GRACE: Use of insulin glargine and fatty acids to reduce atherosclerosis progression.

Presentation Summary: There is a clear association between hyperglycemia and the development of atherosclerosis. The GRACE sub trial, (from ORIGIN study), evaluated the administration of omega-3 and insulin glargine and their benefits in reducing atherosclerosis progression. Conducted at 32 centers in 7 countries, this study included 1,092 individuals with hyperglycemia and increased risk of cardiovascular events. Using a randomized 2×2 factorial design, four treatment groups were formed: insulin glargine + placebo, insulin glargine + omega-3, omega-3 + regular insulin and placebo + regular insulin. The primary endpoint was myointimal thickness change at 6 years of follow up.

Treatment adherence was 86% for patients treated with insulin glargine and 91% for omega-3. 90.5% of patients had a diagnosis of diabetes mellitus. At the end of 6 years of follow up, all treatment groups tolerated and had similar changes in carotid myointimal thickness. In turn, insulin glargine reduced levels of triglycerides, fasting glucose and glycosylated hemoglobin, whereas the administration of omega-3 did not alter the cardiovascular risk factors.

Review: The ORIGIN-GRACE study is the largest randomized study conducted to date which evaluates the impact of insulin glargine and omega-3 in atherosclerosis progression. Both strategies were shown to be safe and well tolerated, although no benefits were observed in terms of progression of vascular disease.

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E. Lonn
2012-08-26

Original title: GRACE: Effects of Insulin Glargin and of Polyunsaturated Fatty Acids on Carotid Intima Media Thickness in High-Risk Diabetes.

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