6/28/23, 9:53 PM ELIXA Pathway Feedback Search Clinical Topics Home Studies ELIXA ELIXA Disease Disease Disease Diabetes mellitus type 2 In-hospital hyperglycemia Non-ST Trial question What is the role of lixisenatide in patients with T2DM and acute coronary syndrome? Study design Multi-center Double blinded RCT Population Characteristics of study participants 31.0% female N = 6068 69.0% male 6068 patients (1861 female, 4207 male) Inclusion criteria: patients with T2DM who had had a myocardial infarction or who had been hospitalized for unstable angina within the previous 180 days Key exclusion criteria: age < 30 years, PCI within the previous 15 days, CABG surgery for the qualifying event, planned coronary revascularization procedure within 90 days after screening, an eGFR < 30 mL/min/1.73 m of body-surface area, a glycated Hgb level < 5.5% or > 11.0% Interventions N=3034 lixisenatide (a dose of 10 g/day for first 2 weeks and increased to a maximum dose of 20 g/day) N=3034 placebo (volume matched placebo per day) Primary outcome Cardiovascular death, myocardial infarction, stroke, or hospitalization for unstable angina 13.4 13.4 % 13.2 https://web.pathway.md/studies/recpAVOksmJfkJfnQ 1/2 6/28/23, 9:53 PM ELIXA Pathway 10.1 % 6.7 % 3.4 % No significant difference 0.0 % Lixisenatide Placebo No significant difference in cardiovascular death, myocardial infarction, stroke, or hospitalization for unstable angina (13.4% vs. 13.2%; HR 1.02, 95% CI 0.89 to 1.17) Secondary outcomes No significant difference in hospitalization for HF (4% vs. 4.2%; HR 0.96, 96% CI 0.75 to 1.23) No significant difference in death (7% vs. 7.4%; HR 0.94, 95% CI 0.78 to 1.13) Safety outcomes No significant differences in serious adverse events or severe hypoglycemia, pancreatitis, pancreatic neoplasms, or allergic reactions. Conclusion In patients with T2DM who had had a myocardial infarction or who had been hospitalized for unstable angina within the previous 180 days, lixisenatide was not superior to placebo with respect to cardiovascular death, myocardial infarction, stroke, or hospitalization for unstable angina. Reference Pfeffer MA, Claggett B, Diaz R et al. Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome. N Engl J Med. 2015 Dec 3;373(23):2247-57. Open reference URL https://web.pathway.md/studies/recpAVOksmJfkJfnQ 2/2