Steglatro (Ertugliflozin) Indications
Steglatro is FDA-approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 1
Primary Indication: Type 2 Diabetes Management
Steglatro functions as an SGLT2 inhibitor that blocks glucose reabsorption in the kidneys, increasing urinary glucose excretion to lower blood sugar levels. 1, 2
Mechanism and Glycemic Benefits
- Ertugliflozin inhibits SGLT2 proteins in the proximal renal tubules, reducing glucose reabsorption and promoting glucosuria 3, 4
- The medication works independently of insulin secretion or action, making it effective regardless of diabetes duration 3
- Clinical trials demonstrate HbA1c reductions of 0.6-1%, fasting plasma glucose reductions of 30-50 mg/dL, and 2-hour postprandial glucose reductions of 60-70 mg/dL 5
Additional Metabolic Benefits
- Body weight reduction of 2-3 kg has been consistently observed in clinical trials 5
- Blood pressure lowering of 3-5 mmHg systolic occurs as a secondary benefit 2, 5
- These effects occur with a low intrinsic risk of hypoglycemia when used as monotherapy 2
Cardiovascular Outcomes Evidence
The VERTIS-CV trial demonstrated that ertugliflozin is cardiovascularly safe in patients with type 2 diabetes and established atherosclerotic cardiovascular disease, meeting noninferiority criteria for major adverse cardiovascular events. 6
Heart Failure Benefits
- Ertugliflozin reduced hospitalizations for heart failure with a hazard ratio of 0.70 (95% CI 0.54-0.90), consistent with other SGLT2 inhibitors 6
- This heart failure benefit appears to be a class effect of SGLT2 inhibitors 5
Cardiovascular Safety Profile
- The primary outcome of major adverse cardiovascular events occurred in 11.9% of both ertugliflozin and placebo groups (HR 0.97,95% CI 0.85-1.11) 6
- Unlike empagliflozin and canagliflozin, ertugliflozin did not demonstrate superiority for reducing cardiovascular death or the composite of cardiovascular death plus heart failure hospitalization 6, 5
Important Limitations and Contraindications
Steglatro is NOT recommended for type 1 diabetes mellitus to improve glycemic control. 1
Renal Function Restrictions
- Use is not recommended when eGFR is less than 45 mL/min/1.73 m² 1
- Assess renal function before initiating and monitor as clinically indicated 1
- Ertugliflozin progressively loses glucose-lowering efficacy as eGFR declines, with substantially reduced effects below 30 mL/min/1.73 m² 7
Surgical Precautions
- Withhold Steglatro for at least 4 days prior to surgery or procedures with prolonged fasting to prevent diabetic ketoacidosis 1
Dosing Strategy
- The recommended starting dose is 5 mg orally once daily, taken in the morning with or without food 1
- Increase to 15 mg once daily in patients tolerating the medication who need additional glycemic control 1
- Correct volume depletion before initiating therapy 1
Key Safety Considerations
Monitor for diabetic ketoacidosis regardless of blood glucose levels, as SGLT2 inhibitors can cause euglycemic ketoacidosis. 1
Critical Adverse Events to Monitor
- Lower limb infections or ulcers requiring potential amputation (discontinue if these occur) 1
- Volume depletion leading to acute kidney injury, particularly in elderly patients, those on diuretics, or with baseline renal impairment 1
- Urosepsis and pyelonephritis (evaluate and treat urinary tract infections promptly) 1
- Necrotizing fasciitis of the perineum (Fournier's gangrene) - a rare but life-threatening infection 1
- Genital mycotic infections (most common adverse reaction, occurring in ≥5% of patients) 1
Hypoglycemia Risk Management
- When combining with insulin or insulin secretagogues, consider dose reduction of these agents to minimize hypoglycemia risk 1
Comparison to Other SGLT2 Inhibitors
Ertugliflozin is among the most selective SGLT2 inhibitors, similar to empagliflozin and dapagliflozin, distinguishing it from less selective agents like canagliflozin. 3, 8