Covariate adjusted reanalysis of the I-Preserve trial.

Aged Angiotensin II Type 1 Receptor Blockers / therapeutic use Angiotensin Receptor Antagonists / therapeutic use Female Heart Failure / drug therapy Hospitalization / trends Humans Male Middle Aged Prognosis Stroke Volume / physiology
Covariate adjustment Heart failure with preserved ejection fraction Irbesartan Treatment effects

Journal

Clinical research in cardiology : official journal of the German Cardiac Society
ISSN: 1861-0692
Titre abrégé: Clin Res Cardiol
Pays: Germany
ID NLM: 101264123

Informations de publication

Date de publication:
Nov 2020
Historique:
received: 18 01 2020
accepted: 11 03 2020
pubmed: 28 3 2020
medline: 11 8 2021
entrez: 28 3 2020
Statut: ppublish

Résumé

The CHARM-Preserved trial suggested that the renin-angiotensin system (RAS) inhibitor candesartan might have been beneficial in heart failure with preserved ejection fraction (HFpEF); however, this hypothesis was not supported by the findings of I-Preserve with irbesartan. To re-analyse the results of I-Preserve, adjusting for imbalances in baseline variables that may have influenced the trial outcomes. Cox proportional hazards models with covariate adjustment for baseline variables, including age, sex, medical history, physiological and laboratory variables. In I-Preserve, 763 (37.0%) participants in the placebo group and 742 (35.9%) in the irbesartan group experienced the primary composite outcome (death from any cause or hospitalization for heart failure, myocardial infarction, unstable angina, arrhythmia, or stroke). The prespecified analysis of this outcome, stratifying for the use of ACEi at baseline, gave a hazard ratio (HR) of 0.95 (95% confidence interval, 0.86-1.05); p = 0.35. Adjusting the effect of treatment for key prognostic baseline variables, gave a HR of 0.89 (0.80-0.99); p = 0.033. Similar findings were observed for the composite of cardiovascular death or HF hospitalization. Adjusting for imbalances in baseline variables that influence outcomes (or the response to therapy or both) can improve the power around the estimate of the effect of treatment and may alter its statistical significance. Along with the CHARM-Preserved results, these findings suggest that angiotensin-receptor blockers may have a modest effect in HFpEF.

Sections du résumé

BACKGROUND BACKGROUND
The CHARM-Preserved trial suggested that the renin-angiotensin system (RAS) inhibitor candesartan might have been beneficial in heart failure with preserved ejection fraction (HFpEF); however, this hypothesis was not supported by the findings of I-Preserve with irbesartan.
AIMS OBJECTIVE
To re-analyse the results of I-Preserve, adjusting for imbalances in baseline variables that may have influenced the trial outcomes.
METHODS METHODS
Cox proportional hazards models with covariate adjustment for baseline variables, including age, sex, medical history, physiological and laboratory variables.
RESULTS RESULTS
In I-Preserve, 763 (37.0%) participants in the placebo group and 742 (35.9%) in the irbesartan group experienced the primary composite outcome (death from any cause or hospitalization for heart failure, myocardial infarction, unstable angina, arrhythmia, or stroke). The prespecified analysis of this outcome, stratifying for the use of ACEi at baseline, gave a hazard ratio (HR) of 0.95 (95% confidence interval, 0.86-1.05); p = 0.35. Adjusting the effect of treatment for key prognostic baseline variables, gave a HR of 0.89 (0.80-0.99); p = 0.033. Similar findings were observed for the composite of cardiovascular death or HF hospitalization.
CONCLUSION CONCLUSIONS
Adjusting for imbalances in baseline variables that influence outcomes (or the response to therapy or both) can improve the power around the estimate of the effect of treatment and may alter its statistical significance. Along with the CHARM-Preserved results, these findings suggest that angiotensin-receptor blockers may have a modest effect in HFpEF.

Identifiants

DOI: 10.1007/s00392-020-01632-x PMID: 32215700
pubmed: 32215700
doi: 10.1007/s00392-020-01632-x
pii: 10.1007/s00392-020-01632-x
doi:

Substances chimiques

Angiotensin II Type 1 Receptor Blockers 0
Angiotensin Receptor Antagonists 0

Types de publication

Clinical Trial Comparative Study Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

1358-1365

Auteurs

João Pedro Ferreira (JP)

BHF Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow, G12 8TA, UK.
National Institute of Health and Medical Research (INSERM), Center for Clinical Multidisciplinary Research 1433, INSERM U1116, French Clinical Research Infrastructure Network (F-CRIN) Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists (INI-CRCT), University of Lorraine, Regional University Hospital of Nancy, Nancy, France.

Pooja Dewan (P)

BHF Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow, G12 8TA, UK.

Pardeep S Jhund (PS)

BHF Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow, G12 8TA, UK.

Ana Lorenzo-Almorós (A)

Department of Internal Medicine. Renal, Vascular and Diabetes Laboratory, Instituto de Investigaciones Sanitarias Fundación Jiménez Díaz, Universidad Autónoma de Madrid, Madrid, Spain.

Kévin Duarte (K)

National Institute of Health and Medical Research (INSERM), Center for Clinical Multidisciplinary Research 1433, INSERM U1116, French Clinical Research Infrastructure Network (F-CRIN) Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists (INI-CRCT), University of Lorraine, Regional University Hospital of Nancy, Nancy, France.

Mark C Petrie (MC)

BHF Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow, G12 8TA, UK.

Peter E Carson (PE)

Cardiovascular Division, Department of Cardiology, Washington Veterans Affairs Medical Center, Washington, DC, USA.

Robert McKelvie (R)

Department of Medicine, Western University, London, ON, Canada.

Michel Komajda (M)

Service de Cardiologie, Hôpital Saint Joseph, Paris, France.

Michael Zile (M)

Medical University of South Carolina and Ralph H. Johnson Veterans Administration Medical Center, Charleston, South Carolina, USA.

Faiez Zannad (F)

National Institute of Health and Medical Research (INSERM), Center for Clinical Multidisciplinary Research 1433, INSERM U1116, French Clinical Research Infrastructure Network (F-CRIN) Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists (INI-CRCT), University of Lorraine, Regional University Hospital of Nancy, Nancy, France.

John J V McMurray (JJV)

BHF Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow, G12 8TA, UK. john.mcmurray@glasgow.ac.uk.

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Classifications MeSH

questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Sujet âgé › Covariate adjusted reanalysis of the I-Preserve trial.
questionsmedicales.fr › Actions chimiques et utilisations › Actions pharmacologiques › Mécanismes moléculaires de l'action pharmacologique › Antagonistes des récepteurs aux angiotensines › Antagonistes du récepteur de type 1 de l'angiotensine-II › Covariate adjusted reanalysis of the I-Preserve trial.
questionsmedicales.fr › Actions chimiques et utilisations › Actions pharmacologiques › Mécanismes moléculaires de l'action pharmacologique › Antagonistes des récepteurs aux angiotensines › Covariate adjusted reanalysis of the I-Preserve trial.
questionsmedicales.fr › Maladies cardiovasculaires › Cardiopathies › Défaillance cardiaque › Covariate adjusted reanalysis of the I-Preserve trial.
questionsmedicales.fr › Établissements, main d'oeuvre et services de soins de santé › Services de santé › Soins aux patients › Hospitalisation › Covariate adjusted reanalysis of the I-Preserve trial.
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Covariate adjusted reanalysis of the I-Preserve trial.
questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Adulte d'âge moyen › Covariate adjusted reanalysis of the I-Preserve trial.
questionsmedicales.fr › Diagnostic › Pronostic › Covariate adjusted reanalysis of the I-Preserve trial.
questionsmedicales.fr › Phénomènes physiologiques respiratoires et circulatoires › Phénomènes physiologiques cardiovasculaires › Hémodynamique › Débit cardiaque › Débit systolique › Covariate adjusted reanalysis of the I-Preserve trial.