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Exenatide: difference between revisions

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Revision 19 — 11:05, 12 Jul 2025
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35The suspension also requires reconstitution and vigorous mixing immediately before injection, a preparation burden that later single-solution products removed.35The suspension also requires reconstitution and vigorous mixing immediately before injection, a preparation burden that later single-solution products removed.
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+37== Clinical position ==
+38Exenatide reduces glycated haemoglobin by roughly 0.8–1.5 percentage points depending on formulation and background therapy, with modest weight reduction. The EXSCEL cardiovascular outcome trial of the extended-release product reported a hazard ratio of 0.91 (95% CI 0.83–1.00) for the primary composite, narrowly failing conventional significance for superiority while establishing non-inferiority.{{r|holman2017}}
+39
+40That result is worth noting whenever a cardiovascular benefit is described as a class effect: within the same class, [[LEADER trial|LEADER]] and [[SELECT trial|SELECT]] were positive, EXSCEL was neutral, and the outcome trial of lixisenatide was neutral. Whether the differences reflect molecule, dose, population or duration is unresolved.{{r|holman2017}}
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37== References ==42== References ==
38{{reflist}}43{{reflist}}
39<ref name="nielsen2004">Nielsen LL, Young AA, Parkes DG. "Pharmacology of exenatide (synthetic exendin-4): a potential therapeutic for improved glycemic control of type 2 diabetes." ''Regulatory Peptides'' 117(2):77–88 (2004). PMID 14700743.</ref>44<ref name="nielsen2004">Nielsen LL, Young AA, Parkes DG. "Pharmacology of exenatide (synthetic exendin-4): a potential therapeutic for improved glycemic control of type 2 diabetes." ''Regulatory Peptides'' 117(2):77–88 (2004). PMID 14700743.</ref>
40<ref name="drucker2018">Drucker DJ. "Mechanisms of action and therapeutic application of glucagon-like peptide-1." ''Cell Metabolism'' 27(4):740–756 (2018). PMID 29617641.</ref>45<ref name="drucker2018">Drucker DJ. "Mechanisms of action and therapeutic application of glucagon-like peptide-1." ''Cell Metabolism'' 27(4):740–756 (2018). PMID 29617641.</ref>
+46<ref name="holman2017">Holman RR, Bethel MA, Mentz RJ, et al. "Effects of once-weekly exenatide on cardiovascular outcomes in type 2 diabetes." ''New England Journal of Medicine'' 377(13):1228–1239 (2017). DOI:10.1056/NEJMoa1612917. PMID 28910237.</ref>
41<ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref>47<ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref>
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