Cover & TOC
Document type
články
články
Document record
Source: BMČ - články
Title
Effect of Dapagliflozin on Worsening Heart Failure and Cardiovascular Death in Patients With Heart Failure With and Without Diabetes / MC. Petrie, S. Verma, KF. Docherty, SE. Inzucchi, I. Anand, J. Belohlávek, M. Böhm, CE. Chiang, VK. Chopra, RA. de Boer, AS. Desai, M. Diez, J. Drozdz, A. Dukát, J. Ge, J. Howlett, T. Katova, M. Kitakaze, CEA. Ljungman, B. Merkely, JC. Nicolau, E. O'Meara, PN. Vinh, M. Schou, S. Tereshchenko, L. Køber, MN. Kosiborod, AM. Langkilde, FA. Martinez, P. Ponikowski, MS. Sabatine, M. Sjöstrand, SD. Solom
Author
Petrie, Mark C
British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.

Verma, Subodh
Division of Cardiac Surgery, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.

Docherty, Kieran F
British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.

Inzucchi, Silvio E
Section of Endocrinology, Yale University School of Medicine, New Haven, Connecticut.

Anand, Inder
Department of Cardiology, University of Minnesota, Minneapolis.

Bělohlávek, Jan
Second Department of Internal Medicine, Cardiovascular Medicine, General Teaching Hospital, First Faculty of Medicine, Charles University, Prague, Czech Republic.

Böhm, Michael
Department of Medicine, Saarland University Hospital, Homburg/Saar, Germany.

Chiang, Chern-En
Division of Cardiology, Taipei Veterans General Hospital, Taipei, Taiwan. National Yang-Ming University, Taipei, Taiwan.

Chopra, Vijay K
Department of Cardiology, Medanta, Gurgaon, Haryana, India.

de Boer, Rudolf A
Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.

Desai, Akshay S
Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.

Diez, Mirta
Division of Cardiology, Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina.

Drozdz, Jaroslaw
Department Cardiology, Medical University of Lodz, Lodz, Poland.

Dukát, Andre
Fifth Department of Internal Medicine, Comenius University in Bratislava, Bratislava, Slovakia.

Ge, Junbo
Shanghai Institute of Cardiovascular Disease, Department of Cardiology, Zhongshan Hospital Fudan University, Shanghai, China.

Howlett, Jonathan
Libin Cardiovascular Institute, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.

Katova, Tzvetana
Clinic of Cardiology, National Cardiology Hospital, Sofia, Bulgaria.

Kitakaze, Masafumi
Cardiovascular Division of Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.

Ljungman, Charlotta E A
Institute of Medicine, Department of Molecular and Clinical Medicine/Cardiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.

Merkely, Bela
Heart and Vascular Center, Semmelweis University, Budapest, Hungary.

Nicolau, Jose C
Instituto do Coracao (InCor), Hospital das Clínicas Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.

O'Meara, Eileen
Department of Cardiology, Montreal Heart Institute, Montreal, Ontario, Canada.

Vinh, Pham Nguyen
Department of Internal Medicine, Tan Tao University, Tan Duc, Vietnam.

Schou, Morten
Department of Cardiology, Gentofte University Hospital Copenhagen, Copenhagen, Denmark.

Tereshchenko, Sergey
Department of Myocardial Disease and Heart Failure, National Medical Research Center of Cardiology, Moscow, Russia.

Kober, Lars
Department of Cardiology Copenhagen University Hospital, Copenhagen, Denmark.

Kosiborod, Mikhail N
St Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City.

Langkilde, Anna Maria
Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.

Martinez, Felipe A
Universidad Nacional de Córdoba, Córdoba, Argentina.

Ponikowski, Piotr
Center for Heart Diseases, University Hospital, Wroclaw Medical University, Wroclaw, Poland.

Sabatine, Marc S
Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.

Sjöstrand, Mikaela
Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.

Solomon, Scott D
Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.

Johanson, Per
Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.

Greasley, Peter J
Early Discovery and Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.

Boulton, David
Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland.

Bengtsson, Olof
Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.

Jhund, Pardeep S
British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.

McMurray, John J V
British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.

Cited source
JAMA (Chicago, Ill.). 2020, roč. 323, č. 14, s. 1353-1368. ISSN: 0098-7484; 1538-3598 (elektronická verze).
Date of issue
2020
Language
angličtina
Country
Spojené státy americké
Document type
články
DOI
Grant number
P30 DK045735 (NIDDK NIH HHS)     vyhledat publikace
Pubmed ID
Link
Record number
bmc20028265
Persistent link
MESH descriptor
glifloziny (škodlivé účinky, terapeutické užití)
staří
benzhydrylové sloučeniny (škodlivé účinky, terapeutické užití)
kardiovaskulární nemoci (mortalita)
diabetes mellitus 2. typu (krev, komplikace, farmakoterapie)
dvojitá slepá metoda
ženské pohlaví
glukosidy (škodlivé účinky, terapeutické užití)
srdeční selhání (komplikace, farmakoterapie, patofyziologie)
glykovaný hemoglobin A (analýza)
lidé
hypoglykemika (terapeutické užití)
mužské pohlaví
lidé středního věku
placeba (terapeutické užití)
tepový objem (účinky léků)
dysfunkce levé srdeční komory (farmakoterapie)
Genre
English Abstract
Importance: Additional treatments are needed for heart failure with reduced ejection fraction (HFrEF). Sodium-glucose cotransporter 2 (SGLT2) inhibitors may be an effective treatment for patients with HFrEF, even those without diabetes. Objective: To evaluate the effects of dapagliflozin in patients with HFrEF with and without diabetes. Design, Setting, and Participants: Exploratory analysis of a phase 3 randomized trial conducted at 410 sites in 20 countries. Patients with New York Heart Association classification II to IV with an ejection fraction less than or equal to 40% and elevated plasma N-terminal pro B-type natriuretic peptide were enrolled between February 15, 2017, and August 17, 2018, with final follow-up on June 6, 2019. Interventions: Addition of once-daily 10 mg of dapagliflozin or placebo to recommended therapy. Main Outcomes and Measures: The primary outcome was the composite of an episode of worsening heart failure or cardiovascular death. This outcome was analyzed by baseline diabetes status and, in patients without diabetes, by glycated hemoglobin level less than 5.7% vs greater than or equal to 5.7%. Results: Among 4744 patients randomized (mean age, 66 years; 1109 [23%] women; 2605 [55%] without diabetes), 4742 completed the trial. Among participants without diabetes, the primary outcome occurred in 171 of 1298 (13.2%) in the dapagliflozin group and 231 of 1307 (17.7%) in the placebo group (hazard ratio, 0.73 [95% CI, 0.60-0.88]). In patients with diabetes, the primary outcome occurred in 215 of 1075 (20.0%) in the dapagliflozin group and 271 of 1064 (25.5%) in the placebo group (hazard ratio, 0.75 [95% CI, 0.63-0.90]) (P value for interaction = .80). Among patients without diabetes and a glycated hemoglobin level less than 5.7%, the primary outcome occurred in 53 of 438 patients (12.1%) in the dapagliflozin group and 71 of 419 (16.9%) in the placebo group (hazard ratio, 0.67 [95% CI, 0.47-0.96]). In patients with a glycated hemoglobin of at least 5.7%, the primary outcome occurred in 118 of 860 patients (13.7%) in the dapagliflozin group and 160 of 888 (18.0%) in the placebo group (hazard ratio, 0.74 [95% CI, 0.59-0.94]) (P value for interaction = .72). Volume depletion was reported as an adverse event in 7.3% of patients in the dapagliflozin group and 6.1% in the placebo group among patients without diabetes and in 7.8% of patients in the dapagliflozin group and 7.8% in the placebo group among patients with diabetes. A kidney adverse event was reported in 4.8% of patients in the dapagliflozin group and 6.0% in the placebo group among patients without diabetes and in 8.5% of patients in the dapagliflozin group and 8.7% in the placebo group among patients with diabetes. Conclusions and Relevance: In this exploratory analysis of a randomized trial of patients with HFrEF, dapagliflozin compared with placebo, when added to recommended therapy, significantly reduced the risk of worsening heart failure or cardiovascular death independently of diabetes status. Trial Registration: ClinicalTrials.gov Identifier: NCT03036124.
Clipboard
Further actions
Online access NLK