Indications and Usage of Dapagliflozin for Patients with Type 2 Diabetes
Dapagliflozin is indicated for improving glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise, with additional indications for cardiovascular and renal protection in specific patient populations. 1, 2
Primary Indications for Dapagliflozin in Type 2 Diabetes
- Approved for improving glycemic control in adults with type 2 diabetes as monotherapy or as add-on therapy to other antidiabetic medications, including metformin, sulfonylureas, DPP-4 inhibitors, and insulin 1, 3
- Indicated for pediatric patients aged 10 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise 3
- Recommended for patients with type 2 diabetes who have heart failure (with either reduced or preserved ejection fraction) to prevent hospitalization for heart failure 1, 2
- Indicated for patients with type 2 diabetes who have chronic kidney disease (eGFR 20-60 mL/min/1.73 m² and/or albuminuria) to minimize CKD progression and reduce cardiovascular events 1
- Recommended for patients with type 2 diabetes and established atherosclerotic cardiovascular disease (ASCVD) or multiple cardiovascular risk factors to reduce the risk of hospitalization for heart failure 1, 2
Dosing and Administration
- Standard dose is 10 mg once daily, taken orally in the morning 2, 3
- For pediatric patients aged 10-17 years, starting dose is 5 mg once daily, with potential up-titration to 10 mg if HbA1c remains ≥7% after 14 weeks 3
- No dose adjustment is required for patients with mild to moderate renal impairment (eGFR ≥30 mL/min/1.73 m²) 3
- Can be used in patients with eGFR as low as 20 mL/min/1.73 m², though glycemic efficacy is reduced when eGFR <45 mL/min/1.73 m² 1, 3
Clinical Benefits Beyond Glycemic Control
- Reduces risk of hospitalization for heart failure by approximately 27% in patients with type 2 diabetes and cardiovascular risk factors 2, 4
- Decreases risk of progression of kidney disease, including sustained decline in eGFR, end-stage kidney disease, or renal death 1, 4
- Provides modest weight reduction of approximately 2-3 kg 5, 6
- Produces mild reductions in blood pressure (systolic 2-5 mmHg, diastolic 1.5-3 mmHg) 5
- Demonstrates cardiovascular benefits independent of glycemic control, as shown in the DECLARE-TIMI 58 trial 1, 7
Glycemic Efficacy
- Produces HbA1c reductions of approximately 0.5-0.9% when used as monotherapy or add-on therapy 1, 6
- Works through an insulin-independent mechanism by inhibiting SGLT2 in the proximal tubule, preventing reabsorption of filtered glucose 8, 5
- Provides consistent glycemic efficacy across various patient populations, including those with inadequate control on metformin, insulin, or other oral antidiabetic agents 3, 6
- Demonstrates low risk of hypoglycemia when used as monotherapy due to its insulin-independent mechanism of action 5, 6
Safety Considerations and Contraindications
- Common adverse effects include genital mycotic infections and urinary tract infections 1, 5
- Risk of volume depletion, particularly in patients with renal impairment, elderly patients, or those on diuretics 1, 2
- Rare but serious risk of euglycemic diabetic ketoacidosis, especially in vulnerable patients 1
- Contraindicated in patients with history of serious hypersensitivity to dapagliflozin 1
- Not recommended during pregnancy or breastfeeding due to potential risks to the developing kidney 3
- Should be temporarily discontinued at least 3 days before scheduled surgery to prevent postoperative ketoacidosis 2
Place in Therapy According to Guidelines
- Recommended as part of glucose-lowering regimen for patients with type 2 diabetes and established ASCVD, heart failure, or CKD, independent of HbA1c levels and metformin use 1
- Can be considered early in the treatment algorithm for patients with type 2 diabetes who have or are at high risk for cardiovascular or renal complications 1
- May be used in combination with GLP-1 receptor agonists for complementary cardiovascular and renal benefits 1
- Should be included in treatment regimens irrespective of the need for additional glucose lowering in patients with established cardiovascular or kidney disease 1