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On August 27, 2021, Boehringer Ingelheim and Eli Lilly and Company jointly announced the Phase 3 clinical trial of their SGLT2 inhibitor empagliflozin (empagliflozin, English trade name Jardiance) EMPEROR-Preserved achieved positive results
.
The trial reached its composite primary endpoint, that is, in adult patients with preserved ejection fraction heart failure (HFpEF), empagliflozin reduced the relative risk of cardiovascular death or hospitalization for heart failure by 21% compared with placebo
Earlier this month, the US FDA approved the drug to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with reduced ejection fraction heart failure (HFrEF)
.
The press release pointed out that the benefit of the primary endpoint of this phase 3 clinical trial has nothing to do with the patient's ejection fraction or diabetes status.
Empagliflozin is a highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor that is taken orally once a day.
In patients with type 2 diabetes with high blood sugar levels, the inhibition of SGLT2 by empagliflozin can prevent glucose The kidneys reabsorb, allowing more sugar to be excreted in the urine
.
In addition, Enpagliflozin can prevent the reabsorption of salt, thereby increasing the excretion of salt in the body and reducing the fluid load of the body's vascular system
A total of 5988 patients were enrolled in the EMPEROR-Preserved trial
.
Among them, 4005 cases had left ventricular ejection fraction (LVEF) ≥50%, and 1983 cases had LVEF lower than 50%
▲The primary and critical secondary endpoint data of the EMPEROR-Preserved trial (picture source: reference [2])
Heart failure is divided into HFrEF and HFpEF
.
When the heart muscle cannot contract effectively, HFrEF occurs, and the heart pumps less blood into the body
The previous phase 3 clinical trial EMPEROR-Reduced, which enrolled a total of 3730 HFrEF patients (with or without type 2 diabetes), showed that compared with placebo, empagliflozin reduced patients’ cardiovascular death and heart failure.
Reference materials:
[1] Landmark trial demonstrates Jardiance® (empagliflozin) is the first therapy to show statistically significant improvement in heart failure outcomes in adults with preserved ejection fraction.
[2] Anker et al.
