Ertugliflozin

(Steglatro®)

Steglatro®

Drug updated on 5/17/2024

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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  • Ertugliflozin (Steglatro) is indicated as an adjunct to diet and exercise for improving glycemic control in adults with type 2 diabetes mellitus. It has been associated with a reduction in estimated glomerular filtration rate but does not significantly increase the risk of acute myocardial infarction or angina pectoris compared to placebo, suggesting cardiovascular safety comparable to other SGLT2 inhibitors.
  • The 18 studies provide comparative aspects regarding its safety and effectiveness among different populations and against other drugs within its class or broader treatment category.
  • Among sodium-glucose co-transporter 2 (SGLT2) inhibitors, certain drugs like empagliflozin and canagliflozin showed superior outcomes in specific patient subgroups. However, Ertugliflozin's effectiveness is notable among these SGLT2 inhibitors.
  • All SGLT2 inhibitors, including Ertugliflozin, have been associated with a higher risk of genital infections compared to placebo. Yet, there's no evidence to suggest that this drug poses a higher risk than others within the same group when considering dose-related adverse effects.
  • In terms of adverse events such as genital mycotic infections, Ertugliflozin shows similar risks as other agents in its class. Its incidence rates for serious adverse events or discontinuations due to these are also comparable, indicating similar tolerability profiles across competing medications.
  • When compared against placebos or other hypoglycemic agents, Steglatro demonstrates an effective reduction in HbA1c levels along with fasting plasma glucose levels while also aiding weight loss and reducing systolic/diastolic blood pressure - all key therapeutic outcomes expected from SGLT2 inhibitors.
  • Direct comparisons through network analyses suggest differences in efficacy and safety profiles among SGLT2 inhibitors. While Canagliflozin and Empagliflozin might show particular advantages in heart failure outcomes, Ertugliflozin's efficacy in lowering HbA1c levels along with its safety profile make it a viable option for patients prioritizing glycemic control and weight management.
  • The metabolism of Ertugliflozin primarily via UGT1A9 glucuronidation suggests that exposure levels are dose-proportional without significant influence from common UGT1A9 polymorphisms. This could be relevant for patient populations with genetic variations, offering Steglatro as a stable choice across diverse genetic backgrounds.

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 Open
Effectiveness and safety of ertugliflozin for type 2 diabetes: a meta-analysis of data from randomized controlled trials.2021Journal 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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