What is the recommended use and dosage of Jardiance (empagliflozin) for patients with type 2 diabetes?

Recommended Use and Dosage of Jardiance (Empagliflozin) for Type 2 Diabetes

Jardiance (empagliflozin) is recommended at a starting dose of 10 mg once daily in the morning, taken with or without food, for patients with type 2 diabetes as an adjunct to diet and exercise. 1

Dosing and Administration

• The recommended initial dose is 10 mg once daily, taken in the morning with or without food 1
• In patients tolerating the initial dose, it may be increased to 25 mg once daily for additional glycemic control benefits 1
• No dose titration is needed for cardiovascular or renal risk reduction benefits, as there is no evidence of a graded dose response for these outcomes 2

Indications

• Primary indication: Improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise 1, 2
• Secondary indication: Reduce risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease 1, 2
• Empagliflozin has demonstrated a 38% relative risk reduction in cardiovascular death in patients with established cardiovascular disease 2, 3

Renal Considerations

• Assessment of renal function is recommended prior to initiation and periodically thereafter 1
• Do not initiate in patients with eGFR less than 45 mL/min/1.73 m² 1
• No dose adjustment needed in patients with eGFR greater than or equal to 45 mL/min/1.73 m² 1
• Discontinue if eGFR falls persistently below 45 mL/min/1.73 m² 1

Contraindications

• History of serious hypersensitivity reaction to empagliflozin or any excipients 1
• Severe renal impairment, end-stage renal disease, or dialysis 1

Precautions and Monitoring

• Assess and correct volume status before initiating, particularly in patients with renal impairment, elderly patients, those with low systolic blood pressure, or patients on diuretics 1, 2
• Monitor for signs and symptoms of hypotension after initiating therapy 1
• Discontinue at least 3 days before planned surgery to prevent postoperative ketoacidosis 2
• If HbA1c is well-controlled at baseline or there's a history of frequent hypoglycemic events, consider reducing doses of insulin or insulin secretagogues when starting empagliflozin 2
• May contribute to intravascular volume contraction; consider stopping or reducing diuretic dose if applicable 2

Adverse Effects to Monitor

• Genital fungal infections 2, 4
• Urinary tract infections 2, 4
• Euglycemic diabetic ketoacidosis 2, 1
• Volume depletion and hypotension, especially in elderly patients 1
• Potential hepatotoxicity 5

Cardiovascular Benefits

• In the EMPA-REG OUTCOME trial, empagliflozin reduced:
  • Cardiovascular death by 38% (absolute rate 3.7% vs 5.9% in placebo) 2, 3
  • Hospitalization for heart failure by 35% 2, 3
  • All-cause mortality by 32% (absolute rate 5.7% vs 8.3% in placebo) 3
• These benefits were consistent across the spectrum of heart failure risk, including patients at low-to-average, high, and very high risk for heart failure 6
• Cardiovascular benefits appear to be independent of glycemic control and may be related to effects on gut microbiota and plasma metabolites 7

Special Considerations

• The cardiovascular benefits of empagliflozin make it a valuable option for patients with type 2 diabetes and established cardiovascular disease 4, 2
• Unlike canagliflozin (another SGLT2 inhibitor), empagliflozin has not been associated with an increased risk of amputation or bone fractures 4
• Empagliflozin's diuretic effect may contribute to its benefits in preventing heart failure 5, 6