New data showed Empagliflozin ( Jardiance ) reduces the risk for new-onset or worsening kidney disease by 39% versus placebo when added to standard of care in people with type 2 diabetes with established cardiovascular disease.
The findings have been published in The New England Journal of Medicine ( NEJM ) and also presented at the American Diabetes Association ( ADA ) 76th Scientific Sessions in New Orleans.
These findings were part of a pre-specified exploratory analysis plan of additional endpoints of the landmark EMPA-REG OUTCOME trial. New-onset or worsening kidney disease was a pre-specified composite endpoint that included the below clinical events.
Compared with placebo, Empagliflozin led to the following statistically significant changes in outcomes: 55% reduction in the initiation of kidney replacement therapy ( such as dialysis ); 44% reduction in doubling of creatinine ( a waste product usually filtered by the kidneys ) in the blood; 38% reduction in progression to macroalbuminuria ( very high levels of a protein called albumin in the urine ).
Empagliflozin also significantly slowed the decline in kidney function over time compared with placebo.
Most patients in this trial were already taking the recommended standard treatment for kidney disease in type 2 diabetes, renin angiotensin aldosterone system blockade; the kidney effects of Empagliflozin were apparent on top of these agents.
Consistent risk reductions in kidney outcomes with Empagliflozin were seen in people who had impaired kidney function, or increased levels of albumin in the urine, at baseline and in those who did not, according to a post hoc sub-group analysis.
Serious adverse events and adverse effects leading to treatment discontinuation for Empagliflozin versus placebo were comparable for those with or without impaired kidney function at baseline.
Death due to kidney disease was rare and occurred in three patients treated with Empagliflozin ( 0.1% ) and none treated with placebo.
Empagliflozin is the only SGLT2 inhibitor associated with evidence of slowing the progression of kidney disease in adults with type 2 diabetes and established cardiovascular disease in a cardiovascular outcome study.
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.
The overall safety profile of Empagliflozin in the EMPA-REG OUTCOME trial was consistent with that of previous trials.
Empagliflozin is an oral, once daily, highly selective sodium glucose co-transporter 2 ( SGLT2 ) inhibitor approved for the treatment of adults with type 2 diabetes.
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