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Dapagliflozin and C...
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Wiviott, Stephen D
(författare)
Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes.
- Artikel/kapitelEngelska2019
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Nummerbeteckningar
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LIBRIS-ID:oai:gup.ub.gu.se/279412
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https://gup.ub.gu.se/publication/279412URI
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https://doi.org/10.1056/NEJMoa1812389DOI
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Ämneskategori:art swepub-publicationtype
Anmärkningar
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The cardiovascular safety profile of dapagliflozin, a selective inhibitor of sodium-glucose cotransporter 2 that promotes glucosuria in patients with type 2 diabetes, is undefined.We randomly assigned patients with type 2 diabetes who had or were at risk for atherosclerotic cardiovascular disease to receive either dapagliflozin or placebo. The primary safety outcome was a composite of major adverse cardiovascular events (MACE), defined as cardiovascular death, myocardial infarction, or ischemic stroke. The primary efficacy outcomes were MACE and a composite of cardiovascular death or hospitalization for heart failure. Secondary efficacy outcomes were a renal composite (≥40% decrease in estimated glomerular filtration rate to <60 ml per minute per 1.73 m2 of body-surface area, new end-stage renal disease, or death from renal or cardiovascular causes) and death from any cause.We evaluated 17,160 patients, including 10,186 without atherosclerotic cardiovascular disease, who were followed for a median of 4.2 years. In the primary safety outcome analysis, dapagliflozin met the prespecified criterion for noninferiority to placebo with respect to MACE (upper boundary of the 95% confidence interval [CI], <1.3; P<0.001 for noninferiority). In the two primary efficacy analyses, dapagliflozin did not result in a lower rate of MACE (8.8% in the dapagliflozin group and 9.4% in the placebo group; hazard ratio, 0.93; 95% CI, 0.84 to 1.03; P=0.17) but did result in a lower rate of cardiovascular death or hospitalization for heart failure (4.9% vs. 5.8%; hazard ratio, 0.83; 95% CI, 0.73 to 0.95; P=0.005), which reflected a lower rate of hospitalization for heart failure (hazard ratio, 0.73; 95% CI, 0.61 to 0.88); there was no between-group difference in cardiovascular death (hazard ratio, 0.98; 95% CI, 0.82 to 1.17). A renal event occurred in 4.3% in the dapagliflozin group and in 5.6% in the placebo group (hazard ratio, 0.76; 95% CI, 0.67 to 0.87), and death from any cause occurred in 6.2% and 6.6%, respectively (hazard ratio, 0.93; 95% CI, 0.82 to 1.04). Diabetic ketoacidosis was more common with dapagliflozin than with placebo (0.3% vs. 0.1%, P=0.02), as was the rate of genital infections that led to discontinuation of the regimen or that were considered to be serious adverse events (0.9% vs. 0.1%, P<0.001).In patients with type 2 diabetes who had or were at risk for atherosclerotic cardiovascular disease, treatment with dapagliflozin did not result in a higher or lower rate of MACE than placebo but did result in a lower rate of cardiovascular death or hospitalization for heart failure, a finding that reflects a lower rate of hospitalization for heart failure. (Funded by AstraZeneca; DECLARE-TIMI 58 ClinicalTrials.gov number, NCT01730534 .).
Ämnesord och genrebeteckningar
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MEDICIN OCH HÄLSOVETENSKAP Klinisk medicin hsv//swe
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MEDICAL AND HEALTH SCIENCES Clinical Medicine hsv//eng
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Aged
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Benzhydryl Compounds
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adverse effects
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therapeutic use
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Cardiovascular Diseases
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etiology
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mortality
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prevention & control
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Diabetes Mellitus
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Type 2
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complications
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drug therapy
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Female
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Glucosides
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adverse effects
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therapeutic use
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Heart Failure
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epidemiology
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Hospitalization
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statistics & numerical data
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Humans
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Male
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Middle Aged
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Sodium-Glucose Transporter 2 Inhibitors
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adverse effects
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therapeutic use
Biuppslag (personer, institutioner, konferenser, titlar ...)
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Raz, Itamar
(författare)
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Bonaca, Marc P
(författare)
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Mosenzon, Ofri
(författare)
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Kato, Eri T
(författare)
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Cahn, Avivit
(författare)
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Silverman, Michael G
(författare)
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Zelniker, Thomas A
(författare)
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Kuder, Julia F
(författare)
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Murphy, Sabina A
(författare)
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Bhatt, Deepak L
(författare)
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Leiter, Lawrence A
(författare)
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McGuire, Darren K
(författare)
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Wilding, John P H
(författare)
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Ruff, Christian T
(författare)
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Gause-Nilsson, Ingrid A M
(författare)
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Fredriksson, Martin
(författare)
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Johansson, Peter A
(författare)
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Langkilde, Anna-Maria
(författare)
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Sabatine, Marc S
(författare)
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Dellborg, Mikael,1954Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för molekylär och klinisk medicin,Institute of Medicine, Department of Molecular and Clinical Medicine(Swepub:gu)xdelmi
(författare)
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Göteborgs universitetInstitutionen för medicin, avdelningen för molekylär och klinisk medicin
(creator_code:org_t)
Sammanhörande titlar
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Ingår i:The New England journal of medicine380:4, s. 347-3571533-4406
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Wiviott, Stephen ...
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Raz, Itamar
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Bonaca, Marc P
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Mosenzon, Ofri
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Kato, Eri T
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Cahn, Avivit
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Silverman, Micha ...
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Zelniker, Thomas ...
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Kuder, Julia F
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Murphy, Sabina A
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Bhatt, Deepak L
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McGuire, Darren ...
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Wilding, John P ...
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Ruff, Christian ...
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Gause-Nilsson, I ...
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Fredriksson, Mar ...
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Johansson, Peter ...
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Langkilde, Anna- ...
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Sabatine, Marc S
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Dellborg, Mikael ...
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