What monitoring is required when initiating Empagliflozin (Empagliflozin) therapy?

From the Guidelines

When initiating empagliflozin, patients should have baseline renal function, blood pressure, and volume status assessed before starting therapy, and monitoring should include renal function, blood pressure, blood glucose, and HbA1c, with more frequent monitoring in patients with eGFR <60 mL/min/1.73m², as recommended by the KDIGO 2022 clinical practice guideline for diabetes management in chronic kidney disease 1.

Key Monitoring Parameters

• Baseline renal function, including estimated glomerular filtration rate (eGFR) and albumin-creatinine ratio (ACR)
• Blood pressure, with regular checks due to the diuretic effect of empagliflozin
• Blood glucose and HbA1c, to assess glycemic efficacy
• Volume status, particularly in elderly patients or those on diuretics, to monitor for intravascular volume depletion

Patient Education and Safety Considerations

• Patients should be educated about potential genital mycotic infections and urinary tract infections, and instructed to report symptoms promptly
• Watch for signs of diabetic ketoacidosis (DKA), even with normal blood glucose levels, especially during illness or reduced food intake
• Empagliflozin should be temporarily discontinued before surgical procedures or during acute illness to reduce the risk of euglycemic DKA, as per the recommendations for periprocedural/perioperative care 1

Clinical Considerations

• The medication can cause a mild and transient drop in eGFR, but offers long-term kidney protection, as noted in the EMPEROR-Reduced trial 1
• Treatment benefits with SGLT2 inhibitors, such as empagliflozin, occur soon after drug initiation, and independently of age, sex, or background medical therapy 1
• Empagliflozin has a favorable safety profile, with a low risk of hypoglycemia, lower limb amputations, bone fracture, and diabetic ketoacidosis, making it a suitable treatment option for patients with type 2 diabetes and chronic kidney disease 1

From the FDA Drug Label

Assess renal function before initiating JARDIANCE. Do not initiate JARDIANCE if eGFR is below 45 mL/min/1.73 m2 Hypotension: Before initiating JARDIANCE assess and correct volume status in patients with renal impairment, the elderly, in patients with low systolic blood pressure, and in patients on diuretics. Monitor for signs and symptoms during therapy. Ketoacidosis: Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue JARDIANCE, evaluate and treat promptly. Before initiating JARDIANCE, consider risk factors for ketoacidosis Acute kidney injury and impairment in renal function: Consider temporarily discontinuing in settings of reduced oral intake or fluid losses. If acute kidney injury occurs, discontinue and promptly treat. Monitor renal function during therapy.

Monitoring on initiation of empagliflozin includes:

• Assessing renal function before initiating the drug
• Assessing and correcting volume status in patients with renal impairment, the elderly, in patients with low systolic blood pressure, and in patients on diuretics
• Monitoring for signs and symptoms of hypotension, ketoacidosis, and acute kidney injury during therapy
• Considering risk factors for ketoacidosis before initiating the drug 2

From the Research

Empagliflozin Monitoring on Initiation

• Empagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor that has been shown to have beneficial effects on glycemic control, glucose metabolism, and cardiovascular outcomes 3.
• When initiating empagliflozin, it is essential to monitor patients for potential side effects, such as symptomatic hypotension, genital fungal infections, urinary tract infections, and rare ketoacidosis 3.
• The EMPA-REG OUTCOME trial demonstrated that empagliflozin reduced the risk of cardiovascular events and kidney outcomes in patients with type 2 diabetes and established cardiovascular disease 4.
• In patients with chronic kidney disease, empagliflozin has been shown to have positive cardiorenal effects, including a reduction in the risk of kidney disease progression and cardiovascular death 5.

Key Monitoring Parameters

• Glycated hemoglobin (HbA1c) levels: Empagliflozin has been shown to reduce HbA1c levels in patients with type 2 diabetes 6.
• Urinary albumin-to-creatinine ratio (UACR): Empagliflozin has been shown to reduce UACR in patients with type 2 diabetes and established cardiovascular disease 4, 7.
• Blood pressure: Empagliflozin has been shown to reduce blood pressure in patients with type 2 diabetes 6.
• Kidney function: Empagliflozin has been shown to slow the progression of kidney disease in patients with chronic kidney disease 5.

Special Considerations

• Patients with severe hypersensitivity reaction to empagliflozin or a glomerular filtration rate (GFR) < 30 mL/min/1.73 m2 should not receive empagliflozin 3.
• Patients with increased albuminuria may require closer monitoring of kidney function and UACR 7.
• The use of open-label SGLT2 inhibitors, including empagliflozin, may be similar in patients with chronic kidney disease, regardless of treatment group 5.