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Plain Language Summary of PublicationOpen Accesscc iconby iconnc iconnd icon

Drug treatment with empagliflozin was beneficial in people with heart failure with preserved ejection fraction: plain language summary of the EMPEROR-Preserved study

    Faiez Zannad

    Université de Lorraine, Inserm INI-CRCT, CHRU, Nancy, France

    &
    Steven Macari

    Patient author

    The Heart Failure Policy Network

    Global Heart Hub, Galway, Ireland

    INI-CRCT Expert Patient Committee Member

    President of AVEC Heart Failure Patient Group

    Published Online:https://doi.org/10.2217/fca-2023-0091

    Abstract

    What is this summary about?

    This summary describes a study of a new pill for treating chronic heart failure called empagliflozin (brand name Jardiance®). The study is called EMPEROR-Preserved and was published in the New England Journal of Medicine. Chronic heart failure is a condition where the heart does not pump blood around the body properly. Heart failure causes symptoms such as shortness of breath, tiredness and build-up of too much water in the body (fluid retention). These symptoms often need hospital treatment and increase the risk of early death.

    What was the EMPEROR-Preserved study?

    The EMPEROR-Preserved study looked at how empagliflozin works in people living with a type of heart failure called heart failure with preserved ejection fraction. In this type of heart failure, the lower left chamber (ventricle) of the heart is too stiff to fill with enough blood during each heartbeat.

    What happened during the study?

    Almost 6000 people living with preserved ejection fraction heart failure were asked to take either a pill containing empagliflozin or a placebo, an identical pill lacking empagliflozin, daily. The choice of pill for each participant was randomly assigned. The study was double-blinded, meaning that neither the participants nor their doctors knew which pill the participants were taking.

    What were the results?

    After an average of 26 months of treatment, empagliflozin reduced the risk of participants needing hospital treatment for complications of heart failure by about 30%. Side effects were generally similar in participants who took empagliflozin and in those who took the placebo, except for genital infections like thrush, which happened in more people who took empagliflozin (2.2%) than in those who took the placebo (0.7%).

    What do the results mean?

    A previous study called EMPEROR-Reduced found that empagliflozin had similar benefits in participants with heart failure with reduced ejection fraction. Therefore, the overall evidence shows that empagliflozin can help people with heart failure whether it is caused by reduced ejection fraction or preserved ejection fraction.

    Clinical Trial Registration: NCT03057951 (EMPEROR-Preserved study) (ClinicalTrials.gov)

    Tweetable abstract

    This plain language summary describes the effect of empagliflozin in people with heart failure with preserved ejection fraction in the EMPEROR-Preserved study, which was published in the New England Journal of Medicine

    This is an abstract of the Plain Language Summary of Publication article.

    To read the full Plain Language Summary of this article, click here to view the PDF.

    Link to original article here

    Acknowledgments

    The authors and study sponsors thank all the people who participated in the study.

    Financial disclosure

    Faiez Zannad received personal consulting fees or fees for participating in running clinical trials from Boehringer Ingelheim during the conduct of the EMPEROR-Preserved study, from Applied Therapeutics, AstraZeneca, Bayer, Cardior, Cellprothera, Cereno Pharmaceutical, CVRx, Janssen, Merck, Novartis and Vifor Fresenius outside the submitted work, and other support from Cardiorenal and CVCT outside the submitted work. Steven Macari has worked on projects with AstraZeneca, Bayer, Boehringer Ingelheim, CLS Vifor, CVCT, Global Heart Hub, INSERM CIC-P CHRU de Nancy – INI CRCT, Kidney Disease Clinical Trialists, Optim'IC, Pfizer, Novartis, Servier and The Heart Failure Policy Network. Steven Macari did not receive any financial remuneration for this Plain Language Summary of Publication. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

    Competing interests disclosure

    Faiez Zannad was one of the authors of the original article in the New England Journal of Medicine (N. Engl. J. Med. 385, 1451–1461 [2021]). The authors have no other competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript apart from those disclosed.

    Writing disclosure

    Writing assistance for this plain language summary was provided by Giles Brooke, PhD, of Elevate Scientific Solutions, and was supported financially by Boehringer Ingelheim.

    Open access

    This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/4.0/