Engli Net Milestone Phase 3 Clinical: Treatment of Type 2 Diabetes significantly reduces the risk of cardiovascular events

Compiled on November 18, GriggIngham and Lilly Diabetes Alliance announced the results of a new post-mortem analysis of the SGLT2 inhibitor Jardiance (empagliflozin, Ingley Net) milestone EMPA-REG OUTCOME trial.
the study was conducted in adult patients with type 2 diabetes (T2D) and atherosclerotic cardiovascular disease (ASCVD), jardiance or placebo combined standard care was treated.
, Jardiance reduced the overall risk of cardiovascular events (first plus recurrence) compared to placebo over a three-year period, according to the study.
overall cardiovascular events include: 3P-MACE (non-fatal heart attack, non-fatal stroke, cardiovascular death), hospitalization for heart failure, all-cause hospitalization.
EMPA-REG OUTCOME is a long-term, multi-center, randomized, double-blind, placebo-controlled trial of 7,020 adult patients (age ≥18) with T2D and ASCVD from 42 countries.
study assessed the effectiveness of adding Jardiance (10 mg or 25 mg once a day) or placebo to the standard of care.
standards include sugar-lowering and cardiovascular drugs ( including those for hypertension and hypercholesterolemia).
end point is defined as the time when 3P-MACE first occurs.
previously released data showing that Jardiance reduced the risk of 3P-MACE by 14 per cent compared to placebo in combined standard care, driven by a 38 per cent reduction in the relative risk of cardiovascular death.
based on this result, Jardiance was approved by the FDA in December 2016 to reduce the risk of cardiovascular death in adult patients with T2D with complications of cardiovascular disease.
the approval makes Jardiance the world's first sugar-lowering drug to reduce the risk of cardiovascular death in patients with T2D.
New exploratory analysis showed that jardiance reduced the risk of the following overall (first-recurrence) events by 3P-MACE (RR-0.1 years) compared to placebo over a three-year period of combined standard care treatment (3.2 years in the Jardiance group and 3.1 years in the placebo group). 78 (95% CI: 0.67-0.91) ;p .002 ;p 0); 0.0012); 17% reduction in all-cause hospitalizations (RR=0.83 (95% CI:0.76-0.91) ;p<0.0001); 21% reduction in fatal or non-fatal myocardial infarction (heart attack) (RR) 0.79 (95% CI: 0.62-0.998) ;p .049); coronary heart disease events (myocardial infarction and coronary artery blood transport reconstruction) decreased by 20% (RR=0.80? %CI:0.67-0.95],p=0.012）。
there was no significant difference between treatment groups for overall fatal and non-fatal stroke (RR=1.10 (95% CI: 0.82-1.49) ;p=0.52).
study, Jardiance's overall safety was consistent with what had been observed in previous clinical trials.
cardiovascular events in patients with T2D led to considerable clinical and socio-economic burdens.
assessment of first and relapse events can be used to estimate the total burden of cardiovascular events.
new exploratory analysis confirms that Jardiance reduces the overall burden of cardiovascular complications and all-cause hospitalization in adult patients with T2D and ASCVD.
new exploratory analysis data have been published in The Lancet Diabetes and Endocrinology.
these new results support the early and ongoing cardiovascular benefits of Jardiance in the three-year EMPA-REG OUTCOME trial.
T2D and cardiovascular disease are complex and lifelong, and it is critical for patients to reduce the risk of major heart-related consequences after the first event.
, the Blinger Ingeham and Lilly Diabetes Alliance are continuing to explore Jardiance's potential to improve the health of patients with T2D and cardiovascular disease.
THEEMPOWER program is one of the largest cardiovascular clinical programs to date for SGLT2 inhibitors, with nine clinical uses involving 377,000 patients worldwide.
source: 1. Lilly's Jardiance reduced risk of cardiovascular events in adults with type 2 diabetes2. Effects of empagliflozin on first and recurrent clinical events in patients with type 2 diabetes and atherosclerotic cardiovascular disease: a secondary analysis of the EMPA-REG OUTCOME trial