The FINANCIAL — Solvay’s and Abbott's TriLipix TM (fenofibric acid delayed-release capsules) was approved by the U.S. Food and Drug Administration (FDA) for use along with diet to help lower triglycerides and LDL cholesterol, and to raise HDL cholesterol in patients with lipid problems.
"TriLipixTM 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," Solvay reported.
"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 Michael Davidson, M.D., clinical professor and director of Preventive Cardiology, University of Chicago Pritzker School of Medicine. "The approval of TriLipixTM 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."
TriLipixTM was studied in 2,698 patients with mixed dyslipidemia, a disorder of all three key lipids affecting millions of American adults. In the TriLipixTM 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 TriLipixTM 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 Panel (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.
TriLipixTM will be copromoted in the U.S. by Solvay Pharmaceuticals Inc and Abbott.
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