Drug updated on 9/4/2024
Dosage Form | Injection (subcutaneous; 50 mcg/mL, 100 mcg/mL) |
Drug Class | Glucagon-like peptide 1 (GLP-1) receptor agonists |
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
- Adlyxin (lixisenatide) 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 11 systematic review(s)/meta-analysis(es). [1-11]
- Cerebrovascular Outcomes: GLP-1RAs, including lixisenatide, significantly reduced the risk of adverse cerebrovascular outcomes (RR, 0.83; 95% CI, 0.76-0.91), nonfatal stroke (RR, 0.85; 95% CI, 0.76-0.94), and ischemic stroke (RR, 0.73; 95% CI, 0.60-0.89), but did not significantly reduce the risk of fatal stroke (RR, 0.80; 95% CI, 0.61-1.05) or hemorrhagic stroke (RR, 0.92; 95% CI, 0.51-1.64).
- Glycemic Control and Weight Reduction: Once-daily oral semaglutide 14 mg achieved greater reductions in HbA1c (treatment differences: -0.42 to -1.32%) and weight (treatment differences: -2.21 and -2.39 kg) compared to lixisenatide.
- Cardiorenal Events: Lixisenatide was less effective in reducing major adverse cardiovascular events (HR 0.73, 95% CI 0.55-0.96) and hospitalization for heart failure/kidney function progression compared to other GLP-1 RAs such as semaglutide and dapagliflozin.
- Other Cardiovascular and Mortality Outcomes: GLP-1 receptor agonists, including lixisenatide, significantly reduced major adverse cardiovascular events (MH-OR 0.87) and all-cause mortality (MH-OR 0.89) but had neutral effects on atrial fibrillation (MH-OR 0.94).
- Lixisenatide was associated with gastrointestinal adverse events, particularly nausea, vomiting, and diarrhea, with iGlarLixi showing lower rates of nausea and vomiting compared to single-agent GLP-1 RAs like exenatide and liraglutide. 8. iGlarLixi demonstrated lower rates of both confirmed and documented symptomatic hypoglycemia compared to premix insulin, with comparisons to other drugs being inconclusive due to differing study definitions.
- There was no significant increase in the risk of severe hypoglycemia, pancreatitis, or pancreatic cancer with GLP-1RAs, including lixisenatide.
- Benefits of GLP-1RAs were higher in patients with shorter T2DM duration and higher eGFR; Japanese trials showed greater HbA1c reductions compared to international trials; subgroups with cardiovascular disease, heart failure, and chronic kidney disease showed varying effectiveness among different GLP-1RAs.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Adlyxin (lixisenatide) Prescribing Information. | 2023 | Sanofi-Aventis U.S. LLC, Bridgewater, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Improving Care and Promoting Health in Populations: Standards of Care in Diabetes—2023. | 2023 | American Diabetes Association |
2023 UPDATE: Luso-Brazilian evidence-based guideline for the management of antidiabetic therapy in type 2 diabetes. | 2023 | Diabetology & Metabolic Syndrome |
2023 clinical practice guidelines for diabetes mellitus of the Korean Diabetes Association. | 2023 | Diabetes and Metabolism Journal |
Management of hyperglycemia in type 2 diabetes, 2022. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). | 2022 | Diabetes Care |
Recent updates to clinical practice guidelines for diabetes mellitus. | 2022 | Endocrinology and Metabolism |
2021 Clinical practice guidelines for diabetes mellitus in Korea. | 2021 | Diabetes and Metabolism Journal |
Japanese clinical practice guideline for diabetes 2019. | 2019 | Journal of Diabetes Investigation |