Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome

• Published in: The New England journal of medicine Vol. 373; no. 23; pp. 2247 - 2257
• Main Authors: Pfeffer, Marc A, Claggett, Brian, Diaz, Rafael, Dickstein, Kenneth, Gerstein, Hertzel C, Køber, Lars V, Lawson, Francesca C, Ping, Lin, Wei, Xiaodan, Lewis, Eldrin F, Maggioni, Aldo P, McMurray, John J.V, Probstfield, Jeffrey L, Riddle, Matthew C, Solomon, Scott D, Tardif, Jean-Claude
• Format: Journal Article
• Language: English
• Published: United States Massachusetts Medical Society 03-12-2015
• Subjects: Acute Coronary Syndrome - complications; Acute Coronary Syndrome - drug therapy; Acute coronary syndromes; Aged; Angina; Angina, Unstable - complications; Cardiovascular diseases; Cardiovascular Diseases - epidemiology; Cardiovascular Diseases - prevention & control; Cerebral infarction; Clinical trials; Diabetes; Diabetes mellitus; Diabetes mellitus (non-insulin dependent); Diabetes Mellitus, Type 2 - complications; Diabetes Mellitus, Type 2 - drug therapy; Diabetes Mellitus, Type 2 - mortality; Drug dosages; Drug therapy; Female; Glucagon; Glucagon-like peptide 1; Glucagon-Like Peptide-1 Receptor - agonists; Glucose; Glycated Hemoglobin A - analysis; Heart diseases; Heart failure; Heart rate; Hemoglobin; Humans; Hypersensitivity; Hypoglycemia; Hypoglycemic Agents - adverse effects; Hypoglycemic Agents - therapeutic use; Kaplan-Meier Estimate; Male; Medicin och hälsovetenskap; Middle Aged; Morbidity; Mortality; Myocardial infarction; Myocardial Infarction - complications; Pancreas; Pancreatitis; Peptides - adverse effects; Peptides - therapeutic use; Proportional Hazards Models; Regulatory approval; Treatment Failure
• ISSN: 0028-4793; 1533-4406; 1533-4406
• DOI: 10.1056/NEJMoa1509225

In this randomized study, the addition of lixisenatide, a glucagon-like peptide 1–receptor agonist, to usual care in patients with type 2 diabetes and a recent cardiovascular event did not alter the rate of subsequent major cardiovascular or other serious adverse events.
Randomized trials involving patients with new or established type 2 diabetes have shown that improved glucose control reduces the risk of microvascular complications,
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with modest cardiovascular benefits suggested by meta-analyses and extended follow-up of clinical trials.
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However, various studies indicate that, despite being effective in lowering the glucose and glycated hemoglobin levels, some hypoglycemic medications may increase, rather than reduce, the risk of cardiovascular events.
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These unexpected findings prompted the reexamination of the regulatory approval processes for new antidiabetic therapies, which had been based primarily on the surrogate measure of glucose lowering with limited clinical-outcomes data. Since . . .