March 14, 2010
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Lipid improvements attained up to two years with fenofibric acid plus rosuvastatin

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American College of Cardiology 59th Annual Scientific Sessions

ATLANTA – Fenofibric acid in combination with rosuvastatin daily therapy increased HDL and decreased LDL and triglyceride levels, and was associated with no adverse event reports in patients with mixed dyslipidemia, new study findings revealed.

The two-year results of a phase-3, multicenter, open-label study were presented in a poster presentation today.

Researchers assessed the long-term efficacy and safety of daily fenofibric acid 135 mg (Trilipix, Abbott) in combination with rosuvastatin 20 mg. The study included 174 patients with mixed dyslipidemia aged 18 years and older (94% white; 55.7% men). The researchers randomly assigned patients to fenofibric acid, rosuvastatin or a combination of both for 12 weeks, followed by open-label treatment with fenofibric acid 135 mg plus rosuvastatin 20 mg for two years.

At baseline, lipid levels were consistent with mixed dyslipidemia. Improvements were observed across mean lipid levels at weeks 64 (n=174) and 116 (n=161).

Patients assigned to fenofibric acid plus rosuvastatin experienced an increase in HDL levels from 38.4 mg/dL at baseline to 45 mg/dL at week 116. Further, LDL levels decreased from 151.8 mg/dL at baseline to 87 mg/dL and triglycerides decreased from 289.2 mg/dL at baseline to 137.5 mg/dL. Total cholesterol also decreased, from 259.6 mg/dL at baseline to 158.1 mg/dL at week 116.

The researchers observed minor mean changes from baseline to week 116 in the safety laboratory values.

Adverse events tended to occur early in the treatment course and the researchers reported no new or unexpected muscle, hepatic or renal effects.

“Patients with high triglycerides, low HDL and high LDL achieved good control with no cumulative adverse events for up to two-years of treatment,” Peter H. Jones MD, associate professor of atherosclerosis and vascular medicine at Baylor College of Medicine in Houston, told Endocrine Today. “Patients such as the subgroup included in the ACCORD Lipid trial with mixed dyslipidemia may be the ones who benefit most from this combination treatment.” – by Jennifer Southall

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