Lixisenatide

(Adlyxin®)

Adlyxin®

Drug updated on 9/4/2024

Dosage FormInjection (subcutaneous; 50 mcg/mL, 100 mcg/mL)
Drug ClassGlucagon-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.

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Summary
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  • 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 TitleYearSource
Adlyxin (lixisenatide) Prescribing Information.2023Sanofi-Aventis U.S. LLC, Bridgewater, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
GLP-1 receptor agonists and risk of adverse cerebrovascular outcomes in type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials.2022Endocrine Society
Once-daily oral semaglutide versus injectable GLP-1 RAs in people with type 2 diabetes inadequately controlled on basal insulin: Systematic review and network meta-analysis.2021Diabetes Therapy
Comparison of the effects of 10 GLP-1 RA and SGLT2 inhibitor interventions on cardiovascular, mortality, and kidney outcomes in type 2 diabetes: A network meta-analysis of large randomized trials.2021Prime Care Diabetes
Comparative efficacy of glucagon-like peptide 1 receptor agonists and sodium glucose cotransporter 2 inhibitors for prevention of major adverse cardiovascular events in type 2 diabetes: a network meta-analysis.2021Journal of Cardiovascular Pharmacology
Efficacy and safety of iGlarLixi versus IDegAsp: Results of a systematic literature review and indirect treatment comparison.2021Diabetes, Obesity and Metabolism
Gastrointestinal adverse events with insulin glargine/ lixisenatide fixed-ratio combination versus glucagon-like peptide-1 receptor agonists in people with type 2 diabetes mellitus: A network meta-analysis.2020Diabetes, Obesity and Metabolism
Insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi) compared with premix or addition of meal-time insulin to basal insulin in people with type 2 diabetes: A systematic review and Bayesian network meta-analysis.2020Diabetes, Obesity and Metabolism
Major cardiovascular events, heart failure, and atrial fibrillation in patients treated with glucagon-like peptide-1 receptor agonists: An updated meta-analysis of randomized controlled trials.2020Nutrition, Metabolism and Cardiovascular Diseases
Cardiovascular outcomes, heart failure and mortality in type 2 diabetic patients treated with glucagon-like peptide 1 receptor agonists (GLP-1 RAs): A systematic review and meta-analysis of observational cohort studies.2020International Journal of Clinical Practice
Insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi) compared with premix or addition of meal-time insulin to basal insulin in people with type 2 diabetes: a systematic review and bayesian network meta-analysis.2020Diabetes, Obesity and Metabolism
Cardiovascular, mortality, and kidney outcomes with GLP-1 receptor agonists in patients with type 2 diabetes: A systematic review and meta-analysis of cardiovascular outcome trials.2019Lancet Diabetes Endocrinology

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