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      Potassium binders for patients with heart failure? The real enlightenment of the DIAMOND trial  

      editorial
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      Publication date (Electronic):
      Journal: European Heart Journal
      Publisher: Oxford University Press

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          Estimation of Number-Needed-to-Treat with Patiromer for 3 years to Prevent One Cardiovascular Death or Hospitalization for Heart failure in Patients with Heart Failure and a Reduced Ejection Fraction. Estimates of number-needed-to-treat for the RALES and EMPHASIS-HF trials are derived from calculations published by Ferreira et al. 13 Estimates for the DIAMOND trial are derived from results presented by Butler et al. 11 Abbreviations: MRA = mineralocorticoid receptor antagonist. HFrEF = heart failure and a reduced ejection fraction.

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          The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators.

          B. Pitt, F Zannad, W J Remme … (1999)
          Aldosterone is important in the pathophysiology of heart failure. In a doubleblind study, we enrolled 1663 patients who had severe heart failure and a left ventricular ejection fraction of no more than 35 percent and who were being treated with an angiotensin-converting-enzyme inhibitor, a loop diuretic, and in most cases digoxin. A total of 822 patients were randomly assigned to receive 25 mg of spironolactone daily, and 841 to receive placebo. The primary end point was death from all causes. The trial was discontinued early, after a mean follow-up period of 24 months, because an interim analysis determined that spironolactone was efficacious. There were 386 deaths in the placebo group (46 percent) and 284 in the spironolactone group (35 percent; relative risk of death, 0.70; 95 percent confidence interval, 0.60 to 0.82; P<0.001). This 30 percent reduction in the risk of death among patients in the spironolactone group was attributed to a lower risk of both death from progressive heart failure and sudden death from cardiac causes. The frequency of hospitalization for worsening heart failure was 35 percent lower in the spironolactone group than in the placebo group (relative risk of hospitalization, 0.65; 95 percent confidence interval, 0.54 to 0.77; P<0.001). In addition, patients who received spironolactone had a significant improvement in the symptoms of heart failure, as assessed on the basis of the New York Heart Association functional class (P<0.001). Gynecomastia or breast pain was reported in 10 percent of men who were treated with spironolactone, as compared with 1 percent of men in the placebo group (P<0.001). The incidence of serious hyperkalemia was minimal in both groups of patients. Blockade of aldosterone receptors by spironolactone, in addition to standard therapy, substantially reduces the risk of both morbidity and death among patients with severe heart failure.
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            Eplerenone in patients with systolic heart failure and mild symptoms.

            Faiez Zannad, John J V McMurray, Henry Krum … (2011)
            Mineralocorticoid antagonists improve survival among patients with chronic, severe systolic heart failure and heart failure after myocardial infarction. We evaluated the effects of eplerenone in patients with chronic systolic heart failure and mild symptoms. In this randomized, double-blind trial, we randomly assigned 2737 patients with New York Heart Association class II heart failure and an ejection fraction of no more than 35% to receive eplerenone (up to 50 mg daily) or placebo, in addition to recommended therapy. The primary outcome was a composite of death from cardiovascular causes or hospitalization for heart failure. The trial was stopped prematurely, according to prespecified rules, after a median follow-up period of 21 months. The primary outcome occurred in 18.3% of patients in the eplerenone group as compared with 25.9% in the placebo group (hazard ratio, 0.63; 95% confidence interval [CI], 0.54 to 0.74; P<0.001). A total of 12.5% of patients receiving eplerenone and 15.5% of those receiving placebo died (hazard ratio, 0.76; 95% CI, 0.62 to 0.93; P=0.008); 10.8% and 13.5%, respectively, died of cardiovascular causes (hazard ratio, 0.76; 95% CI, 0.61 to 0.94; P=0.01). Hospitalizations for heart failure and for any cause were also reduced with eplerenone. A serum potassium level exceeding 5.5 mmol per liter occurred in 11.8% of patients in the eplerenone group and 7.2% of those in the placebo group (P<0.001). Eplerenone, as compared with placebo, reduced both the risk of death and the risk of hospitalization among patients with systolic heart failure and mild symptoms. (Funded by Pfizer; ClinicalTrials.gov number, NCT00232180.).
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              Medical Therapy for Heart Failure With Reduced Ejection Fraction

              Adam D. DeVore, Puza Sharma, Carol I. Duffy … (2018)
              Guidelines strongly recommend patients with heart failure with reduced ejection fraction (HFrEF) be treated with multiple medications proven to improve clinical outcomes, as tolerated. The degree to which gaps in medication use and dosing persist in contemporary outpatient practice is unclear.
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                Author and article information

                Contributors
                Milton Packer:
                ORCID: https://orcid.org/0000-0003-1828-2387
                Journal
                Journal ID (nlm-ta): Eur Heart J
                Journal ID (iso-abbrev): Eur Heart J
                Journal ID (publisher-id): eurheartj
                Title: European Heart Journal
                Publisher: Oxford University Press (US )
                ISSN (Print): 0195-668X
                ISSN (Electronic): 1522-9645
                Publication date Collection: 01 November 2022
                Publication date (Electronic): 23 August 2022
                Publication date PMC-release: 23 August 2022
                Volume: 43
                Issue: 41 , Focus Issue on Clinical Trials
                Pages: 4374-4377
                Affiliations
                Baylor Heart and Vascular Institute , 621 North Hall Street, Dallas, TX 75226, USA
                Imperial College , London, UK
                Author notes

                The opinions expressed in this article are not necessarily those of the Editors of the European Heart Journal or of the European Society of Cardiology.

                Corresponding author. Tel: +1 214 820 7500, Email: milton.packer@ 123456baylorhealth.edu

                Conflict of interest: M.P. reports receiving fees from Abbvie, Altimmune, Amarin, Amgen, Ardelyx, AstraZeneca, Boehringer Ingelheim, Caladrius, Casana, CSL Behring, Cytokinetics, Imara, Lilly, Moderna, Novartis, Reata, Relypsa, and Salamandra.

                Author information
                https://orcid.org/0000-0003-1828-2387
                Article
                Publisher ID: ehac399
                DOI: 10.1093/eurheartj/ehac399
                PMC ID: 9622298
                PubMed ID: 35900836
                SO-VID: 1c128e6f-64fe-49a9-9716-0816909ee2da
                Copyright © © The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Cardiology.
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License ( https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

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                Pages: 4
                Categories
                Subject: Editorial
                Subject: AcademicSubjects/MED00200

                ScienceOpen disciplines: Cardiovascular Medicine
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                ScienceOpen disciplines: Cardiovascular Medicine

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