What is the recommended use and dosage of Dapagliflozin (Forxiga) for patients with type 2 diabetes mellitus (T2DM) and heart failure?

From the Guidelines

Dapagliflozin (Forxiga) is recommended at a dose of 10 mg once daily for patients with both type 2 diabetes mellitus (T2DM) and heart failure, as it provides cardiovascular benefits independent of its glucose-lowering effects, as shown in the DAPA-HF trial 1. This medication can be taken with or without food at any time of day, though maintaining a consistent schedule is beneficial. For patients with heart failure with reduced ejection fraction (HFrEF), the 10 mg daily dose is recommended regardless of glycemic status. Patients should maintain adequate hydration while taking dapagliflozin and be monitored for potential side effects such as genital mycotic infections, urinary tract infections, and volume depletion. Dose adjustment is necessary for patients with severe renal impairment (eGFR <45 mL/min/1.73m²), and the medication is not recommended for those with end-stage renal disease, as indicated in the package inserts and guidelines 1. Dapagliflozin works by inhibiting sodium-glucose cotransporter-2 (SGLT2) in the kidneys, which increases urinary glucose excretion, reduces blood glucose levels, and provides cardioprotective effects through multiple mechanisms including improved cardiac energetics, reduced cardiac preload and afterload, and anti-inflammatory effects. Some key points to consider when prescribing dapagliflozin include:

• Monitoring for signs of volume depletion, such as orthostatic hypotension and dizziness
• Regular assessment of renal function, particularly in patients with pre-existing kidney disease
• Counseling patients on the importance of maintaining adequate hydration and recognizing the signs of potential side effects
• Considering the potential benefits of dapagliflozin in patients with T2DM and heart failure, as demonstrated in the EMPEROR-Reduced and DELIVER trials 1. Overall, dapagliflozin is a valuable treatment option for patients with T2DM and heart failure, offering benefits beyond glucose control, including reduced risk of hospitalization for heart failure and cardiovascular death, as supported by the evidence from the DAPA-HF and EMPEROR-Reduced trials 1.

From the FDA Drug Label

Dapagliflozin when used as a component of Dapagliflozin and Metformin HCl extended-release tablets is indicated in adults with type 2 diabetes mellitus to reduce the risk of: • Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression (1) • Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure. (1) • Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors (1)

• To improve glycemic control, for patients aged 10 years and older not already taking dapagliflozin, the recommended starting dosage for dapagliflozin is 5 mg once daily. (2.3) • For indications in adults related to heart failure and chronic kidney disease the recommended dosage of dapagliflozin is 10 mg once daily. (2. 3)

The recommended use of Dapagliflozin (Forxiga) for patients with type 2 diabetes mellitus (T2DM) and heart failure is as an adjunct to diet and exercise to improve glycemic control and reduce the risk of:

• Hospitalization for heart failure
• Cardiovascular death
• Urgent heart failure visit The recommended dosage of Dapagliflozin for these patients is 10 mg once daily 2.

From the Research

Recommended Use and Dosage of Dapagliflozin

The recommended use and dosage of Dapagliflozin (Forxiga) for patients with type 2 diabetes mellitus (T2DM) and heart failure are as follows:

• Dapagliflozin is indicated for the treatment of T2D as monotherapy or as add-on combination therapy with other glucose-lowering agents, including insulin, when diet and exercise alone do not provide adequate glycaemic control 3.
• The recommended dosage of dapagliflozin is 10 mg once daily, which can be added to metformin or other glucose-lowering agents 4, 5.
• In patients with heart failure and reduced ejection fraction, dapagliflozin 10 mg once daily has been shown to reduce the risk of worsening heart failure or death from cardiovascular causes 6.

Efficacy and Safety

The efficacy and safety of dapagliflozin have been evaluated in several clinical trials:

• Dapagliflozin has been shown to improve glycaemic control, reduce body weight and blood pressure, and decrease the risk of cardiovascular events in patients with T2D 3, 4, 5.
• Dapagliflozin has also been shown to reduce the risk of worsening heart failure or death from cardiovascular causes in patients with heart failure and reduced ejection fraction 6.
• The most common adverse events associated with dapagliflozin are genital infections, urinary tract infections, and hypoglycaemia 4, 5, 7.

Patient Population

Dapagliflozin can be used in a broad patient population, including:

• Patients with T2D who are intolerant of metformin or have inadequate glycaemic control with metformin alone 3, 4.
• Patients with heart failure and reduced ejection fraction, regardless of the presence or absence of diabetes 6.
• Japanese patients with T2D and inadequate glycaemic control 7.