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Sub-analyses of the EMPA-REG OUTCOME trial: Empagliflozin reduces risk of cardiovascular death across all age groups in adults with type 2 diabetes


New analyses have shown risk reductions were consistent across age groups for cardiovascular outcomes, including cardiovascular death, with Empagliflozin ( Jardiance ) compared with placebo when added to standard of care in adults with type 2 diabetes and established cardiovascular disease.
These data were presented at the American Diabetes Association ( ADA ) 76th Scientific Sessions in New Orleans,

Data presented at the ADA Scientific Sessions examined the effect of treatment with Empagliflozin by age in the EMPA-REG OUTCOME trial. Trial participants were grouped based on their age at baseline: under 65 years, from 65 to 74, and 75 years and older.
Consistent reduction in the risk of cardiovascular death was seen independent of age groups. Further analysis demonstrated similar consistency by age group in reducing risk for hospitalisation for heart failure, as well as for the combination of hospitalisation for heart failure or cardiovascular death.
Adverse events were consistent with the known safety profile of Empagliflozin.

Furthermore, the reduction in risk for cardiovascular events did not differ among sub-groups of people in the EMPA-REG OUTCOME trial based on their LDL cholesterol levels at baseline ( less than 70 mg/dL; 70- less than 85 mg/dL; 85- less than 100 mg/dL; 100-115 mg/dL; and more than 115 mg/dL ).
The risk reduction with Empagliflozin was consistent across the LDL sub-groups ( indicated by a lack of statistical interaction by sub-group ) for the combination of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke, as well as for the individual outcomes of cardiovascular death, hospitalisation for heart failure and death from any cause.

EMPA-REG OUTCOME was a long-term, multicentre, randomised, double-blind, placebo-controlled trial of more than 7,000 patients from 42 countries with type 2 diabetes and established cardiovascular disease.
The study assessed the effect of Empagliflozin ( 10 mg or 25 mg once daily ) added to standard of care compared with placebo added to standard of care.
Standard of care was comprised of glucose-lowering agents and cardiovascular drugs ( including for blood pressure and cholesterol ).
The primary endpoint was defined as time to first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke.

Over a median of 3.1 years, Empagliflozin significantly reduced the risk of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke by 14% versus placebo. Risk of cardiovascular death was reduced by 38%, with no significant difference in the risk of non-fatal myocardial infarction or non-fatal stroke.

Empagliflozin is an oral, once daily, highly selective sodium glucose co-transporter 2 ( SGLT2 ) inhibitor. Empagliflozin works by blocking the reabsorption of glucose by the kidney, leading to urinary glucose excretion, and lowering blood glucose levels in people with type 2 diabetes.
SGLT2 inhibition targets glucose directly and works independently of beta-cell function and the insulin pathway.

Empagliflozin is not for people with type 1 diabetes or for people with diabetic ketoacidosis ( increased ketones in the blood or urine ). ( Xagena )

Source: Boehringer Ingelheim, 2016

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