Federal regulators approved Abbott’s TripLipix for stand-alone treatment and combo use to lower LDL (bad) cholesterol, lower triglycerides, and raise HDL (good) cholesterol in patients with lipid problems, according to a news release from the drugmaker.

The drug belongs to a class of drugs called fibrates, which also includes gemfibrozil, sold under the brand name Lopid, fenofibrate (known as Antara, Lofibra, Tricor and Triglide). TriLipix is the first cholesterol medicine in its class to be approved for use with statins, which are the first-line treatment and which dominate the $15 billion global market for cholesterol-fighting drugs. Lowering cholesterol and triglyceride levels are thought to protect against heart disease, though Abbott’s drug hasn’t been shown to prevent heart disease or heart attack.

Abbott also said it plans to seek U.S. approval in 2009 for a fixed-dose pill that combines TriLipix with AstraZeneca PLC’s Crestor. The two companies recently began co-marketing Crestor. Studies conducted by the company have shown that the combination of TriLipix with statins has improved the level of HDL and LDL cholesterol and of triglycerides.

“The approval of [fenofibric acid] 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,” said Michael Davidson, MD, Preventive Cardiology, University of Chicago Pritzker School of Medicine, Chicago, Illinois.

Statins are prescribed to reduce LDL cholesterol and raise HDL levels, but they have no major effect on triglycerides. According to Abbott, 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. The clinical trials showed an improvement in HDL and triglycerides levels in patients taking a combination of statins with TriLipix.