Dapagliflozin: Not a New Drug for Type 2 Diabetes Management
Dapagliflozin is not a new drug for type 2 diabetes management, as it has been available for several years and has established efficacy and safety data from numerous clinical trials dating back to at least 2011. 1, 2, 3
History and Development
- Dapagliflozin was the first sodium-glucose co-transporter-2 (SGLT2) inhibitor approved by the European Medicines Agency (EMA) for the treatment of type 2 diabetes 2
- It was developed as an oral antihyperglycemic agent and has been studied in clinical trials since at least 2010-2011 3, 4
- By 2014, dapagliflozin was already well-established with numerous completed clinical trials demonstrating its efficacy and safety profile 1, 4
Current FDA Indications
Dapagliflozin is currently FDA-approved for multiple indications:
- To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression 5
- To reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure 5
- To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus with established cardiovascular disease or multiple cardiovascular risk factors 5
- As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus 5
Established Clinical Evidence
Multiple large cardiovascular outcomes trials (CVOTs) have been completed with dapagliflozin, including:
By 2021, dapagliflozin had already accumulated substantial evidence supporting its use in:
Mechanism of Action
- Dapagliflozin works by inhibiting SGLT2 in the kidneys, increasing urinary glucose excretion and reducing hyperglycemia 7, 1
- This mechanism of action is independent of insulin secretion or action, making it complementary to other antihyperglycemic medications 1, 2
Clinical Use and Positioning
- Dapagliflozin is well-established in clinical practice guidelines for type 2 diabetes management 6, 7
- It is commonly used in combination with other antidiabetic medications such as metformin, sitagliptin, and insulin 7, 5
- The standard dosing for glycemic control starts at 5 mg once daily, with potential to increase to 10 mg once daily 5
- For cardiovascular and renal indications, the recommended dose is 10 mg once daily 5
Safety Profile
- Dapagliflozin has a well-characterized safety profile based on years of clinical use 1, 4
- Common side effects include increased risk of genital mycotic infections and urinary tract infections 6, 5
- It has a low risk of hypoglycemia when used as monotherapy 1, 2
- Cautions include use in patients with renal impairment (not recommended for glycemic control if eGFR <45 mL/min/1.73m²) 7, 5
In conclusion, dapagliflozin has been available for clinical use for over a decade, with extensive research and clinical experience supporting its efficacy and safety. It is not a new drug but rather an established treatment option for type 2 diabetes with additional proven benefits for cardiovascular and renal outcomes.