Lixisenatide — clinical evidence
Assessed outcomes with certainty ratings, contributing trials and the reasoning for each rating.
§3Clinical evidence
§3.1Atherosclerotic cardiovascular disease and cardiovascular risk reduction
Anchor outcome. Three-point major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke).
Effect as recorded. MACE hazard ratio 1.02 — neutral; HR 1.02 (95 % CI 0.89 to 1.17).[1,2]
Certainty. High certainty A clearly neutral event-driven result in a post-acute-coronary-syndrome population. The Institute cites ELIXA whenever the assertion of a class-wide cardiovascular benefit is made.
Contributing trials. ELIXA. Full structured abstracts are published for each.
Full evidence extract for atherosclerotic cardiovascular disease and cardiovascular risk reduction · Indication assessment
§3.2Type 2 diabetes mellitus
Anchor outcome. Change in HbA1c (%, mmol/mol).
Effect as recorded. −0.7 to −0.9 % HbA1c at 24 weeks with pronounced postprandial glucose reduction; GetGoal-M difference versus placebo −0.5 % (95 % CI −0.7 to −0.4).[2,3]
Certainty. High certainty Smaller HbA1c effect than the long-acting agents, with a distinctly different postprandial profile.
Contributing trials. GETGOAL-M · GETGOAL-L · GETGOAL-DUO-1. Full structured abstracts are published for each.
Full evidence extract for type 2 diabetes mellitus · Indication assessment
§3.3Obesity and overweight in adults
Anchor outcome. Percentage change in body weight from baseline.
Effect as recorded. −1.8 to −2.7 kg; modest.[3,4]
Certainty. Moderate certainty No obesity programme.
Contributing trials. GETGOAL-M. Full structured abstracts are published for each.
Full evidence extract for obesity and overweight in adults · Indication assessment
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Pfeffer MA, Claggett B, Diaz R, Dickstein K, Gerstein HC, Køber LV, Lawson FC, Ping L, Wei X, Lewis EF, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Solomon SD, Tardif JC. Lixisenatide in patients with type 2 diabetes and acute coronary syndrome. New England Journal of Medicine 2015;373(23):2247–2257. doi:10.1056/NEJMoa1509225 · PMID 26630143
- Drucker DJ. Mechanisms of action and therapeutic application of glucagon-like peptide-1. Cell Metabolism 2018;27(4):740–756. doi:10.1016/j.cmet.2018.03.001 · PMID 29617641
- Nauck MA, Quast DR, Wefers J, Meier JJ. GLP-1 receptor agonists in the treatment of type 2 diabetes — state-of-the-art. Molecular Metabolism 2021;46:101102. doi:10.1016/j.molmet.2020.101102 · PMID 33068776
- D’Hondt M, Bracke N, Taevernier L, Gevaert B, Verbeke F, Wynendaele E, De Spiegeleer B. Related impurities in peptide medicines. Journal of Pharmaceutical and Biomedical Analysis 2014;101:2–30. doi:10.1016/j.jpba.2014.06.012 · PMID 25044089
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.