Fenofibrate Does Not Halt Atherosclerosis in Patients With Diabetes: Presented at EAS

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Title: Fenofibrate Does Not Halt Atherosclerosis in Patients With Diabetes: Presented at EAS
URL: http://www.pslgroup.com/dg/22060A.htm
Doctor's Guide
April 29, 2008

ISTANBUL, Turkey -- April 29, 2008 -- Fenofibrate has no effect on atherosclerotic progression in patients with type 2 diabetes who are treated for 5 years, although the drug does produce a reduction in levels of low-density lipoprotein cholesterol (LDL-C) compared with placebo.

Jukka Westerbacka, MD, Professor, Department of Medicine, University of Helsinki, Helsinki, Finland, presented the disappointing results of the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Helsinki Substudy here at the 77th Congress of the European Atherosclerosis Society (EAS 2008).

"From previous studies it is known that fibrates decrease cardiovascular events, improve endothelial function, and reduce levels of acute phase proteins," Dr. Westerbacka said in a presentation on April 27. "However, fenofibrate failed to improve the primary outcome of coronary events in the FIELD study, which was the first large, long-term fibrate trial exclusively in type 2 diabetic patients."

The vascular substudy was a prespecified prospective analysis of 238 of the original 270 patients enrolled in the main FIELD study. The aim of the analysis was to determine if treatment with fenofibrate 200 mg/day (n = 113) for 5 years could affect atherosclerotic progression compared with placebo (n = 115).

Two surrogate measures were used to assess the extent of atherosclerosis: (1) carotid intima-media thickness (IMT) was evaluated in 170 patients and (2) the augmentation index (AI), a measure of arterial stiffness that is obtained using pulse wave analysis, was assessed in 151 patients. Measurements were taken at baseline, at 2 years, and after 5 years of treatment.

Dr. Westerbacka noted that almost 30% of patients had a history of cardiovascular disease and had diabetes for 5 to 6 years; the majority were men; the mean age of patients was 62.5 and 61.4 years in the fenofibrate and placebo groups, respectively.

Total cholesterol (TC), LDL-C, and triglyceride (TG) levels were all significantly reduced by fenofibrate therapy compared with placebo. Comparing baseline with treatment end values: TC was 4.9 and 4.9 mmol/L in the placebo group versus 5.1 and 4.3 mmol/L in the fenofibrate group; LDL-C was 3.0 and 3.1 mmol/L with placebo versus 3.3 and 2.7 mmol/L with fenofibrate; TG was 1.7 and 1.6 mmol/L with placebo versus 1.5 and 1.1 mmol/L with fenofibrate. No significant changes were noted in levels of high-density lipoprotein cholesterol.

However, fenofibrate had no effect on the progression of atherosclerosis.

"Surrogate markers of atherosclerosis -- IMT and the augmentation index -- increased similarly in both placebo and fenofibrate groups during the 5-year study," Dr. Westerbacka concluded.

Funding for the FIELD study was provided by Solvay Pharma.

[Presentation title: Effects of 5-Year Fenofibrate Treatment on Arterial Stiffness and Carotid Intima-Media Thickness in Type 2 Diabetes: Field Helsinki Substudy. Abstract: WO6-OR4]

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