CardioExchange Archive

A large new study has found no evidence of cardiovascular (CV) benefits for either basal insulin or omega-3 fatty acids in a population of people with diabetes or at risk for diabetes. Results of the ORIGIN (Outcome Reduction with Initial Glargine Intervention) study were presented today at the annual meeting of the American Diabetes Association and published simultaneously in the New England Journal of Medicine.

In a 2 x 2 factorial design, more than 12,500 patients with impaired fasting glucose, impaired glucose tolerance, or diabetes were randomized to either insulin glargine or standard care and to either omega-3 fatty acids or placebo. After a median followup of 6.2 years, there were no significant differences in outcomes in either of the randomizations.

Insulin glargine versus standard care:

• Nonfatal MI, nonfatal stroke, or CV death: 16.6% versus 16.1% (hazard ratio, 1.02, CI 0.94 – 1.11, p = 0.63)
• Nonfatal MI, nonfatal stroke, CV death, revascularization or HF hospitalization: 28.6% versus 27.5%, HR 1.04, CI 0.97 – 1.11, p = 0.27)

People taking insulin glargine were more likely to gain weight and develop hypoglycemia, but had better glucose control than people receiving standard care. Patients without diabetes at baseline receiving insulin were less likely to progress to diabetes. There was no difference in cancer between the two groups.

The ORIGIN investigators noted that the glycemic benefit of insulin glargine might have an impact on microvascular or other outcomes but concluded that the trial does “not support changing standard therapies for early dysglycemia.”

Omega-3 fatty acids versus placebo:

• CV death (primary endpoint): 9.1% versus 9.3% (HR 0.98, CI 0.87 – 1.10, p = 0.72)
• Major vascular events: 16.5% versus 16.3% (HR 1.01,CI 0.93 – 1.10, p = 0.81)
• Death from any cause: 15.1% versus 15.4% (HR 0.98, CI 0.89 – 1.07, p = 0.63)
• Death from arrhythmia: 4.6% versus 4.1% (HR 1.10, CI 0.93 – 1.30, p = 0.26)

The authors cautioned that their results “may not be relevant to dietary recommendations to consume more fish, because dietary change not only increases the intake of foods containing n–3 fatty acids but is also associated with a reduction in the consumption of foods such as red meats, which may be harmful.”