Drug updated on 5/17/2024
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.
Latest News
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Summary
- 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 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 |