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

Glyxambi (Empagliflozin/Linagliptin) for Type 2 Diabetes: Recommended Use and Dosage

Glyxambi (empagliflozin/linagliptin) is recommended as a once-daily fixed-dose combination tablet at either 10mg/5mg or 25mg/5mg for adults with type 2 diabetes as an adjunct to diet and exercise when both medications are appropriate treatments. 1

Mechanism of Action and Benefits

• Glyxambi combines two complementary mechanisms of action: empagliflozin (SGLT2 inhibitor) removes glucose through the urine by blocking renal glucose reabsorption, while linagliptin (DPP-4 inhibitor) increases incretin hormones that stimulate insulin production and decrease glucagon levels 1, 2
• This combination provides improved glycemic control with the additional benefits of modest weight loss and blood pressure reduction 1, 3
• Both empagliflozin and linagliptin have demonstrated cardiovascular benefits in patients with type 2 diabetes, with empagliflozin specifically reducing the risk of cardiovascular death 4

Dosing Recommendations

• Glyxambi is available in two fixed-dose combinations: empagliflozin 10mg/linagliptin 5mg or empagliflozin 25mg/linagliptin 5mg 1
• The recommended starting dose is empagliflozin 10mg/linagliptin 5mg taken once daily 5
• No dose titration is required for cardiovascular or renal risk reduction benefits with the empagliflozin component 5
• If additional glycemic control is needed, the dose may be increased to empagliflozin 25mg/linagliptin 5mg once daily 5
• Glyxambi can be taken at any time of day, with or without food 5

Renal Considerations

• For patients with eGFR ≥45 mL/min/1.73 m², no dose adjustment is required 5
• For patients with eGFR <45 mL/min/1.73 m², empagliflozin is not recommended for glycemic control, though it may still be used for cardiovascular or renal benefits 5
• Empagliflozin is contraindicated in patients with severe renal impairment (eGFR <30 mL/min/1.73 m²) or those on dialysis 4, 5
• No dosage adjustments are required for the linagliptin component based on renal function 2

Clinical Efficacy

• Studies have shown that empagliflozin/linagliptin combination improves glycemic control significantly more than either component alone, particularly in patients with HbA1c <8.5% 6
• When used as add-on therapy to metformin, empagliflozin/linagliptin demonstrated significant reductions in HbA1c compared to placebo, with adjusted mean differences of -0.79% for the 10mg/5mg dose and -0.70% for the 25mg/5mg dose 7
• Empagliflozin has been shown to significantly reduce albuminuria compared to linagliptin, regardless of baseline albuminuria, eGFR, or HbA1c 8

Special Considerations and Precautions

• When initiating Glyxambi, consider reducing or stopping sulfonylureas/glinides or reducing total daily insulin dose by approximately 20% to prevent hypoglycemia 5
• Discontinue empagliflozin component at least 3 days before planned surgery to prevent postoperative ketoacidosis 5
• Monitor for genital mycotic infections and urinary tract infections, which occur more frequently with SGLT2 inhibitors 4, 5
• Use with caution in elderly patients (≥75 years) due to increased risk of volume depletion-related adverse reactions and urinary tract infections 9
• Glyxambi is not recommended for routine use in hospitalized patients 4

Common Pitfalls to Avoid

• Not adjusting concomitant diabetes medications (especially insulin or sulfonylureas) when starting Glyxambi increases hypoglycemia risk 5
• Forgetting to discontinue the empagliflozin component before surgical procedures increases ketoacidosis risk 5
• Using Glyxambi in patients with severe renal impairment (eGFR <30 mL/min/1.73 m²) or on dialysis is contraindicated 4
• Overlooking the need for monitoring of genital mycotic infections and urinary tract infections, which are more common with SGLT2 inhibitors 4

Patient Selection Considerations

• Glyxambi is particularly beneficial for patients with type 2 diabetes who also have established cardiovascular disease or are at high risk for cardiovascular events 4
• The combination is most effective in patients with HbA1c <8.5%; above this level, the combination may have less than additive effects compared to each agent alone 6
• Patients with diabetic kidney disease may benefit from the renoprotective effects of empagliflozin 4, 8