What is the indication for Jardiance (Empagliflozin)?

From the Guidelines

Jardiance (empagliflozin) should be initiated at a dose of 10 mg once daily to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with type 2 diabetes and established cardiovascular disease, as demonstrated by the EMPA-REG OUTCOME trial 1. The EMPA-REG OUTCOME trial, a randomized, double-blind study, showed that empagliflozin reduced the composite outcome of MI, stroke, and cardiovascular death by 14% and cardiovascular death by 38% in patients with type 2 diabetes and existing cardiovascular disease 1. As a sodium-glucose cotransporter-2 (SGLT2) inhibitor, Jardiance works by preventing glucose reabsorption in the kidneys, causing excess glucose to be eliminated through urine, which lowers blood sugar levels. Key considerations for Jardiance use include:

• Typical starting dose: 10 mg once daily, taken in the morning with or without food
• Indications: improve glycemic control in adults with type 2 diabetes, reduce risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease
• Contraindications: patients with type 1 diabetes, severe kidney disease, or end-stage renal disease
• Common side effects: urinary tract infections, genital yeast infections, increased urination
• Rare but serious side effects: diabetic ketoacidosis
• Monitoring: regular kidney function monitoring during treatment According to the 2020 expert consensus decision pathway on novel therapies for cardiovascular risk reduction in patients with type 2 diabetes, SGLT2 inhibitors with CV benefit, such as Jardiance, should be initiated at the lowest dose tested in CV and renal outcomes trials, which is 10 mg daily 1. No further dose titration is needed for CV or renal risk reduction, but dose increases may provide further glucose reduction benefits if indicated. Overall, Jardiance is a valuable treatment option for patients with type 2 diabetes and established cardiovascular disease, offering cardiovascular benefits beyond glycemic control.

From the FDA Drug Label

JARDIANCE is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated: as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease. Limitations of Use: Not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis

The main use of Jardiance (empagliflozin) is as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus and to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease 2.

• It is not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
• The recommended dose is 10 mg once daily, taken in the morning, with or without food, and may be increased to 25 mg once daily 2.

From the Research

Overview of Jarndiance (Empagliflozin)

• Empagliflozin, marketed as Jardiance, is a sodium glucose cotransporter-2 (SGLT2) inhibitor used in the treatment of type 2 diabetes mellitus (T2DM) 3, 4, 5, 6, 7.
• It works by inhibiting the reabsorption of glucose from the proximal tubules in the kidney, providing an insulin-independent mechanism of lowering blood glucose 7.

Efficacy and Benefits

• Empagliflozin has been shown to improve glycemic control, reduce body weight, and lower blood pressure in patients with T2DM 3, 5, 6, 7.
• It has demonstrated cardioprotective and renoprotective properties, reducing the risk of cardiovascular events and hospitalization for heart failure in patients with T2DM and established cardiovascular disease 3, 4, 6.
• The EMPA-REG OUTCOME study found that empagliflozin reduced the risk of major adverse cardiovascular events (MACE) by 14% and the risk of cardiovascular death by 38% compared to placebo 6.

Safety and Tolerability

• Empagliflozin is generally well tolerated, with common adverse events including genital mycotic infections, mild urinary tract infections, and a risk of hypotension and volume depletion 3, 4, 5, 6, 7.
• It has a low intrinsic risk of hypoglycaemia, although hypoglycaemia can occur when coadministered with insulin and/or a sulfonylurea 7.

Clinical Use

• Empagliflozin is indicated for the treatment of T2DM as monotherapy or as add-on therapy to other antihyperglycaemic agents, including insulin 3, 7.
• It is available in doses of 10 mg and 25 mg once daily and is reimbursed in some countries as an add-on to background glucose-lowering therapy 5.