Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction
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Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. / McMurray, John J V; Solomon, Scott D; Inzucchi, Silvio E; Køber, Lars; Kosiborod, Mikhail N; Martinez, Felipe A; Ponikowski, Piotr; Sabatine, Marc S; Anand, Inder S; Bělohlávek, Jan; Böhm, Michael; Chiang, Chern-En; Chopra, Vijay K; de Boer, Rudolf A; Desai, Akshay S; Diez, Mirta; Drozdz, Jaroslaw; Dukát, Andrej; Ge, Junbo; Howlett, Jonathan G; Katova, Tzvetana; Kitakaze, Masafumi; Ljungman, Charlotta E A; Merkely, Béla; Nicolau, Jose C; O'Meara, Eileen; Petrie, Mark C; Vinh, Pham N; Schou, Morten; Tereshchenko, Sergey; Verma, Subodh; Held, Claes; DeMets, David L; Docherty, Kieran F; Jhund, Pardeep S; Bengtsson, Olof; Sjöstrand, Mikaela; Langkilde, Anna-Maria; DAPA-HF Trial Committees and Investigators.
I: The New England Journal of Medicine, Bind 381, Nr. 21, 2019, s. 1995-2008.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction
AU - McMurray, John J V
AU - Solomon, Scott D
AU - Inzucchi, Silvio E
AU - Køber, Lars
AU - Kosiborod, Mikhail N
AU - Martinez, Felipe A
AU - Ponikowski, Piotr
AU - Sabatine, Marc S
AU - Anand, Inder S
AU - Bělohlávek, Jan
AU - Böhm, Michael
AU - Chiang, Chern-En
AU - Chopra, Vijay K
AU - de Boer, Rudolf A
AU - Desai, Akshay S
AU - Diez, Mirta
AU - Drozdz, Jaroslaw
AU - Dukát, Andrej
AU - Ge, Junbo
AU - Howlett, Jonathan G
AU - Katova, Tzvetana
AU - Kitakaze, Masafumi
AU - Ljungman, Charlotta E A
AU - Merkely, Béla
AU - Nicolau, Jose C
AU - O'Meara, Eileen
AU - Petrie, Mark C
AU - Vinh, Pham N
AU - Schou, Morten
AU - Tereshchenko, Sergey
AU - Verma, Subodh
AU - Held, Claes
AU - DeMets, David L
AU - Docherty, Kieran F
AU - Jhund, Pardeep S
AU - Bengtsson, Olof
AU - Sjöstrand, Mikaela
AU - Langkilde, Anna-Maria
AU - DAPA-HF Trial Committees and Investigators
PY - 2019
Y1 - 2019
N2 - BACKGROUND: In patients with type 2 diabetes, inhibitors of sodium-glucose cotransporter 2 (SGLT2) reduce the risk of a first hospitalization for heart failure, possibly through glucose-independent mechanisms. More data are needed regarding the effects of SGLT2 inhibitors in patients with established heart failure and a reduced ejection fraction, regardless of the presence or absence of type 2 diabetes.METHODS: In this phase 3, placebo-controlled trial, we randomly assigned 4744 patients with New York Heart Association class II, III, or IV heart failure and an ejection fraction of 40% or less to receive either dapagliflozin (at a dose of 10 mg once daily) or placebo, in addition to recommended therapy. The primary outcome was a composite of worsening heart failure (hospitalization or an urgent visit resulting in intravenous therapy for heart failure) or cardiovascular death.RESULTS: Over a median of 18.2 months, the primary outcome occurred in 386 of 2373 patients (16.3%) in the dapagliflozin group and in 502 of 2371 patients (21.2%) in the placebo group (hazard ratio, 0.74; 95% confidence interval [CI], 0.65 to 0.85; P<0.001). A first worsening heart failure event occurred in 237 patients (10.0%) in the dapagliflozin group and in 326 patients (13.7%) in the placebo group (hazard ratio, 0.70; 95% CI, 0.59 to 0.83). Death from cardiovascular causes occurred in 227 patients (9.6%) in the dapagliflozin group and in 273 patients (11.5%) in the placebo group (hazard ratio, 0.82; 95% CI, 0.69 to 0.98); 276 patients (11.6%) and 329 patients (13.9%), respectively, died from any cause (hazard ratio, 0.83; 95% CI, 0.71 to 0.97). Findings in patients with diabetes were similar to those in patients without diabetes. The frequency of adverse events related to volume depletion, renal dysfunction, and hypoglycemia did not differ between treatment groups.CONCLUSIONS: Among patients with heart failure and a reduced ejection fraction, the risk of worsening heart failure or death from cardiovascular causes was lower among those who received dapagliflozin than among those who received placebo, regardless of the presence or absence of diabetes. (Funded by AstraZeneca; DAPA-HF ClinicalTrials.gov number, NCT03036124.).
AB - BACKGROUND: In patients with type 2 diabetes, inhibitors of sodium-glucose cotransporter 2 (SGLT2) reduce the risk of a first hospitalization for heart failure, possibly through glucose-independent mechanisms. More data are needed regarding the effects of SGLT2 inhibitors in patients with established heart failure and a reduced ejection fraction, regardless of the presence or absence of type 2 diabetes.METHODS: In this phase 3, placebo-controlled trial, we randomly assigned 4744 patients with New York Heart Association class II, III, or IV heart failure and an ejection fraction of 40% or less to receive either dapagliflozin (at a dose of 10 mg once daily) or placebo, in addition to recommended therapy. The primary outcome was a composite of worsening heart failure (hospitalization or an urgent visit resulting in intravenous therapy for heart failure) or cardiovascular death.RESULTS: Over a median of 18.2 months, the primary outcome occurred in 386 of 2373 patients (16.3%) in the dapagliflozin group and in 502 of 2371 patients (21.2%) in the placebo group (hazard ratio, 0.74; 95% confidence interval [CI], 0.65 to 0.85; P<0.001). A first worsening heart failure event occurred in 237 patients (10.0%) in the dapagliflozin group and in 326 patients (13.7%) in the placebo group (hazard ratio, 0.70; 95% CI, 0.59 to 0.83). Death from cardiovascular causes occurred in 227 patients (9.6%) in the dapagliflozin group and in 273 patients (11.5%) in the placebo group (hazard ratio, 0.82; 95% CI, 0.69 to 0.98); 276 patients (11.6%) and 329 patients (13.9%), respectively, died from any cause (hazard ratio, 0.83; 95% CI, 0.71 to 0.97). Findings in patients with diabetes were similar to those in patients without diabetes. The frequency of adverse events related to volume depletion, renal dysfunction, and hypoglycemia did not differ between treatment groups.CONCLUSIONS: Among patients with heart failure and a reduced ejection fraction, the risk of worsening heart failure or death from cardiovascular causes was lower among those who received dapagliflozin than among those who received placebo, regardless of the presence or absence of diabetes. (Funded by AstraZeneca; DAPA-HF ClinicalTrials.gov number, NCT03036124.).
KW - Aged
KW - Benzhydryl Compounds/adverse effects
KW - Cardiovascular Agents/therapeutic use
KW - Cardiovascular Diseases/mortality
KW - Combined Modality Therapy
KW - Diabetes Mellitus, Type 2/blood
KW - Drug Therapy, Combination
KW - Female
KW - Glucosides/adverse effects
KW - Glycated Hemoglobin A/analysis
KW - Heart Failure/complications
KW - Hospitalization
KW - Humans
KW - Kaplan-Meier Estimate
KW - Male
KW - Middle Aged
KW - Sodium-Glucose Transporter 2 Inhibitors/adverse effects
KW - Stroke Volume/drug effects
KW - Ventricular Dysfunction, Left/complications
U2 - 10.1056/NEJMoa1911303
DO - 10.1056/NEJMoa1911303
M3 - Journal article
C2 - 31535829
VL - 381
SP - 1995
EP - 2008
JO - New England Journal of Medicine
JF - New England Journal of Medicine
SN - 0028-4793
IS - 21
ER -
ID: 232975712