-dose oral enoximone administration on mortality, morbidity, and exercise capacity in patients with advanced heart failure: the randomized, double-blind, placebo-controlled, parallel group ESSENTIAL trials
dc.typeartículo
dc.volumen30
sipa.codpersvinculados100212
sipa.codpersvinculados98700
sipa.indexWOS
sipa.indexScopus
sipa.trazabilidadCarga SIPA;09-01-2024
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