Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes.

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Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes.

Wiviott, Stephen D (author)

Raz, Itamar (author)

Bonaca, Marc P (author)

Mosenzon, Ofri (author)

Kato, Eri T (author)

Cahn, Avivit (author)

Silverman, Michael G (author)

Zelniker, Thomas A (author)

Kuder, Julia F (author)

Murphy, Sabina A (author)

Bhatt, Deepak L (author)

Leiter, Lawrence A (author)

McGuire, Darren K (author)

Wilding, John P H (author)

Ruff, Christian T (author)

Gause-Nilsson, Ingrid A M (author)

Fredriksson, Martin (author)

Johansson, Peter A (author)

Langkilde, Anna-Maria (author)

Sabatine, Marc S (author)

Dellborg, Mikael, 1954 (author): Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för molekylär och klinisk medicin,Institute of Medicine, Department of Molecular and Clinical Medicine

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2019
2019
English.
In: The New England journal of medicine. - 1533-4406. ; 380:4, s. 347-357

Related links:: https://gup.ub.gu.se...; show more...; https://doi.org/10.1...; show less...

Journal article (peer-reviewed)

Abstract Subject headings

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 .).

Subject headings

MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine (hsv//eng)

Keyword

Aged
Benzhydryl Compounds
adverse effects
therapeutic use
Cardiovascular Diseases
etiology
mortality
prevention & control
Diabetes Mellitus
Type 2
complications
drug therapy
Female
Glucosides
adverse effects
therapeutic use
Heart Failure
epidemiology
Hospitalization
statistics & numerical data
Humans
Male
Middle Aged
Sodium-Glucose Transporter 2 Inhibitors
adverse effects
therapeutic use

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ref (subject category)
art (subject category)

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