ABBOTT PARK, Ill., May 19, 2011 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today held an Endocrinologic and Metabolic Drugs Advisory Committeeto review the results of the ACCORD Lipid study as they relate to the use of fenofibric acid (sold as Trilipix® in the United States) in combination with a statin in patients with mixed dyslipidemia and at high risk of
"Abbott appreciates the Committee's recognition that the totality of data, including ACCORD Lipid, supports retaining the co-administration indication for Trilipix in appropriate patients," said Eugene Sun, M.D, vice president, Global Pharmaceutical Clinical Development, Abbott. "We also appreciate the request for more clinical data and look forward to further discussions with the FDA."
The National Cholesterol Education Program (NCEP) treatment guidelines recommend consideration of the use of a fibrate with a statin in patients with triglycerides at or above 200 mg/dL who are at LDL cholesterol goal, but not at non-HDL cholesterol goal. Two thirds of patients in the ACCORD Lipid study would not qualify for treatment with fibrates under current guidelines. In this study, the median triglyceride level was 162 mg/dL.
The recommendation of the Endocrinologic and Metabolic Drugs Advisory Committee will be considered by the FDA in its decision-making process on fenofibric acid.
Trilipix (fenofibric acid) delayed-release capsules is a prescription medicine that can be used along with diet to lower triglycerides and LDL (bad) cholesterol, and increase HDL (good) cholesterol. Trilipix can also be used along with diet to lower triglycerides
and increase HDL cholesterol in people who are at high risk of heart disease and are taking a statin medicine to control their LDL cholesterol. Trilipix has not been shown to prevent heart attacks or stroke more than a statin alone.
Important Safety Information
For more information, patients should talk with their health care provider. Full prescribing information for Trilipix (fenofibric acid) is available at http://www.rxabbott.com/pdf/trilipix_pi.pdf.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and markets its products in more than 130 countries.
Abbott information is available on the company's website at www.abbott.com.
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