From the Guidelines
Empagliflozin (Jardiance) is a highly effective medication for managing type 2 diabetes mellitus, particularly in patients with established cardiovascular disease, as it has been shown to reduce the risk of major adverse cardiovascular events and cardiovascular death by 14% and 38%, respectively, as demonstrated in the EMPA-REG OUTCOME trial 1.
Key Benefits and Considerations
- Empagliflozin works by increasing glucose excretion through the kidneys and offers benefits beyond glucose control, including weight loss, blood pressure reduction, and significant cardiovascular and kidney protection.
- The standard dosing is 10 mg once daily, which can be increased to 25 mg daily if needed for better glycemic control.
- It should be taken in the morning with or without food and works best when combined with a healthy diet and exercise.
- Common side effects include genital yeast infections and increased urination, and patients should maintain adequate hydration while taking this medication.
- Empagliflozin is contraindicated in patients with type 1 diabetes, severe kidney disease (eGFR <30 mL/min/1.73m²), or a history of diabetic ketoacidosis.
Clinical Evidence and Recommendations
- The EMPA-REG OUTCOME trial, a randomized, double-blind trial, assessed the effect of empagliflozin versus placebo on cardiovascular outcomes in 7,020 patients with type 2 diabetes and existing cardiovascular disease, showing a significant reduction in major adverse cardiovascular events and cardiovascular death 1.
- The Canagliflozin Cardiovascular Assessment Study (CANVAS) Program and the CREDENCE trial also demonstrated the cardiovascular and renal benefits of SGLT2 inhibitors in patients with type 2 diabetes and established cardiovascular disease or chronic kidney disease 1.
- The 2022 guideline recommended the use of SGLT2 inhibitors, including empagliflozin, for kidney and heart failure outcomes in patients with type 2 diabetes and CKD, with an eGFR of 25-45 mL/min/1.73m² 1.
Patient Selection and Monitoring
- Empagliflozin may be more useful for patients at high risk of CKD progression, such as those with albuminuria or a history of documented eGFR loss.
- Patients should be monitored for adverse events, including genital yeast infections, increased urination, and changes in kidney function.
- Empagliflozin can be started with an eGFR >30 mL/min/1.73m², although pivotal trials have demonstrated benefit in subgroups with low eGFR.
From the FDA Drug Label
JARDIANCE is indicated: as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease. The role of Empagliflozin (Jardiance) in managing type 2 diabetes mellitus is:
- Improving glycemic control: as an adjunct to diet and exercise in adults with type 2 diabetes mellitus.
- Reducing cardiovascular risk: to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease 2, 2, 2.
From the Research
Role of Empagliflozin in Managing Type 2 Diabetes Mellitus
Empagliflozin, also known as Jardiance, plays a significant role in managing type 2 diabetes mellitus. The key aspects of its role can be summarized as follows:
- Empagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor that reduces cardiovascular morbidity and mortality in patients with type 2 diabetes mellitus and established cardiovascular disease 3.
- It has been shown to improve clinical outcomes and reduce mortality in vulnerable patients with type 2 diabetes mellitus, established cardiovascular disease, and chronic kidney disease 3.
- The efficacy and safety of empagliflozin have been evaluated in various studies, including a network meta-analysis that found 25 mg to be the most effective dose in terms of lowering HbA1c and FPG, while also considering safety 4.
Mechanism of Action and Benefits
The mechanism of action of empagliflozin involves inhibiting the reabsorption of glucose in the kidneys, leading to increased urinary glucose excretion and reduced blood glucose levels. The benefits of empagliflozin include:
- Improved glycemic control 5, 6
- Reduced risk of cardiovascular events, including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke 3, 6
- Reduced risk of hospitalization for heart failure and renal adverse events 6
- Modest reductions in body weight and blood pressure 5
Safety and Tolerability
Empagliflozin is generally well tolerated, with common adverse events including genital mycotic infections, urinary tract infections, and events linked to volume depletion 5, 7. However, it has not been associated with an increased risk of amputation or bone fractures, unlike some other SGLT2 inhibitors 5.
Clinical Use
Empagliflozin is a valuable treatment option for the management of type 2 diabetes mellitus, particularly in patients with established cardiovascular disease or at high risk of cardiovascular events 5, 6. It can be used as monotherapy or in combination with other antidiabetic agents, and its use should be considered on an individual patient basis, taking into account factors such as renal function and cardiovascular risk 3, 6.