Empagliflozin Reference

Plain English

What it is

Empagliflozin, sold under the brand name Jardiance, is a prescription pill known as an SGLT2 inhibitor. It works by helping the kidneys pass extra blood sugar out of the body through urine. The FDA has approved it for type 2 diabetes, for certain heart failure, and for chronic kidney disease.

What people use it for

It is prescribed to lower blood sugar in adults and in children age 10 and older who have type 2 diabetes. It is also used to lower the chance of dying from heart causes in adults who have type 2 diabetes plus known heart disease, to help adults living with heart failure, and to slow kidney disease in adults at risk.

What the science shows

It is one of the most studied medicines in its class. In a large trial of people with type 2 diabetes and existing heart disease, it lowered deaths from heart causes and deaths from any cause compared with a placebo. Later large trials found benefits for heart failure and for chronic kidney disease.

The catch

It commonly causes genital yeast infections and urinary tract infections. It can also lower body fluid and blood pressure, which matters more for people already on water pills. A rare but serious risk is a dangerous buildup of acid in the blood (ketoacidosis) that can happen even when blood sugar looks normal, and it is not meant for type 1 diabetes.

Reference summary

EMPA-REG OUTCOME (Zinman 2015 NEJM, n=7,020 adults with T2D and established CVD) reported a 14 percent relative reduction in the primary 3-component MACE composite and a 38 percent relative reduction in cardiovascular death (plus a 32 percent reduction in all-cause mortality) over a median 3.1 years - the first SGLT2 trial to show a mortality benefit. EMPEROR-Reduced and EMPEROR-Preserved subsequently established heart-failure benefit across the ejection fraction spectrum; EMPA-KIDNEY established CKD benefit.

Regulatory and posture

Categories

Metabolic

Aliases

Jardiance, SGLT2 inhibitor (small molecule, not a peptide)

Evidence posture

human

Regulatory status

FDA-approved as Jardiance for type 2 diabetes (2014), reduction in cardiovascular death in adults with T2D and established cardiovascular disease (2016), heart failure with reduced ejection fraction (2021), heart failure with preserved ejection fraction (2022), and chronic kidney disease (2023). Fixed-dose combinations with metformin (Synjardy) and linagliptin (Glyxambi) are also approved.

Content review status

label verified