Drug updated on 12/11/2024
Dosage Form | Tablet (oral; 20 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
Summary
- This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
- Bexagliflozin demonstrated non-inferiority in reducing major adverse cardiovascular events (MACE+), with a hazard ratio (HR) of 0.80 (95% confidence interval (CI), 0.58 to 1.09). For MACE, the HR was 0.82 (95% CI, 0.59 to 1.13).
- In glycemic control, bexagliflozin significantly reduced Hemoglobin A1c (HbA1c) by -0.45 (95% CI: -0.55 to -0.34), Fasting Plasma Glucose (FPG) by -1.37 (95% CI: -1.73 to -1.00), body weight by -1.77 kg (95% CI: -2.44 to -1.10), and systolic blood pressure by -4.11 mmHg (95% CI: -6.18 to -2.03).
- Bexagliflozin showed a renal protective effect with a reduction in estimated Glomerular Filtration Rate (eGFR) of -3.48 (95% CI: -6.57 to -0.39), comparable to other Sodium-Glucose Cotransporter 2 (SGLT2) inhibitors such as dapagliflozin and luseogliflozin.
- Bexagliflozin did not increase the risk of MACE in participants with type 2 diabetes mellitus (T2DM), with safety outcomes consistent with the placebo arm.
- Renal safety outcomes indicated a reduction in eGFR, similar to other SGLT2 inhibitors like luseogliflozin and dapagliflozin, without a significant increase in adverse renal events.
- The studies focused on participants with T2DM and chronic kidney disease, with no significant differences in effectiveness or safety among various population types or subgroups explicitly reported in the provided documents.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Brenzavvy (bexagliflozin) Prescribing Information. | 2023 | TheracosBio LLC, Marlborough, MA |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Meta-analysis of risk of major adverse cardiovascular events in adults with type 2 diabetes treated with bexagliflozin | 2024 | Diabetes, Obesity and Metabolism |
Bexagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, for improvement of glycemia in type 2 diabetes mellitus: a systematic review and meta-analysis | 2023 | Expert Opinion on Pharmacotherapy |
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 | 2022 | International Urology and Nephrology |