FDA OKs New Cholesterol Drug Trilipix

Trilipix Is the First Fibrate Approved for Use With a Statin; Diet Still Counts

By Miranda Hitti
WebMD Health News

Reviewed By Louise Chang, MD

Dec. 15, 2008 -- The FDA has approved a new drug called Triliplix for use along with diet to lower LDL ("bad") cholesterol, lower triglycerides, and raise HDL ("good") cholesterol.

Trilipix (delayed-release capsules) belongs to a class of drugs called fibrates. That's not a new class of drugs; other fibrates include gemfibrozil (sold generically and under the brand name Lopid), fenofibrate (sold under the brand names Antara, Lofibra, Tricor, and Triglide), and clofibrate (sold under the brand name Atromid-S).

Trilipix is the first fibrate to be specifically approved for use along with a statin. Other fibrates are often prescribed with statins, but that's technically an off-label use of those drugs. Patients who take Trilipix with a statin must either have coronary heart disease or a coronary heart disease risk equivalent and who are on optimal statin therapy to achieve their LDL cholesterol goal, according to the FDA.

According to a news release from Abbott, the drug company that makes Trilipix, the FDA approved Trilipix based on clinical trials that included nearly 2,700 patients with high levels of LDL cholesterol and triglycerides and low HDL levels. Some of the patients took cholesterol-lowering drugs called statins; others took statins and Trilipix. LDL levels dropped for all patients, but improvement in HDL and triglyceride levels was greater for patients taking statins and Trilipix.

Abbott notes that Trilipix has not been shown to prevent heart disease or heart attack.

Abbott and the drug company  AstraZeneca, which makes the statin Crestor, are working on making a combination pill that combines Trilipix and Crestor. The companies plan to submit that drug application to the FDA in 2009, according to Abbott.

SOURCES: FDA. News release, Abbott.

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