Ertugliflozin

(Steglatro®)

Ertugliflozin

Drug updated on 9/4/2024

Dosage FormTablet (oral; 5 mg, 15 mg)
Drug ClassSodium 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
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  • 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 TitleYearSource
Steglatro (ertugliflozin) Prescribing Information.2023Merck Sharp & Dohme LLC., Rahway, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Effect of ertugliflozin on renal function and cardiovascular outcomes in patients with type 2 diabetes mellitus: a systematic review and meta-analysis.2023Medicine
A model-based meta analysis study of sodium glucose co-transporter-2 inhibitors.2023CPT: Pharmacometrics & Systems Pharmacology
Impact of SGLT2 inhibitors on patient outcomes: a network meta-analysis.2023Cardiovascular Diabetology
Comparative cardiovascular benefits of individual SGLT2 inhibitors in type 2 diabetes and heart failure: a systematic review and network meta-analysis of randomized controlled trials.2023Frontiers in Endocrinology
Comparative safety of different recommended doses of sodium-glucose cotransporter 2 inhibitors in patients with type 2 diabetes mellitus: a systematic review and network meta-analysis of randomized clinical trials.2023Frontiers in Endocrinology
The efficacy of Sodium-Glucose Cotransporter-2 Inhibitors in improving morbidity and mortality of heart failure: a systematic review.2022Cureus
Efficacy and safety of ertugliflozin in type 2 diabetes: a systematic review and meta-analysis. 2022Frontiers in Pharmacology
Association of SGLT2 inhibitors with risk of atrial fibrillation and stroke in patients with and without type 2 diabetes: a systemic review and meta-analysis of randomized controlled trials.2022Journal of Cardiovascular Pharmacology
Renal protective effect and safety of sodium-glucose cotransporter-2 inhibitors in patients with chronic kidney disease and type 2 diabetes mellitus: a network meta-analysis and systematic review.2022International Urology and Nephrology
Effectiveness and safety of ertugliflozin for type 2 diabetes: a meta-analysis of data from randomized controlled trials.2022Journal of Diabetes Investigation
Effect of sodium-dependent glucose transporter inhibitors on glycated hemoglobin A1c after 24 weeks in patients with diabetes mellitus: a systematic review and meta-analysis.2021Medicine
Safety and efficacy of SGLT2 inhibitors: a multiple-treatment meta-analysis of clinical decision indicators.2021Journal of Clinical Medicine
Comparative efficacy of dual and single initiation of add-on oral antihyperglycemic agents in type 2 diabetes uncontrolled on metformin alone: a systematic literature review and network meta-analysis.2021Diabetes Therapy
Meta-analysis of noncompartmental pharmacokinetic parameters of ertugliflozin to evaluate dose proportionality and UGT1A9 polymorphism effect on exposure.2021Pharmacogenomics
Effect of ertugliflozin on glycemic levels, blood pressure and body weight of patients with type 2 diabetes mellitus: a systematic review and meta-analysis.2020Journal of Diabetes & Metabolic Disorders
Efficacy and safety of ertugliflozin in East/Southeast Asian patients with type 2 diabetes mellitus.2020Diabetes, Obesity and Metabolism
Ertugliflozin compared to other anti-hyperglycemic agents as monotherapy and add-on therapy in type 2 diabetes: a systematic literature review and network meta-analysis.2019Diabetes Therapy

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