Abbott Receives FDA Approval for Trilplix (fenofibric acid), First and Only Fibrate Indicated for Use in Combination With a Statin for Cholesterol Management

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FDA Approves Trilplix

Abbott Receives FDA Approval for Trilplix (fenofibric acid), First and Only Fibrate Indicated for Use in Combination With a Statin for Cholesterol Management

New Therapy in Combination with a Statin Helped Patients Improve HDL and LDLCholesterol and Triglycerides in Clinical Studies

ABBOTT PARK, Ill., December 15, 2008 /PRNewswire-FirstCall/ -- Today, the U.S. Food and Drug Administration (FDA) approved Abbott's Trilipix (fenofibric acid) delayed-release capsules for use along with diet to help lower triglycerides and LDL cholesterol, and to raise HDL cholesterol in patients with lipid problems. Trilipix is the first and only fibrate to be approved for use in combination with a statin. In certain patients, treatment guidelines recommend the combination of a fibrate with a statin to further improve lipid levels. Trilipix has not been shown to prevent heart disease or heart attack.

"Only 35 percent of patients with lipid problems are currently being treated with lipid therapies and many are not reaching treatment targets for all three key lipids," said son, M.D., clinical professor and director of Preventive Cardiology, Pritzker School of Medicine. "The approval of Trilipix 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."

Trilipix was studied in 2,698 patients with mixed dyslipidemia, a disorder of all three key lipids affecting millions of American adults. In the Tri

lipix studies, mixed dyslipidemia was characterized by elevated LDL (bad cholesterol) and triglycerides (a type of fat found in the blood) and low HDL (good cholesterol). These studies demonstrated that Trilipix used in combination with the most commonly prescribed statins helped patients manage all three key lipids better than the corresponding therapies alone.

Treatment guidelines endorsed by the National Cholesterol Education Program (NCEP), the American College of Cardiology and the American Heart Association have called for more aggressive management of lipids, including a lower LDL goal for many patients, as well as more aggressive management of HDL and triglycerides.

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