PMID- 36054231 OWN - NLM STAT- MEDLINE DCOM- 20221128 LR - 20231202 IS - 1879-0844 (Electronic) IS - 1388-9842 (Print) IS - 1388-9842 (Linking) VI - 24 IP - 10 DP - 2022 Oct TI - Dapagliflozin and New York Heart Association functional class in heart failure with mildly reduced or preserved ejection fraction: the DELIVER trial. PG - 1892-1901 LID - 10.1002/ejhf.2652 [doi] AB - AIMS: This pre-specified analysis of the DELIVER trial examined whether clinical benefits of dapagliflozin in heart failure (HF) with left ventricular ejection fraction (LVEF) >40% varied by baseline New York Heart Association (NYHA) class and examined the treatment effects on NYHA class over time. METHODS AND RESULTS: Treatment effects of dapagliflozin by baseline NYHA class II (n = 4713) versus III/IV (n = 1549) were examined on the primary endpoint (cardiovascular death or worsening HF event) and key secondary endpoints. Effects of dapagliflozin on change in NYHA class at 4, 16, and 32 weeks were also evaluated. Higher baseline NYHA class was associated with older age, female sex, greater comorbidity burden, lower LVEF, and higher natriuretic peptide levels. Participants with baseline NYHA class III/IV, as compared with II, were independently more likely to experience the primary endpoint (adjusted hazard ratio [HR] 1.16 [95% confidence interval, 1.02-1.33]) and all-cause death (adjusted HR 1.22 [1.06-1.40]). Dapagliflozin consistently reduced the risk of the primary endpoint compared with placebo, irrespective of baseline NYHA class (HR 0.81 [0.70-0.94] for NYHA class II vs. HR 0.80 [0.65-0.98] for NYHA class III/IV; p(interaction) = 0.921). Participants with NYHA class III/IV had greater improvement in Kansas City Cardiomyopathy Questionnaire total symptom scores between baseline and 32 weeks (+4.8 [2.5-7.1]) versus NYHA class II (+1.8 [0.7-2.9]; p(interaction) = 0.011). Dapagliflozin was associated with higher odds of any improvement in NYHA class (odds ratio [OR] 1.32 [1.16-1.51]), as well as improvement to NYHA class I (OR 1.43 [1.17-1.75]), versus placebo at 32 weeks, with benefits seen as early as 4 weeks. CONCLUSIONS: Among symptomatic patients with HF and LVEF >40%, treatment with dapagliflozin provided clinical benefit irrespective of baseline NYHA class and was associated with early and sustained improvements in NYHA class over time. CI - (c) 2022 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology. FAU - Ostrominski, John W AU - Ostrominski JW AUID- ORCID: 0000-0002-2866-9414 AD - Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. FAU - Vaduganathan, Muthiah AU - Vaduganathan M AUID- ORCID: 0000-0003-0885-1953 AD - Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. FAU - Claggett, Brian L AU - Claggett BL AD - Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. FAU - de Boer, Rudolf A AU - de Boer RA AUID- ORCID: 0000-0002-4775-9140 AD - Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. FAU - Desai, Akshay S AU - Desai AS AUID- ORCID: 0000-0002-1443-0701 AD - Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. FAU - Dobreanu, Dan AU - Dobreanu D AD - University of Medicine, Pharmacy, Science and Technology "G.E. Palade", Targu Mures, Romania. FAU - Hernandez, Adrian F AU - Hernandez AF AD - Department of Medicine, Duke University, Durham, NC, USA. AD - Duke Clinical Research Institute, Duke University, Durham, NC, USA. FAU - Inzucchi, Silvio E AU - Inzucchi SE AD - Section of Endocrinology, Yale University School of Medicine, New Haven, CT, USA. FAU - Jhund, Pardeep S AU - Jhund PS AUID- ORCID: 0000-0003-4306-5317 AD - British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK. FAU - Kosiborod, Mikhail AU - Kosiborod M AD - St Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, MI, USA. FAU - Lam, Carolyn S P AU - Lam CSP AD - Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. AD - National Heart Centre Singapore and Duke-National University of Singapore, Singapore, Singapore. FAU - Langkilde, Anna M AU - Langkilde AM AD - Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, Gothenburg, Sweden. FAU - Lindholm, Daniel AU - Lindholm D AD - Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, Gothenburg, Sweden. FAU - Martinez, Felipe A AU - Martinez FA AD - Universidad Nacional de Cordoba, Cordoba, Argentina. FAU - O'Meara, Eileen AU - O'Meara E AD - Institut de Cardiologie de Montreal, Universite de Montreal, Montreal, Quebec, Canada. FAU - Petersson, Magnus AU - Petersson M AD - Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, Gothenburg, Sweden. FAU - Shah, Sanjiv J AU - Shah SJ AUID- ORCID: 0000-0002-5655-8201 AD - Feinberg Cardiovascular Research Institute, Northwestern University Feinberg School of Medicine, Chicago, IL, USA. FAU - Thierer, Jorge AU - Thierer J AD - Jefe de Unidad de Insuficiencia Cardiaca, Centro de Education Medica e Investigaciones Clinicas Norberto Quirno (CEMIC), Buenos Aires, Argentina. FAU - McMurray, John J V AU - McMurray JJV AUID- ORCID: 0000-0002-6317-3975 AD - British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK. FAU - Solomon, Scott D AU - Solomon SD AD - Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. LA - eng GR - P30 DK045735/DK/NIDDK NIH HHS/United States PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20220827 PL - England TA - Eur J Heart Fail JT - European journal of heart failure JID - 100887595 RN - 1ULL0QJ8UC (dapagliflozin) SB - IM CIN - Eur J Heart Fail. 2022 Oct;24(10):1902-1905. PMID: 36097872 MH - Humans MH - Female MH - Stroke Volume MH - *Heart Failure MH - Ventricular Function, Left MH - New York PMC - PMC9804680 OTO - NOTNLM OT - Dapagliflozin OT - Functional status OT - Heart failure with preserved ejection fraction OT - New York Heart Association classification EDAT- 2022/09/03 06:00 MHDA- 2022/11/29 06:00 PMCR- 2022/12/31 CRDT- 2022/09/02 13:44 PHST- 2022/08/01 00:00 [revised] PHST- 2022/07/23 00:00 [received] PHST- 2022/08/06 00:00 [accepted] PHST- 2022/09/03 06:00 [pubmed] PHST- 2022/11/29 06:00 [medline] PHST- 2022/09/02 13:44 [entrez] PHST- 2022/12/31 00:00 [pmc-release] AID - EJHF2652 [pii] AID - 10.1002/ejhf.2652 [doi] PST - ppublish SO - Eur J Heart Fail. 2022 Oct;24(10):1892-1901. doi: 10.1002/ejhf.2652. Epub 2022 Aug 27.