FIELD - Fenofibrate Intervention and event lowering in Diabetes
This was presented at AHA2005.
Diabetes mellitus has become a very important risk factor for cardiovascular disease. Diabetes seem to bring about more severe disease and also confers a worse outcome in any category of heart diseaase. It is for these reasons that diabetes has become a major risk factor in CVS disease and is essentially a CAD equivalent.
This is probably why, 5 years ago, Fournier (a French company) planned the FIELD study. They presented some findings at the AHA meeting in Nov 2005 and also published it in the Lancet (Dec 2005).
After following 9795 patients, half on standard therapy and half on fenofibrate and standard therapy for 5.5 years, they found no difference on the primary end-point of non-fatal MI (Myocardial Infarction) and CHD related death.
There was, however, a diference in the secondary endpoint of MACCE (Major Adverse Coronary and Cerebral Event), where there was an 11% reduction after 5.5 years, in the patients on Fenofibrate (lipanthyl).
What this all means is that taking lipanthyl with standard medical therapy in diabetics (including statins), does not lessen the risk of dying, but it certainly reduce the risk of non-fatal MI and also lessens the risk of re-vascularisation.
What is also important is that statins have a profund effect on the results. It is likely that the primary endpoint were not significant because many of the diabetics were already on statins as part of standard medical therapy, and that statins can be safely used in combination with fenofibrate. So patients with diabetics with elevated triglycerides, or even elevated LDL-C or low HDL-C, should be started on fenofibrate. It seems safe and prevents them from non-fatal MI and a need for re-vascularisation.
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