Ertugliflozin

(Steglatro®)

Steglatro®

Drug updated on 10/30/2024

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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  • This summary is based on the review of 43 systematic review(s)/meta-analysis(es). [1-43]
  • HbA1c Reduction: Ertugliflozin showed a significant reduction in HbA1c levels compared to placebo, with a mean difference (MD) of -0.62% (95% CI [-0.80, -0.44]) for 5 mg and -0.69% (95% CI [-0.91, -0.47]) for 15 mg. Reductions were comparable to other SGLT2 inhibitors.
  • Fasting Plasma Glucose (FPG): Significant reductions in FPG were observed with both 5 mg and 15 mg doses of ertugliflozin compared to placebo and other hypoglycemic agents.
  • Body Weight Reduction: Ertugliflozin significantly reduced body weight, with more pronounced effects at the 15 mg dose. Its efficacy in weight reduction was similar to other SGLT2 inhibitors.
  • Cardiovascular Outcomes: Ertugliflozin reduced hospitalizations for heart failure (HR 0.70, 95% CI 0.54-0.90) but had a borderline effect on major adverse cardiovascular events (MACEs), with slightly less efficacy compared to empagliflozin and canagliflozin.
  • Adverse Events: Ertugliflozin's adverse event profile was comparable to placebo, except for a higher incidence of genital mycotic infections, particularly in female patients, with consistent findings across doses and populations.
  • Other Safety Concerns: There were no significant differences in the risk of serious adverse events, including hypoglycemia, urinary tract infections, acute kidney injury, fractures, or cardiovascular adverse events, compared to placebo.
  • There is no population types or subgroups information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Steglatro (ertugliflozin) Prescribing Information.2024Merck & Co., Inc., Rahway, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy and Safety of Ertugliflozin Compared to Placebo in Patients With Type 2 Diabetes: An Updated Systematic Review and Meta-Analysis2024Journal of Diabetes Research
Examining the Impact of Ertugliflozin on Cardiovascular Outcomes in Patients with Diabetes and Metabolic Syndrome: A Systematic Review of Clinical Trials2024Pharmaceuticals
Association of Sodium-Glucose Cotransporter 2 Inhibitors (SGLT2i) with Cardiac Arrhythmias: A Systematic Review and Meta-Analysis of Cardiovascular Outcome Trials2023Reviews in Cardiovascular Medicine
Comparative cardiovascular benefits of individual SGLT2 inhibitors in type 2 diabetes and heart failure: a systematic review and network meta-analysis of randomized controlled trials2023Frontiers 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 trials2023Frontiers in Endocrinology
Longitudinal efficacy of Ertugliflozin in type 2 diabetes mellitus: a meta-analysis of randomized controlled trials2023Expert Opinion on Pharmacotherapy
Impact of SGLT2 inhibitors on patient outcomes: a network meta-analysis2023Cardiovascular Diabetology
Comparative safety of different sodium-glucose transporter 2 inhibitors in patients with type 2 diabetes: a systematic review and network meta-analysis of randomized controlled trials2023Frontiers in Endocrinology
Dose-dependent renoprotection efficacy of sglt2 inhibitors in type 2 diabetes: systematic review and network meta-analysis2023Acta Diabetologica
Impact of sodium-glucose co-transporter 2 inhibitors on renal outcomes in patients of diabetes mellitus: A meta-analysis of landmark renal and cardiovascular outcome trials2023Indian Journal of Pharmacology
Systematic review of sodium-glucose cotransporter 2 inhibitors: a hopeful prospect in tackling heart failure-related events2023ESC Heart Failure
The Efficacy of Sodium-Glucose Cotransporter-2 Inhibitors in Improving Morbidity and Mortality of Heart Failure: A Systematic Review2023Cureus
Neutral effects of SGLT2 inhibitors in acute coronary syndromes, peripheral arterial occlusive disease, or ischemic stroke: a meta-analysis of randomized controlled trials2023Cardiovascular Diabetology
Effect of ertugliflozin on renal function and cardiovascular outcomes in patients with type 2 diabetes mellitus: A systematic review and meta-analysis2023Medicine
A model-based meta analysis study of sodium glucose co-transporter-2 inhibitors2023CPT: Pharmacometrics & Systems Pharmacology
Cardiovascular outcomes in patients treated with sodium-glucose transport protein 2 inhibitors, a network meta-analysis of randomized trials2022Frontiers in Cardiovascular Medicine
Cardiovascular and renal outcomes with sodium glucose co-transporter 2 inhibitors in patients with type 2 diabetes mellitus: A system review and network meta-analysis2022Frontiers in Pharmacology
Relationship Between SGLT-2i and Ocular Diseases in Patients With Type 2 Diabetes Mellitus: A Meta-Analysis of Randomized Controlled Trials2022Frontiers in endocrinology
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 review2022International Urology and Nephrology
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 Trials2022Journal of Cardiovascular Pharmacology
Effectiveness and safety of ertugliflozin for type 2 diabetes: A meta-analysis of data from randomized controlled trials2022Journal of Diabetes Investigation
Efficacy and Safety of Ertugliflozin in Type 2 Diabetes: A Systematic Review and Meta-Analysis2021Frontiers in Pharmacology
SGLT-2 inhibitors and cardiorenal outcomes in patients with or without type 2 diabetes: a meta-analysis of 11 CVOTs2021Cardiovascular Diabetology
Gliflozins for the prevention of stroke in diabetes and cardiorenal diseases: A meta-analysis of cardiovascular outcome trials2021Medicine
Sodium-Glucose Cotransporter 2 Inhibitors, All-Cause Mortality, and Cardiovascular Outcomes in Adults with Type 2 Diabetes: A Bayesian Meta-Analysis and Meta-Regression2021Journal of the American Heart Association
Comparative efficacy of 5 sodium glucose cotransporter 2 inhibitor and 7 glucagon-like peptide 1 receptor agonists interventions on cardiorenal outcomes in type 2 diabetes patients: A network meta-analysis based on cardiovascular or renal outcome trials2021Medicine
Anti-diabetic drugs and weight loss in patients with type 2 diabetes2021Pharmacological Research
SGLT-2i and Risk of Malignancy in Type 2 Diabetes: A Meta-Analysis of Randomized Controlled Trials2021Frontiers in Public Health
The effects of sodium glucose co-transporter (SGLT) 2 inhibitors on hematocrit levels: a systematic review and meta-analysis of randomized controlled trials2021Annals of Palliative Medicine
Comparative efficacy of glucose-lowering medications on body weight and blood pressure in patients with type 2 diabetes: A systematic review and network meta-analysis2021Diabetes, Obesity & Metabolism
Comparison of New Oral Hypoglycemic Agents on Risk of Urinary Tract and Genital Infections in Type 2 Diabetes: A Network Meta-analysis2021Advances in Therapy
Safety of four SGLT2 inhibitors in three chronic diseases: A meta-analysis of large randomized trials of SGLT2 inhibitors2021Diabetes & Vascular Disease Research
Meta-Analysis of Noncompartmental Pharmacokinetic Parameters of Ertugliflozin to Evaluate Dose Proportionality and UGT1A9 Polymorphism Effect on Exposure2021Journal of Clinical Pharmacology
Association of SGLT2 inhibitors with arrhythmias and sudden cardiac death in patients with type 2 diabetes or heart failure: A meta-analysis of 34 randomized controlled trials2021Heart Rhythm
Effect of sodium-dependent glucose transporter inhibitors on glycated hemoglobin A1c after 24 weeks in patients with diabetes mellitus: A systematic review and meta-analysis2021Medicine
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-Analysis2021Diabetes Therapy
Comparative efficacy of sodium-glucose cotransporter-2 inhibitors (SGLT2i) for cardiovascular outcomes in type 2 diabetes: a systematic review and network meta-analysis of randomised controlled trials2021Heart Failure Reviews
Safety of Ertugliflozin in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Conventional Therapy at Different Periods: A Meta-Analysis of Randomized Controlled Trials2020Journal of Diabetes Research
Effect of ertugliflozin on glycemic levels, blood pressure and body weight of patients with type 2 diabetes mellitus: a systematic review and meta-analysis2020Journal of Diabetes and Metabolic Disorders
Sodium-glucose co-transporter-2 inhibitors and major adverse limb events: A trial-level meta-analysis including 51 713 individuals2020Diabetes, Obesity & Metabolism
Efficacy and safety of ertugliflozin in older patients with type 2 diabetes: A pooled analysis of phase III studies2020Diabetes, Obesity & Metabolism
Association between sodium-glucose cotransporter 2 (SGLT2) inhibitors and lower extremity amputation: A systematic review and meta-analysis2020PLoS One
Efficacy and safety of ertugliflozin in East/Southeast Asian patients with type 2 diabetes mellitus2020Diabetes, Obesity & Metabolism

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