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Dec 16, 2008

Abbott Gets FDA Nod for Fibrate to Be Used Along with a Statin

  • FDA has sanctioned Abbott's Trilipix™ 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. It is the first and only fibrate to be approved for use in combination with a statin, according to the firm.

    The FDA's approval of Trilipix was based on studies that showed that combination therapy improved HDL and triglycerides compared to statin therapy alone and improved LDL compared to Trilipix alone, Abbott reports. The firm conducted three randomized, multicenter, double-blind, controlled, 12-week Phase III studies, totaling 2,698 patients with mixed dyslipidemia. Each evaluated Trilipix in combination with either rosuvastatin, atorvastatin, or simvastatin. Patients included in the studies had multiple lipid problems with an LDL greater than 130 mg/dL, triglycerides greater than 150 mg/dL, and HDL less than 40 mg/dL for men and less than 50 mg/dL for women.

    “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,” according to Michael Davidson, M.D., clinical professor and director of preventive cardiology, University of Chicago Pritzker School of Medicine.



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