Usage
- Dapagliflozin + Vildagliptin is prescribed for the treatment of type 2 diabetes mellitus in adults when diet and exercise alone do not provide adequate glycemic control.
- Pharmacological Classification: Antidiabetic combination drug comprising a sodium-glucose cotransporter-2 (SGLT2) inhibitor (Dapagliflozin) and a dipeptidyl peptidase-4 (DPP-4) inhibitor (Vildagliptin).
- Mechanism of Action: Dapagliflozin increases urinary glucose excretion by inhibiting SGLT2 in the kidneys. Vildagliptin increases the levels of incretin hormones, which stimulate insulin release and decrease glucagon secretion, thereby improving glycemic control.
Alternate Names
- No widely recognized alternate names exist for the combination.
- Brand Names: This combination is available under various brand names, which can differ regionally. Some examples of brand names found are Vildapin DP, Vilingtin DZ, Dapatees V SR.
How It Works
- Pharmacodynamics: Dapagliflozin reduces renal glucose reabsorption, leading to increased urinary glucose excretion and lowered blood glucose levels. Vildagliptin enhances incretin hormone action, which increases glucose-dependent insulin secretion and reduces glucagon secretion, primarily in the postprandial state.
- Pharmacokinetics: Both drugs are orally administered. Dapagliflozin is primarily eliminated via renal excretion, while Vildagliptin is eliminated through both hepatic metabolism and renal excretion.
- Mode of Action: Dapagliflozin acts by directly inhibiting SGLT2 in the renal proximal tubules, blocking glucose reabsorption. Vildagliptin inhibits DPP-4, the enzyme responsible for degrading incretin hormones. This leads to increased levels of active GLP-1 and GIP.
- Receptor Binding/Enzyme Inhibition: Dapagliflozin targets SGLT2 receptors. Vildagliptin inhibits the DPP-4 enzyme.
- Elimination Pathways: Dapagliflozin is primarily excreted renally. Vildagliptin is both metabolized hepatically and excreted renally.
Dosage
Standard Dosage
Adults:
- The starting dose is typically Dapagliflozin 5 mg + Vildagliptin 50 mg once daily, taken orally in the morning.
- The dose may be increased to Dapagliflozin 10 mg + Vildagliptin 50 mg or Dapagliflozin 10 mg + Vildagliptin 100 mg (sustained-release formulation) once daily, depending on glycemic control and patient tolerance.
Children:
- The safety and efficacy of Dapagliflozin + Vildagliptin have not been established in pediatric patients. Use is not recommended.
Special Cases:
- Elderly Patients: Dose adjustment may be needed based on renal function.
- Patients with Renal Impairment: Dose reduction or avoidance may be necessary depending on the degree of impairment. For eGFR <45 ml/min/1.73 m², the combination is generally not recommended for glycemic control, although Dapagliflozin may be continued for cardiorenal benefits.
- Patients with Hepatic Dysfunction: Caution should be exercised. A starting dose of Dapagliflozin 5 mg is recommended in severe hepatic impairment.
- Patients with Comorbid Conditions: Careful assessment and dose adjustment may be required in patients with cardiovascular disease, heart failure, or other comorbidities.
Clinical Use Cases
Dapagliflozin + Vildagliptin is not indicated for:
- Intubation
- Surgical Procedures
- Mechanical Ventilation
- Intensive Care Unit (ICU) Use
- Emergency Situations
Dosage Adjustments
Dose adjustments are based on renal function, hepatic function, and individual patient response to therapy.
Side Effects
Common Side Effects:
- Urinary tract infections
- Nasopharyngitis
- Headache
- Dizziness
- Increased urination
- Thirst
- Genital infections
Rare but Serious Side Effects:
- Hypoglycemia (especially with concomitant insulin or sulfonylureas)
- Dehydration
- Kidney damage
- Diabetic ketoacidosis (in patients with type 1 diabetes)
- Angioedema
- Necrotizing fasciitis of the perineum (Fournier’s gangrene)
Long-Term Effects:
- Chronic kidney disease progression
- Cardiovascular complications
Adverse Drug Reactions (ADR):
Any of the rare but serious side effects mentioned above.
Contraindications
- Hypersensitivity to Dapagliflozin or Vildagliptin
- Type 1 diabetes mellitus
- Diabetic ketoacidosis
- Severe renal impairment (eGFR <30 ml/min/1.73m²)
- End-stage renal disease (ESRD) requiring dialysis
- Severe hepatic impairment
Drug Interactions
- Insulin and insulin secretagogues (sulfonylureas): Increased risk of hypoglycemia.
- Diuretics: Increased risk of dehydration and hypotension.
- Alcohol: Increased risk of hypoglycemia.
Pregnancy and Breastfeeding
- Pregnancy Safety Category: Dapagliflozin is generally not recommended during the second and third trimesters. Vildagliptin is contraindicated in pregnancy.
- Breastfeeding: It is not known if these drugs pass into breast milk. Use is generally not recommended.
Drug Profile Summary
- Mechanism of Action: Dapagliflozin: SGLT2 inhibition; Vildagliptin: DPP-4 inhibition.
- Side Effects: UTIs, nasopharyngitis, headache, dizziness, increased urination, hypoglycemia, dehydration.
- Contraindications: Type 1 diabetes, DKA, severe renal/hepatic impairment.
- Drug Interactions: Insulin, sulfonylureas, diuretics, alcohol.
- Pregnancy & Breastfeeding: Not recommended.
- Dosage: See above.
- Monitoring Parameters: HbA1c, fasting and postprandial glucose, renal function, blood pressure, electrolytes.
Popular Combinations
- Dapagliflozin + Vildagliptin is sometimes used in combination with Metformin.
Precautions
- Monitor for hypoglycemia, dehydration, and renal function.
- Caution in patients with renal or hepatic impairment.
- Avoid alcohol.
- Educate patients on signs and symptoms of hypoglycemia.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Dapagliflozin + Vildagliptin?
A: See dosage section above.
Q2: What are the common side effects?
A: Common side effects include urinary tract infections, nasopharyngitis, headache, dizziness, and increased urination.
Q3: Can this combination be used in patients with type 1 diabetes?
A: No, it is contraindicated in type 1 diabetes.
Q4: What are the serious side effects to watch for?
A: Hypoglycemia, dehydration, kidney damage, and necrotizing fasciitis of the perineum (Fournier’s Gangrene).
Q5: What drug interactions should I be aware of?
A: Interactions can occur with insulin, sulfonylureas, diuretics, and alcohol.
Q6: Can this drug be used during pregnancy or breastfeeding?
A: It is generally not recommended during pregnancy or breastfeeding.
Q7: How does Dapagliflozin + Vildagliptin work?
A: Dapagliflozin works by increasing urinary glucose excretion, while Vildagliptin enhances incretin hormone action to improve glucose-dependent insulin secretion.
Q8: What should patients be monitored for while taking this medication?
A: Patients should be monitored for HbA1c, glucose levels, renal function, blood pressure, and electrolytes.
Q9: What lifestyle modifications are recommended along with this medication?
A: Patients should be advised to follow a healthy diet, engage in regular physical activity, and maintain a healthy weight.
Q10: How should this medication be stored?
A: Store at room temperature, away from moisture, heat, and direct sunlight.
Please remember that this information is intended for qualified Indian doctors and healthcare professionals. It should not be used as a substitute for professional medical advice. Always consult the latest prescribing information and clinical guidelines.
