Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 5 mg, 15 mg) |
Drug Class | Sodium glucose co-transporter 2 (SGLT2) Inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
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Summary
- Steglatro (ertugliflozin) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
- This summary is based on the review of 17 systematic review(s)/meta-analysis(es). [1-17]
- Ertugliflozin reduced HbA1c levels by -0.77% for 5 mg and -0.82% for 15 mg doses compared to placebo. A meta-analysis reported a WMD of -0.641% versus placebo and -0.215% versus other hypoglycemic agents. Ertugliflozin 15 mg showed greater HbA1c reduction than dapagliflozin 10 mg and empagliflozin 25 mg in indirect comparisons.
- Ertugliflozin reduced FPG by -1.62 mmol/L for the 5 mg dose. A WMD of -1.249 mmol/L versus placebo and -0.266 mmol/L versus other hypoglycemic agents was reported in another study.
- Ertugliflozin led to significant weight loss of -1.87 kg for the 5 mg dose and -1.774 kg in a meta-analysis.
- Ertugliflozin significantly reduced SBP by -3.64 mmHg and DBP by -1.13 mmHg. SBP reductions of -3.3 to -3.5 mmHg were noted in East/Southeast Asian patients.
- Ertugliflozin was associated with a significant increase in the risk of genital mycotic infections (RR 4.34 for 5 mg dose) but did not significantly increase the risk of urinary tract infections, hypoglycemia, acute kidney injury, diabetic ketoacidosis, or fractures.
- There were no significant differences in the incidence of serious adverse events for ertugliflozin compared to other treatments.
- Both female and male subgroups exhibited an elevated risk of genital mycotic infections with ertugliflozin.
- Ertugliflozin demonstrated significant reductions in HbA1c, FPG, body weight, and SBP in East/Southeast Asian patients, as evaluated in a dedicated post-hoc analysis.
- Studies included patients with T2DM, heart failure, and chronic kidney disease. Ertugliflozin was less effective in preventing composite cardiovascular outcomes in patients with heart failure compared to other SGLT2 inhibitors.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Steglatro (ertugliflozin) Prescribing Information. | 2023 | Merck Sharp & Dohme LLC., Rahway, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Ertugliflozin as monotherapy or with metformin for treating type 2 diabetes. | 2019 | National Institute for Health and Care Excellence |
Australian public assessment report for ertugliflozin, ertugliflozin / sitagliptin, ertugliflozin / metformin. | 2019 | Therapeutic Goods Administration |