NEW YORK -- December 15, 2008 -- The US Food and Drug Administration (FDA) has approved fenofibric acid (TriLipix) delayed-release capsules for use along with diet to help lower triglycerides and low-density lipoprotein (LDL) cholesterol, and to raise high-density lipoprotein (HDL) cholesterol in patients with lipid problems. Fenofibric acid can be used alone or in combination with a statin.
"Only 35% of patients with lipid problems are currently being treated with lipid therapies and many are not reaching treatment targets for all 3 key lipids," said Michael Davidson, MD, Preventive Cardiology, University of Chicago Pritzker School of Medicine, Chicago, Illinois.
"The approval of [fenofibric acid] is good news for patients because now there is a new treatment option that can be used alone or in combination with a statin to help address lipid problems."
The approval is based on the results from a trial evaluating the efficacy and safety of a fibrate in combination with various statins. The efficacy and safety of fenofibric acid in combination with rosuvastatin, atorvastatin, and simvastatin was evaluated in 3 randomised, multicentre, double-blind, controlled, 12-week, phase 3 studies, totalling 2,698 patients with mixed dyslipidaemia.
Patients included in the studies had multiple lipid problems, with an LDL >=130 mg/dL, triglycerides >=150 mg/dL, and HDL <40 mg/dL for men and <50 mg/dL for women. A total of 1,911 patients who completed one of the 12-week studies subsequently enrolled in a 52-week long-term, open-label extension study.
The phase 3 combination studies all met their primary endpoints. Combination therapy significantly improved HDL and triglycerides compared with statin therapy alone, and significantly improved LDL compared with fenofibric acid alone. All of the combinations and the statins had clinically meaningful reductions in LDL.
The most common side effects included headache, heartburn, nausea, muscle aches, and increases in muscle or liver enzymes.
SOURCE: Abbott
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