Combination therapy with simvastatin and fenofibrate may offer advantages over the use of either agent alone in diabetic patients with mixed dyslipidemia. As lead investigator Dr. Joseph B. Muhlestein stated that, "much of the cardiovascular risk associated with diabetes may stem from the associated abnormal ‘diabetic’ lipid profile. This profile, which is characterized by a combination of abnormal lipid parameters, cannot often be rectified by just one drug."
To investigate the possible benefits of combination therapy, Dr. Muhlestein of LDS Hospital, Salt Lake City, Utah and colleagues randomized 300 patients with type 2 diabetes, mixed dyslipidemia and no history of heart disease, to daily treatment with simvastatin 20 mg, fenofibrate 160 mg, or to both of these doses of the agents.
At 12 weeks, median levels of high-sensitivity C-reactive protein had fallen by 14.6%, but the effect did not differ across treatment groups. This was also the case for the 16.8% drop seen in median lipoprotein-associated phospholipidase A2.
Reductions in both of these inflammatory biomarkers were greatest in patients with the highest baseline drug levels.
However, the researchers found that combination therapy was superior to fenofibrate alone in reducing total cholesterol, LDL- C, and non-HDL-C. Compared to simvastatin, it was superior in reducing triglyceride levels.
"Like in patients with high blood pressure, a multi-drug therapy approach may be necessary. Dr. Muhlestein concluded. This study shows that the combination of a statin and a fibrate is safe and more effective than monotherapy in improving the atherogenic lipid profile of diabetic patients."
J Am Coll Cardiol 2006;48:396-401.
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