GRACE: Insulin Glargine and Fatty Acids Impact Carotid Intima Media Thickness in High-Risk Diabetes

Insulin glargine may modestly reduce carotid intima media thickness (CIMT) progression in high-risk patients with cardiovascular (CV) disease or CV risk factors and dysglycemia, but daily omega-3 (n-3) fatty acid supplements have no effect on CIMT progression, according to results from the Glucose Reduction and Atherosclerosis Continuing Evaluation (GRACE) trial, unveiled on Aug. 27 at the ESC Congress 2012 in Munich. GRACE is a substudy of the Outcome Reduction with an Initial Glargine Intervention (ORIGIN) trial that was published in June 2012.


Results from the GRACE study found that compared to standard care, insulin glargine did not significantly reduce the primary CIMT outcome, although the difference was not statistically significant (difference =0.0030 ± 0.0021 mm/year; p=0.145). However, secondary CIMT outcomes were significantly reduced (differences of 0.0033 ± 0.0017  mm/year; p=0.049 and 0.0045 ± 0.0021 mm/year; p=0.032, respectively). Secondary outcomes included the annualized change in Maximum CIMT for the Common Carotid (4 segments) and the annualized change in Maximum CIMT for the Common Carotid and Bifurcation  (8 segments). According to study authors, these findings raise the possibility that longer-term treatment might result in reductions in CV events.


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In terms of n-3 fatty acid supplements, data from the study showed they had a neutral effect on risk factor levels, carotid atherosclerosis and on clinical events. However, the authors highlight that it is unclear if these findings are unique to the study population and the n-3 fatty acid supplements dose used. They note that several clinical endpoint trials are still ongoing. Overall, the main ORIGIN trial and the GRACE-ORIGIN substudy do not support the use of N-3 fatty acid supplements in high-risk people with dysglycemia.


The 2-by-2 factorial design study looked at 1,184 patients averaging 63 years of age who had CV disease and/or CV risk factors and type 2 diabetes, impaired fasting glucose or impaired glucose tolerance. Patients either received insulin glargine and standard care or standard glycemic care alone and double-blind therapy with fatty acid supplements or placebo.

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