From the Guidelines
Forxiga (dapagliflozin) is a highly effective medication for treating type 2 diabetes, offering significant benefits in glucose control, weight loss, blood pressure reduction, and cardiovascular and renal protection, as evidenced by the DAPA-CKD trial 1.
Key Benefits of Forxiga
- Typically lowers HbA1c by 0.5-0.9% when used as monotherapy
- Offers modest weight loss (typically 2-3kg) and blood pressure reduction (by approximately 3-5 mmHg)
- Provides cardiovascular and renal protection, with a reduced risk of composite outcomes such as end-stage kidney disease, doubling of serum creatinine, or death from renal or cardiovascular causes
Dosage and Administration
- Standard dose is 10mg taken once daily in the morning, with or without food
- Patients should maintain adequate hydration while taking this medication
Important Considerations
- May not be suitable for those with severe kidney impairment (eGFR below 45 ml/min/1.73m²)
- Common side effects include genital yeast infections and increased urination
- Often prescribed alongside other diabetes medications like metformin when a single medication isn't providing adequate control
- Particularly beneficial for patients with coexisting cardiovascular disease or heart failure, as recommended by the 2019 ESC guidelines 1
Recent Evidence
- The DAPA-CKD trial demonstrated a significant reduction in the risk of the primary composite outcome with dapagliflozin therapy compared to placebo (HR 0.61 [95% CI 0.51–0.72]) 1
- The DECLARE-TIMI 58 trial also showed that dapagliflozin reduced the risk of cardiovascular events and renal outcomes in patients with type 2 diabetes and established ASCVD or multiple risk factors for ASCVD 1
From the FDA Drug Label
Dapagliflozin has been studied in adult patients as monotherapy, in combination with metformin, pioglitazone, sulfonylurea (glimepiride), sitagliptin (with or without metformin), metformin plus a sulfonylurea, or insulin (with or without other oral antidiabetic therapy), compared to a sulfonylurea (glipizide), and in combination with a GLP-1 receptor agonist (exenatide extended release) added on to metformin. Treatment with dapagliflozin as monotherapy and in combination with metformin, glimepiride, pioglitazone, sitagliptin, or insulin produced statistically significant improvements in mean change from baseline at Week 24 in HbA1c compared to control. At Week 24, treatment with dapagliflozin 10 mg QAM provided significant improvements in HbA1c and the fasting plasma glucose (FPG) compared with placebo.
Efficacy of Forxiga (Dapagliflozin) in Type 2 Diabetes Treatment:
- Dapagliflozin has shown statistically significant improvements in HbA1c and FPG levels compared to placebo in monotherapy and combination therapy trials.
- The medication has also demonstrated significant reductions in body weight compared to metformin XR alone.
- Key findings:
- HbA1c reduction: -0.9% (dapagliflozin 10 mg) vs -0.2% (placebo)
- FPG reduction: -28.8 mg/dL (dapagliflozin 10 mg) vs -4.1 mg/dL (placebo)
- Percentage of patients achieving HbA1c <7%: 50.8% (dapagliflozin 10 mg) vs 31.6% (placebo) 2
From the Research
Efficacy of Forxiga in Type 2 Diabetes Treatment
- Forxiga (dapagliflozin) has been shown to be effective in reducing blood glucose levels and body weight in patients with type 2 diabetes 3, 4, 5.
- Studies have demonstrated that dapagliflozin reduces the rate of cardiovascular death or hospitalization for heart failure and possibly reduces the progression of renal disease 3.
- Dapagliflozin has been found to be generally well tolerated, with a low risk of hypoglycaemia, although genital infections and urinary tract infections are more common with dapagliflozin than placebo 4, 5.
Mechanism of Action
- Dapagliflozin works by inhibiting the sodium-glucose cotransporter-2 (SGLT2) in the kidneys, reducing renal glucose reabsorption and increasing urinary glucose excretion 4, 5, 6.
- Its mechanism of action is independent of insulin secretion or action, making it a complementary therapy when used in combination with other antihyperglycaemic drugs 4, 5.
Clinical Studies
- Numerous well-designed clinical trials have consistently demonstrated the efficacy and tolerability of dapagliflozin in patients with type 2 diabetes 3, 4, 5.
- Extensions of these trials have shown that the effects of dapagliflozin are maintained over longer-term follow-up periods of up to 4 years 5.
- Dapagliflozin has been found to be effective as monotherapy and as add-on therapy to other glucose-lowering agents, including insulin 3, 4, 5.