From the Department of Cardiology (CVK) and the Berlin Institute of Health Center for Regenerative Therapies (BCRT), German Center for Cardiovascular Research (DZHK) partner site Berlin, Charité Universitätsmedizin Berlin, Berlin (S.D.A.), Universitätsklinikum des Saarlandes, Homberg (M. Böhm), RWTH Aachen University, Aachen (N.M.), Boehringer Ingelheim Pharma, Biberach (C.Z., S.S.), Boehringer Ingelheim International, Ingelheim (W.J., M. Brueckmann), and the Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M. Brueckmann) - all in Germany; the University of Mississippi Medical Center, Jackson (J.B.); National and Kapodistrian University of Athens School of Medicine, Athens (G.F.); Université de Lorraine, INSERM, Centre d'Investigations Cliniques Plurithématique 1433, and INSERM Unité 1116, CHRU, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists) (J.P.F.), and Université de Lorraine, INSERM INI-CRCT, CHRU (F.Z.) - both in Nancy, France; the Cardiovascular Research and Development Center, Department of Surgery and Physiology, Faculty of Medicine of the University of Porto, Porto, Portugal (J.P.F.); Unidade de Insuficiência Cardíaca, Instituto do Coracao, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo (E.B.); Maastricht University Medical Center and the School for Cardiovascular Disease CARIM - both in Maastricht, the Netherlands (H.-P.B.-L.R.); the Department of Medicine, Seoul National University Bundang Hospital, Seoul, South Korea (D.-J.C.); Max Superspeciality Hospital, Saket, New Delhi, India (V.C.); the National Institute of Cardiology, Mexico City (E.C.-V.); McGill University Health Centre, Montreal (N.G.), and St. Michael's Hospital, University of Toronto, Toronto (S.V.) - both in Canada; the Cardiology Service, Fundación Valle del Lili, Universidad Icesi, Cali, Colombia (J.E.G.-M.); the Department of Cardiovascular Diseases, University Hospitals Leuven, Leuven, Belgium (S.J.); Massachusetts General Hospital and Baim Institute for Clinical Research, Boston (J.L.J.); University Hospital, Santiago de Compostela, Spain (J.R.G.-J.); Heart and Vascular Center, Semmelweiss University, Budapest, Hungary (B.M.); Victorian Heart Institute, Monash University, Melbourne, VIC, Australia (S.J.N.); Argentine Catholic University, and Medical Advisor in Heart Failure, Pulmonary Hypertension and Intrathoracic Transplant at FLENI and IADT Institute - both in Buenos Aires (S.V.P.); Central Michigan University, Mount Pleasant (I.L.P.); Wroclaw Medical University, Wroclaw, Poland (P.P.); the Cardiovascular Department, Cardiology Division, Papa Giovanni XXIII Hospital, Bergamo (M.S.), and Università di Pisa, Pisa (S.T.) - both in Italy; National Heart Centre Singapore, Singapore (D.S.); the Internal Cardiology Department, St. Ann University Hospital and Masaryk University, Brno, Czech Republic (J.S.); the University of Leicester, Glenfield General Hospital, Leicester (I.S.), the University of Glasgow, Glasgow (N.S.), the London School of Hygiene and Tropical Medicine (S.J.P.), and Imperial College, London (M.P.) - all in the United Kingdom; Kyushu University, Fukuoka, Japan (H.T.); the University of Medicine and Pharmacy, Carol Davila University and Emergency Hospital, Bucharest, Romania (D.V.); the Heart Failure Center, Fuwai Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing (J.Z.); the Veterans Affairs Medical Center, Washington, DC (P.C.); National Heart Centre Singapore, Duke-National University of Singapore, Singapore (C.S.P.L.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (J.M.S.); and Baylor Heart and Vascular Institute, Dallas (M.P.).
N Engl J Med. 2021 Oct 14;385(16):1451-1461. doi: 10.1056/NEJMoa2107038. Epub 2021 Aug 27.
BACKGROUND: Sodium-glucose cotransporter 2 inhibitors reduce the risk of hospitalization for heart failure in patients with heart failure and a reduced ejection fraction, but their effects in patients with heart failure and a preserved ejection fraction are uncertain. METHODS: In this double-blind trial, we randomly assigned 5988 patients with class II-IV heart failure and an ejection fraction of more than 40% to receive empagliflozin (10 mg once daily) or placebo, in addition to usual therapy. The primary outcome was a composite of cardiovascular death or hospitalization for heart failure. RESULTS: Over a median of 26.2 months, a primary outcome event occurred in 415 of 2997 patients (13.8%) in the empagliflozin group and in 511 of 2991 patients (17.1%) in the placebo group (hazard ratio, 0.79; 95% confidence interval [CI], 0.69 to 0.90; P<0.001). This effect was mainly related to a lower risk of hospitalization for heart failure in the empagliflozin group. The effects of empagliflozin appeared consistent in patients with or without diabetes. The total number of hospitalizations for heart failure was lower in the empagliflozin group than in the placebo group (407 with empagliflozin and 541 with placebo; hazard ratio, 0.73; 95% CI, 0.61 to 0.88; P<0.001). Uncomplicated genital and urinary tract infections and hypotension were reported more frequently with empagliflozin. CONCLUSIONS: Empagliflozin reduced the combined risk of cardiovascular death or hospitalization for heart failure in patients with heart failure and a preserved ejection fraction, regardless of the presence or absence of diabetes. (Funded by Boehringer Ingelheim and Eli Lilly; EMPEROR-Preserved ClinicalTrials.gov number, NCT03057951).
背景：钠-葡萄糖共转运蛋白 2 抑制剂可降低射血分数降低的心力衰竭患者因心力衰竭住院的风险，但它们在射血分数保留的心力衰竭患者中的作用尚不确定。
方法：在这项双盲试验中，我们将 5988 例射血分数大于 40%的 II-IV 级心力衰竭患者随机分为接受恩格列净（每日 10mg，一次）或安慰剂治疗组，同时给予常规治疗。主要终点是心血管死亡或心力衰竭住院的复合终点。
结果：中位随访 26.2 个月期间，恩格列净组 2997 例患者中有 415 例（13.8%）和安慰剂组 2991 例患者中有 511 例（17.1%）发生主要终点事件（风险比，0.79；95%置信区间[CI]，0.69 至 0.90；P<0.001）。这种效果主要与恩格列净组心力衰竭住院风险降低有关。恩格列净在有或无糖尿病的患者中效果一致。恩格列净组心力衰竭住院总次数低于安慰剂组（恩格列净组 407 例，安慰剂组 541 例；风险比，0.73；95%CI，0.61 至 0.88；P<0.001）。恩格列净组更常报告单纯性生殖道和尿路感染以及低血压。
结论：无论是否存在糖尿病，恩格列净均可降低射血分数保留的心力衰竭患者心血管死亡或心力衰竭住院的联合风险。（由勃林格殷格翰和礼来公司资助；EMPEROR-Preserved 临床试验.gov 编号，NCT03057951）。
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