What is the US equivalent of Vildagliptin (Galvus) 50 mg?

Equivalent of Vildagliptin 50 mg in the US

The US equivalent of Vildagliptin (Galvus) 50 mg is sitagliptin (Januvia) 100 mg, as both are DPP-4 inhibitors with similar efficacy profiles, though vildagliptin is not FDA-approved in the United States. 1, 2

DPP-4 Inhibitors Available in the US

• Sitagliptin 100 mg daily is the most appropriate US equivalent to vildagliptin 50 mg twice daily, as both medications belong to the same class (DPP-4 inhibitors) and have similar efficacy in glycemic control 1
• Other FDA-approved DPP-4 inhibitors in the US include:
  • Saxagliptin 5 mg daily 1
  • Linagliptin 5 mg daily 1
  • Alogliptin 25 mg daily 1

Comparison of Vildagliptin with US DPP-4 Inhibitors

• Vildagliptin 50 mg is typically dosed twice daily (total 100 mg/day) when used as monotherapy or with metformin, but once daily (50 mg) when combined with sulfonylureas 2, 3
• Sitagliptin is dosed at 100 mg once daily, making it the closest match to the total daily dose of vildagliptin 1
• All DPP-4 inhibitors work through the same mechanism: inhibiting DPP-4 activity to prolong the survival of endogenously released incretin hormones 1
• Clinical trials have shown similar efficacy among different DPP-4 inhibitors in reducing HbA1c levels 2, 3

Dosing Considerations for Special Populations

• For patients with renal impairment:
  • Sitagliptin requires dose adjustment: 50 mg daily if eGFR 30-50 mL/min/1.73 m² and 25 mg daily if eGFR <30 mL/min/1.73 m² 1
  • Linagliptin requires no dose adjustment in renal impairment, making it an alternative option for patients with kidney disease 1
• For elderly patients, DPP-4 inhibitors are generally well-tolerated with low risk of hypoglycemia 1, 2

Clinical Benefits and Safety Profile

• DPP-4 inhibitors offer several advantages:
  • Low risk of hypoglycemia compared to sulfonylureas 1, 2
  • Weight neutral effect 1, 2
  • Once-daily dosing for most US options (except vildagliptin which is twice daily) 1
• Common side effects include:
  • Occasional reports of urticaria/angioedema 1
  • Rare cases of pancreatitis have been observed 1, 2
  • Vildagliptin specifically has been associated with liver enzyme elevations at higher doses, requiring liver function monitoring 2

Cost Considerations

• According to 2021 data, the median monthly cost for maximum approved daily doses:
  • Sitagliptin 100 mg: $568 (AWP) and $456 (NADAC) 1
  • Saxagliptin 5 mg: $530 (AWP) and $424 (NADAC) 1
  • Linagliptin 5 mg: $555 (AWP) and $444 (NADAC) 1
  • Alogliptin 25 mg: $234 (AWP) and $175 (NADAC) 1
• By 2024, sitagliptin 100 mg costs had increased to $588 (AWP) and $550 (NADAC) 1

Important Clinical Caveat

• While vildagliptin is widely used internationally (marketed as Galvus), it has never received FDA approval in the United States despite showing similar efficacy to other DPP-4 inhibitors 2, 3
• A modified-release formulation of vildagliptin 100 mg for once-daily dosing has been developed but is also not available in the US 4