Patients with type 2 diabetes treated with once-weekly exenatide may not have a significant difference in major cardiovascular events compared with those treated with placebo, according to a study by the New England Journal of Medicine.
Researchers identified 14,752 participants who were randomly assigned 1:1 to receive either once-weekly subcutaneous injections of extended-release exenatide (n=7356) or placebo (n=7396). This study is a prospective, double-blinded trial that took place at 687 sites in 35 countries (ClinicalTrials.gov identifier: NCT01144338), with participants followed for an average of 3.2 years.
The primary outcome observed in this study was the first occurrence of death as a result of a cardiovascular cause, nonfatal myocardial infarction, or nonfatal stroke. It was hypothesized that exenatide would be noninferior with regard to safety, and superior with regard to efficacy, when compared with placebo.
Study results showed primary outcome events occurred in 839 of 7356 patients receiving once-weekly exenatide, and in 905 of 7396 receiving placebo (hazard ratio, 0.91; 95% CI, 0.83-1.00). The intention-to-treat analysis concluded that once-weekly exenatide was noninferior to placebo with regard to safety (P <.001), and was not superior with regard to efficacy compared with placebo (P =.06).
Researchers concluded that the incidence of major cardiovascular events among those treated with once-weekly exenatide and placebo did not differ significantly. Therefore, clinicians may note that exenatide is considered a safe drug to use in this patent population, but may not be the most effective treatment option, as it did not demonstrate a higher efficacy when compared with placebo.
This study was funded by Amylin Pharmaceuticals (San Diego, CA).
Holman RR, Bethel MA, Mentz RJ, et al; EXSCEL Study Group. Effects of once-weekly exenatide on cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2017;377:1228-1239.