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• W2918530247 abstract "HomeCirculationVol. 139, No. 11Empagliflozin Is Associated With a Lower Risk of Post-Acute Heart Failure Rehospitalization and Mortality Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessLetterPDF/EPUBEmpagliflozin Is Associated With a Lower Risk of Post-Acute Heart Failure Rehospitalization and MortalityInsights From the EMPA-REG OUTCOME Trial Gianluigi Savarese, MD, PhD, Naveed Sattar, MD, PhD, James Januzzi, MD, Subodh Verma, MD, PhD, Lars H. Lund, MD, PhD, David Fitchett, MD, Cordula Zeller, Dipl Math, Jyothis T. George, MD, Martina Brueckmann, MD, Anne Pernille Ofstad, MD, PhD, Silvio E. Inzucchi, MD, Christoph Wanner, MD, Bernard Zinman, MD and Javed Butler, MD, MPH, MBA Gianluigi SavareseGianluigi Savarese Cardiology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden (G.S., L.H.L.). Search for more papers by this author , Naveed SattarNaveed Sattar University of Glasgow, UK (N.S.). Search for more papers by this author , James JanuzziJames Januzzi Cardiology Division, Massachusetts General Hospital, and Baim Institute for Clinical Research, Boston (J.J.). Search for more papers by this author , Subodh VermaSubodh Verma Division of Cardiac Surgery, Li Ka Shing Knowledge Institute of St. Michael’s Hospital (S.V.), University of Toronto, ON, Canada. Search for more papers by this author , Lars H. LundLars H. Lund Cardiology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden (G.S., L.H.L.). Search for more papers by this author , David FitchettDavid Fitchett St. Michael’s Hospital, Division of Cardiology (D.F.), University of Toronto, ON, Canada. Search for more papers by this author , Cordula ZellerCordula Zeller Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany (C.Z.). Search for more papers by this author , Jyothis T. GeorgeJyothis T. George Boehringer Ingelheim International GmbH, Ingelheim, Germany (J.T.G., M.B.). Search for more papers by this author , Martina BrueckmannMartina Brueckmann Boehringer Ingelheim International GmbH, Ingelheim, Germany (J.T.G., M.B.). Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany (M.B.). Search for more papers by this author , Anne Pernille OfstadAnne Pernille Ofstad Boehringer Ingelheim Norway KS, Asker, Norway (A.P.O.). Search for more papers by this author , Silvio E. InzucchiSilvio E. Inzucchi Section of Endocrinology, Yale University School of Medicine, Yale–New Haven Hospital, CT (S.E.I.). Search for more papers by this author , Christoph WannerChristoph Wanner Department of Internal Medicine I, Nephrology, University Hospital Würzburg, Germany (C.W.). Search for more papers by this author , Bernard ZinmanBernard Zinman Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital (B.Z.), University of Toronto, ON, Canada. Search for more papers by this author and Javed ButlerJaved Butler Javed Butler, MD, MPH, MBA, University of Mississippi Medical Center, Department of Medicine (L650), 2500 N State St, Jackson, MS 39216. Email E-mail Address: [email protected] Department of Medicine, University of Mississippi, Jackson (J.B.). Search for more papers by this author Originally published11 Mar 2019https://doi.org/10.1161/CIRCULATIONAHA.118.038339Circulation. 2019;139:1458–1460Despite treatment advances for heart failure (HF) with reduced ejection fraction, overall, patients with HF continue to be at high risk for mortality and repeat hospitalizations. The post-acute HF time course, a period after hospitalization for HF, called the vulnerable phase, is a particularly high-risk time, marked by risk for rehospitalization of >50% within 6 months or death.1 HF inflicts a considerable financial burden on healthcare systems, with hospitalizations accounting for the majority of costs. In some countries such as the United States, performance measures tied to reimbursement now focus on reducing early readmissions. Accordingly, therapies improving outcomes in the short time after hospitalization are needed.In the EMPA-REG OUTCOME trial (BI 10773 [Empagliflozin] Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients), treatment with empagliflozin reduced the risk of HF hospitalization by 35% compared with placebo in patients with type 2 diabetes mellitus and established cardiovascular disease, regardless of HF status at baseline.2 The aim of this post hoc analysis of the EMPA-REG OUTCOME trial was to investigate the effect of short-term outcomes with empagliflozin after an initial HF hospitalization.The design and results of the EMPA-REG OUTCOME trial have previously been published.2 Briefly, patients with type 2 diabetes mellitus and cardiovascular disease with an estimated glomerular filtration rate of at least 30 mL·min−1·1.73 m−2 were randomized 1:1:1 to empagliflozin 10 or 25 mg or placebo on top of standard of care. We previously reported the number of recurrent HF hospitalizations over the totality of the study period.3 Here, we focus on specific time windows after initial HF hospitalization. We selected patients who experienced ≥1 HF hospitalization after randomization and assessed the number of adjudicated clinical events (second events of HF rehospitalization, HF rehospitalization or cardiovascular death, HF rehospitalization or all-cause death) within 30, 45, 60, and 90 days from the admission date of first HF hospitalization in the empagliflozin versus placebo arms. An independent ethics committee or institutional review board approved the clinical protocol at each participating center. All patients provided written informed consent.Of 7020 treated patients, 221 were hospitalized for HF at least once, including 126 of 4687 (2.7%) assigned to empagliflozin and 95 of 2333 (4.1%) receiving placebo. In this subgroup of patients hospitalized for HF, baseline mean age was 66±8 years, 29% were female, and mean estimated glomerular filtration rate was 64.5 mL·min−1·1.73 m−2; patient characteristics were overall comparable across the treatment arms. The percentage of patients with a second HF readmission within 30 days from the first HF admission was similar between the empagliflozin (4.0%) and placebo (4.2%) groups, whereas rates at 45, 60, and 90 days were nearly 2-fold higher in placebo- versus empagliflozin-treated patients (Figure). The percentages of patients with HF rehospitalization or cardiovascular death and HF rehospitalization or all-cause death were ≈2-fold higher in placebo- versus empagliflozin-treated patients at all time points considered (30, 45, 60, and 90 days; Figure).Download figureDownload PowerPointFigure. Cardiovascular (CV) events after index heart failure (HF) hospitalization in the EMPA-REG OUTCOME trial (BI 10773 [Empagliflozin] Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients). Rates of HF rehospitalization (second events) and HF rehospitalization, cardiovascular mortality, or all-cause mortality by time windows (30, 45, 60, 90 days) from the admission date of first HF hospitalization (A) and Kaplan–Meier curve of time to cardiovascular death or HF rehospitalization (B). A total of n=221 patients with index hospitalization were evaluated (126 receiving empagliflozin and 95 receiving placebo).Repeated hospitalizations are associated with high mortality in patients with HF, and they drive the high HF costs.4 Reducing early and repeated HF readmissions during the post-acute HF period is important for both clinical and healthcare economics purposes, benefiting a vulnerable patient population during a very high-risk period. Our analysis showed lower rates of HF readmission and the composite outcomes of HF readmission and cardiovascular or all-cause death in patients treated with empagliflozin after an index HF hospitalization. Potential mechanisms for this observed potential benefit of empagliflozin may include osmotic diuresis, natriuresis, improvement in cardiac energetics, or direct actions on cardiomyocytes.5The main limitation of this analysis was that patients were not randomized to empagliflozin versus placebo at the time of the first HF hospitalization, and the treatment allocation affected the first HF hospitalization. Thus, given that statistical testing cannot fully balance the consequent source of bias, we have provided descriptive statistics only. In addition, outcomes data are related to days from the day of admission and not discharge because discharge dates were not collected in the EMPA-REG OUTCOME trial. Thus, the 45-day outcomes are 45 days from admission but less from discharge.In conclusion, treatment with empagliflozin may play a role in reducing risk in the post-acute HF period, with a significant early impact on HF hospital readmissions and mortality. The ongoing EMPEROR (Empagliflozin Outcome Trial in Patients With Chronic Heart Failure) trials (EMPEROR-Reduced [Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Reduced Ejection Fraction], NCT03057977; and EMPEROR-Preserved [Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Preserved Ejection Fraction], NCT03057951), enrolling patients with established HF with preserved and reduced ejection fraction with and without diabetes mellitus, will provide further information on the effect of empagliflozin on first and recurrent HF events. Other trials with sodium-glucose cotransporter 2/1 inhibition will also examine the effects in patients with type 2 diabetes mellitus and acute/worsening HF (SOLOIST-WHF [Effect of Sotagliflozin on Cardiovascular Events in Patients With Type 2 Diabetes Post Worsening Heart Failure], NCT03521934). The current data presented here, albeit post hoc, provide a cogent rationale for studying sodium-glucose cotransporter 2 inhibitors specifically in patients hospitalized with decompensated HF.Sources of FundingThe EMPA-REG OUTCOME trial was funded by the Boehringer Ingelheim & Eli Lilly and Company Diabetes Alliance.DisclosuresDr Butler has received research support from the National Institutes of Health, Patient-Centered Outcomes Research Institute, and the European Union. He serves on the speakers’ bureau for Novartis, Janssen, and Novo Nordisk. He serves as a consultant for Abbott, Adrenomed, Amgen, Array, AstraZeneca, Bayer, BerlinCures, Boehringer Ingelheim, Bristol-Myers Squibb, CardioCell, CVRx, G3 Pharmaceutical, Innolife, Janssen, Lantheus, LivaNova, Luitpold, Medtronic, Merck, Novartis, Novo Nordisk, Relypsa, Roche, Sanofi, StealthPeptide, SC Pharma, V-Wave Limited, Vifor, and ZS Pharma. Dr Savarese is a fellow of the Cardiovascular Clinical Trialists Forum, which received an unrestricted grant from Boehringer Ingelheim. He has received research grants from Boehringer Ingelheim and Merck Sharp & Dohme, as well as honoraria and personal fees from AstraZeneca, Roche, Servier, and Vifor. Dr Sattar has consulted for or received speaker’s honoraria from Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, NAPP Pharmaceuticals, Novo Nordisk, and Sanofi and grant support from Boehringer Ingelheim. Dr Januzzi reports grants from Roche Diagnostics, Singulex, Prevencio, Abbott, and Cleveland Heart Labs; consulting fees from Roche Diagnostics, Abbott, MyoKardia, and Jana Care; and End Point Committee/Data Safety Monitoring Board income from Boehringer Ingelheim, Janssen, AbbVie, and Abbott. Dr Verma has received research grants and/or speaker honoraria from Abbott, Amgen, Boehringer Ingelheim, Bayer, AstraZeneca, Janssen, Lilly, Sanofi, Merck, and Novo Nordisk. Dr Lund reports grants and consulting fees from Novartis, Boehringer Ingelheim and AstraZeneca, as well as consulting fees from Sanofi and Vifor Pharma. Dr Fitchett has consulted for or received speaker’s honoraria from Boehringer Ingelheim, Eli Lilly, AstraZeneca, Amgen, and Sanofi and served on clinical trial committees for Novo Nordisk. C. Zeller, Dr George, Dr Brueckmann, and Dr Ofstad are employees of Boehringer Ingelheim. Dr Inzucchi has been a consultant to vTv Therapeutics and has served on Clinical Trial Steering/Executive Committees for Boehringer Ingelheim, AstraZeneca, Novo Nordisk, and Sanofi/Lexicon. Dr Wanner reports serving on Advisory Boards for Bayer, Boehringer Ingelheim, and Merck and receiving speaker’s honoraria from Boehringer Ingelheim, Merck Sharp & Dohme, Eli Lilly, and AstraZeneca. Dr Zinman has served on the Advisory Board for Boehringer Ingelheim, Janssen, Novo Nordisk, Merck, Eli Lilly, and Sanofi. The other authors report no conflicts.Footnoteshttps://www.ahajournals.org/journal/circGuest Editor for this article was Gilbert Perry, MD.Data Sharing: The data that support the findings of this analysis are available from the corresponding author on reasonable request.Javed Butler, MD, MPH, MBA, University of Mississippi Medical Center, Department of Medicine (L650), 2500 N State St, Jackson, MS 39216. Email [email protected]eduReferences1. 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Verma S, Sharma A, Kanumilli N and Butler J (2019) Predictors of heart failure development in type 2 diabetes, Current Opinion in Cardiology, 10.1097/HCO.0000000000000647, 34:5, (578-583), Online publication date: 1-Sep-2019. Valle-Munoz A, Morillas-Climent H and Vicedo-López Á (2019) Sacubitrilo-valsartán e inhibidores del cotransportador de sodio-glucosa tipo 2 en insuficiencia cardiaca: ¿separación de poderes o bienes gananciales?, Revista Española de Cardiología Suplementos, 10.1016/S1131-3587(20)30006-6, 18, (24-30), . March 12, 2019Vol 139, Issue 11 Advertisement Article InformationMetrics © 2019 American Heart Association, Inc.https://doi.org/10.1161/CIRCULATIONAHA.118.038339PMID: 30855996 Originally publishedMarch 11, 2019 Keywordshospitalizationheart failuremortalityPDF download Advertisement SubjectsDiabetes, Type 2Heart Failure" @default.
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