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On November 18, Grigg Ingham 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), with Jardiance or placebo combined standard care.
, 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 occurs for the first time.
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.
results, 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 during the three-year period of joint standard care treatment (3.2 years of middle follow-up in the Jardiance group and 3.1 years in the placebo group), Jardiance reduced the risk of the following overall (first-time recurrence) events compared to placebo: 3P-MACE decreased by 22% (RR-0.) 78 (95% CI: 0.67-0.91) ;p =0.0020); 42% reduction in hospitalization for heart failure (RR=0.58) (95% CI: 0.42-0.81) ;p (0.0012); 17% reduction in all-cause hospitalization (RR=0.83 (95% CI:0.76-0.91) ;p<0.0001); 21% reduction in fatal or non-fatal myocardial infarction (heart attack) (RR) RR=0.79 (95%CI:0.62-0.998) ;p=0.049); coronary heart disease events (myocardial infarction and coronary artery blood transport reconstruction) decreased by 20% (RR=0.80?95). %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 overall 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 Grigg Ingeham and Lilly Diabetes Alliance is continuing to explore Jardiance's potential to improve the health of patients with T2D and cardiovascular disease.
EMPOWER 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 diabetes 2.Effects of empagliflozin on first and recurrent event clinicals in patients with type 2 diabetes and atherosclerotic cardiovascular disease: a secondary analysis of the EMPA-REG TRIAL