Nicolas Girerd1, Tim Collier2, Stuart Pocock2, Henry Krum3, John J McMurray4, Karl Swedberg5, Dirk J Van Veldhuisen6, John Vincent7, Bertram Pitt8, Faiez Zannad9. 1. INSERM, Centre D'Investigations Cliniques 9501, Université de Lorraine, CHU de Nancy, Institut Lorrain du Cœur et des Vaisseaux Louis Mathieu, 4 Rue du Morvan, 54500 Vandoeuvre lès Nancy, France. 2. Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK. 3. Center of Cardiovascular Research and Education in Therapeutics, Monash University, Melbourne, Australia. 4. The British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK. 5. Department of Molecular and Clinical Medicine, University of Gothenburg, Goteborg, Sweden National Heart and Lung Institute, Imperial College, London, UK. 6. Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. 7. Pfizer, New York, NY, USA. 8. School of Medicine, University of Michigan, Ann Arbor, MI, USA. 9. INSERM, Centre D'Investigations Cliniques 9501, Université de Lorraine, CHU de Nancy, Institut Lorrain du Cœur et des Vaisseaux Louis Mathieu, 4 Rue du Morvan, 54500 Vandoeuvre lès Nancy, France f.zannad@chu-nancy.fr.
Abstract
AIMS: Cardiovascular hospitalization (CVH) in patients with heart failure (HF) is associated with a high post-discharge rate of early re-admission and CV death. Eplerenone might be effective in reducing the incidence of these adverse clinical outcomes during this period. METHODS AND RESULTS: The EMPHASIS-HF trial compared eplerenone with placebo added to standard therapy in 2737 patients with New York Heart Association class II HF and left ventricular ejection fraction ≤35%. We conducted a post hoc analysis in the 2338 patients randomized within 180 days of a CVH. The interaction between the time from the qualifying CVH to randomization and the primary outcome of CV death or hospitalization for HF (HHF), as well as other secondary outcomes, was assessed in Cox survival models. Most of the qualifying CVHs were HHF (N = 1496, 64.0%), acute coronary syndromes (N = 390, 16.7%), and arrhythmias (N = 197, 7.2%). The median time of study drug initiation from qualifying CVH was 42 days. The relative rate reductions in CV death/HHF, HHF, and all-cause mortality were similar (P for interaction = 0.65, 0.44, and 0.40, respectively) whether the treatment was initiated <42 or 42+ days after qualifying CVH. Absolute rate reductions were -5.61 [-8.67, -2.55] events per 100 patient × years in the <42 days group and -3.58 [-6.37, -0.79] in the 42+ days group. The adverse effects of eplerenone were also unaffected by the time from the qualifying CVH. CONCLUSION:Eplerenone is safe, improves survival, and may prevent re-admission when initiated soon after a hospitalization for HF or acute coronary syndromes in patients with systolic HF and mild symptoms. Published on behalf of the European Society of Cardiology. All rights reserved.
RCT Entities:
AIMS: Cardiovascular hospitalization (CVH) in patients with heart failure (HF) is associated with a high post-discharge rate of early re-admission and CV death. Eplerenone might be effective in reducing the incidence of these adverse clinical outcomes during this period. METHODS AND RESULTS: The EMPHASIS-HF trial compared eplerenone with placebo added to standard therapy in 2737 patients with New York Heart Association class II HF and left ventricular ejection fraction ≤35%. We conducted a post hoc analysis in the 2338 patients randomized within 180 days of a CVH. The interaction between the time from the qualifying CVH to randomization and the primary outcome of CV death or hospitalization for HF (HHF), as well as other secondary outcomes, was assessed in Cox survival models. Most of the qualifying CVHs were HHF (N = 1496, 64.0%), acute coronary syndromes (N = 390, 16.7%), and arrhythmias (N = 197, 7.2%). The median time of study drug initiation from qualifying CVH was 42 days. The relative rate reductions in CV death/HHF, HHF, and all-cause mortality were similar (P for interaction = 0.65, 0.44, and 0.40, respectively) whether the treatment was initiated <42 or 42+ days after qualifying CVH. Absolute rate reductions were -5.61 [-8.67, -2.55] events per 100 patient × years in the <42 days group and -3.58 [-6.37, -0.79] in the 42+ days group. The adverse effects of eplerenone were also unaffected by the time from the qualifying CVH. CONCLUSION:Eplerenone is safe, improves survival, and may prevent re-admission when initiated soon after a hospitalization for HF or acute coronary syndromes in patients with systolic HF and mild symptoms. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: João Pedro Ferreira; Nicolas Girerd; Pedro Bettencourt Medeiros; Miguel Bento Ricardo; Tiago Almeida; Alexandre Rola; Faiez Zannad; Patrick Rossignol; Irene Aragão Journal: Cardiorenal Med Date: 2017-01-21 Impact factor: 2.041
Authors: João Pedro Ferreira; Nicolas Girerd; Pedro Bettencourt Medeiros; Mário Santos; Henrique Cyrne Carvalho; Paulo Bettencourt; David Kénizou; Javed Butler; Faiez Zannad; Patrick Rossignol Journal: Clin Res Cardiol Date: 2015-11-28 Impact factor: 5.460
Authors: Stefano Coiro; Nicolas Girerd; John J V McMurray; Bertram Pitt; Karl Swedberg; Dirk J van Veldhuisen; Zohra Lamiral; Patrick Rossignol; Faiez Zannad Journal: Clin Res Cardiol Date: 2021-05-06 Impact factor: 5.460