ELIXA
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
69.0% male
N = 6068
6068 patients (1861 female, 4207 male).
Inclusion criteria: patients with T2DM who had had a MI 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 m² of body-surface area, a glycated hemoglobin level < 5.5% or > 11.0%.
Interventions
N=3034 lixisenatide (a dose of 10 mcg/day for first 2 weeks and increased to a maximum dose of 20 mcg/day).
N=3034 placebo (volume matched placebo per day).
Primary outcome
CV death, MI, stroke, or hospitalization for unstable angina
13.4%
13.2%
13.4 %
10.1 %
6.7 %
3.4 %
0.0 %
Lixisenatide
Placebo
No significant
difference ↔
No significant difference in CV death, MI, 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 MI or who had been hospitalized for unstable angina within the previous 180 days, lixisenatide was not superior to placebo with respect to CV 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.
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