What is the recommended treatment and dosage for type 2 diabetes mellitus using Vildagliptine (Galvus)?

Vildagliptin (Galvus) Treatment for Type 2 Diabetes Mellitus

Vildagliptin 50 mg twice daily is the recommended dosage for most patients with type 2 diabetes, typically used in combination with metformin for optimal glycemic control. 1, 2

Mechanism and Clinical Efficacy

• Vildagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that increases endogenous GLP-1 levels by 2-3 fold and GIP levels by approximately 5-fold, enhancing insulin secretion and suppressing glucagon in a glucose-dependent manner 3
• The VERIFY trial demonstrated that initial combination therapy with metformin and vildagliptin is superior to sequential addition of medications for extending primary and secondary failure of glycemic control 1
• Vildagliptin significantly reduces both fasting and postprandial glucose levels with no substantial additional benefits at doses greater than 50 mg twice daily 3

Dosage Recommendations

• Standard dosage: 50 mg twice daily when used in combination with metformin or a thiazolidinedione 2
• Reduced dosage: 50 mg once daily when used in combination with a sulfonylurea 2
• Fixed-dose combination of vildagliptin/metformin (Eucreas) is available to improve medication adherence 4

Special Populations and Renal Considerations

• No dosage adjustment is required for elderly patients, although exposure increases by approximately 30% (primarily due to decreased renal function) 3
• In patients with renal impairment:
  • Vildagliptin exposure increases approximately 2-fold in renal impairment 3
  • The drug has been studied and shown to be effective and well-tolerated at 50 mg once daily in patients with severe renal impairment (eGFR <30 mL/min/1.73 m²) 5
  • Unlike some other DPP-4 inhibitors, vildagliptin does not require dose adjustment based on the severity of renal impairment 3

Advantages and Safety Profile

• Vildagliptin has a low risk of hypoglycemia compared to sulfonylureas, particularly when used as monotherapy or in combination with metformin 3, 2
• The medication is weight neutral, providing an advantage over insulin or sulfonylureas 2
• Gastrointestinal side effects are less common with vildagliptin (9.6%) compared to placebo (18.2%) when added to metformin 6
• Vildagliptin has a favorable cardiovascular safety profile 2

Common Side Effects and Monitoring

• Principal side effects include gastrointestinal intolerance, which can be mitigated by gradual dose titration 1
• Liver function should be monitored in patients receiving vildagliptin, as transaminase elevations have been observed, particularly at higher doses (100 mg once daily) 2
• Meta-analyses suggest that vildagliptin 50 mg once or twice daily is not associated with increased risk of hepatic adverse events, pancreatitis, cardiovascular events, or skin-related toxicity 2

Treatment Algorithm

1. First-line therapy: Metformin remains the first-line agent for most patients with type 2 diabetes 1
2. Second-line therapy: Add vildagliptin 50 mg twice daily if glycemic targets are not achieved with metformin alone 1, 2
3. Alternative combinations:
   • With sulfonylureas: Vildagliptin 50 mg once daily 2
   • With thiazolidinediones: Vildagliptin 50 mg twice daily 2

Clinical Pearls and Caveats

• Vildagliptin does not affect gastric emptying, contributing to its favorable gastrointestinal safety profile 3
• The medication can be taken without regard to food 3
• For patients with established cardiovascular disease or high cardiovascular risk, GLP-1 receptor agonists or SGLT2 inhibitors with proven cardiovascular benefits may be preferred over DPP-4 inhibitors 1
• In patients with diabetic kidney disease, SGLT2 inhibitors are generally preferred first, with GLP-1 RAs as alternatives when SGLT2 inhibitors are not tolerated 1