New England Journal of Medicine· 2017Q1
Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes
- 2,162citations
- Q1SCImago
- 2017year
Short summary
Once-weekly exenatide (2 mg) was noninferior to placebo in preventing major adverse cardiovascular events (MACE) in patients with type 2 diabetes, but did not demonstrate superiority. The composite outcome occurred in 11.4% of the exenatide group vs. 12.2% of the placebo group (hazard ratio, 0.91; P=0.06 for superiority) over a median of 3.2 years.
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Key points
- Once-weekly exenatide was noninferior to placebo for major adverse cardiovascular events (MACE) in type 2 diabetes patients.
- Exenatide did not demonstrate superiority over placebo in reducing MACE (hazard ratio 0.91, P=0.06).
- The composite outcome occurred in 11.4% of the exenatide group and 12.2% of the placebo group.
- No significant differences were observed in rates of cardiovascular death, myocardial infarction, stroke, heart failure, acute coronary syndrome, pancreatitis, or specific cancers between groups.
AI-generated from the title and abstract; the full text is not read.
Abstract
BACKGROUND: The cardiovascular effects of adding once-weekly treatment with exenatide to usual care in patients with type 2 diabetes are unknown. METHODS: We randomly assigned patients with type 2 diabetes, with or without previous cardiovascular disease, to receive subcutaneous injections of extended-release exenatide at a dose of 2 mg or matching placebo once weekly. The primary composite outcome was the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The coprimary hypotheses were that exenatide, administered once weekly, would be noninferior to placebo with respect to safety and superior to placebo with respect to efficacy. RESULTS: In all, 14,752 patients (of whom 10,782 [73.1%] had previous cardiovascular disease) were followed for a median of 3.2 years (interquartile range, 2.2 to 4.4). A primary composite outcome event occurred in 839 of 7356 patients (11.4%; 3.7 events per 100 person-years) in the exenatide group and in 905 of 7396 patients (12.2%; 4.0 events per 100 person-years) in the placebo group (hazard ratio, 0.91; 95% confidence interval [CI], 0.83 to 1.00), with the intention-to-treat analysis indicating that exenatide, administered once weekly, was noninferior to placebo with respect to safety (P<0.001 for noninferiority) but was not superior to placebo with respect to efficacy (P=0.06 for superiority). The rates of death from cardiovascular causes, fatal or nonfatal myocardial infarction, fatal or nonfatal stroke, hospitalization for heart failure, and hospitalization for acute coronary syndrome, and the incidence of acute pancreatitis, pancreatic cancer, medullary thyroid carcinoma, and serious adverse events did not differ significantly between the two groups. CONCLUSIONS: Among patients with type 2 diabetes with or without previous cardiovascular disease, the incidence of major adverse cardiovascular events did not differ significantly between patients who received exenatide and those who received placebo. (Funded by Amylin Pharmaceuticals; EXSCEL ClinicalTrials.gov number, NCT01144338 .).
The authors' abstract, as published at the source. New England Journal of Medicine, 2017 · DOI ↗
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Field: Endocrinology, Diabetes and Metabolism
Endocrinology, Diabetes and MetabolismMedicine