Abbott’s blockbuster cholesterol drug, Trilipix (fenofibrate), which is taken in combination with a statin was found to be no better at reducing heart attack risk than taking the statin alone, in a trial involving diabetic patients. An FDA Advisory Committee will meet this week to decide whether the FDA should alter the drug’s key indication.

Trilipix lowers LDL (low-density lipoprotein) as well as VLDL (very low density lipoprotein), and increases HDL (high-density lipoprotein). It also reduces triglyceride levels. The drug is a fibrate.

It is approved by the FDA to be used in combination with statins.

A government-funded study involving 5,000 patients with diabetes divided participants into two groups. One group received both Trilipix plus a statin, while those in the other group were given just the statin. The researchers reported that heart attack rates were the same in both groups – adding the Trilipix to the medication mix did not appear to reduce heart attack risk.

The FDA Advisory Committee has been asked by the FDA to review data on Trilipix and decide whether the labeling should be updated and whether its approval for use with statins should be rescinded.

The Advisory Committee can only recommend, whatever it says is not binding. However, the FDA usually goes along with its advice.

The study also revealed that females who took the combination Trilipix plus a statin had a higher heart attack risk than female patients on statins alone. The FDA has asked the Committee to discuss those data.

May 19, 2011: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement

Abbott Laboratories points out that two-thirds of the participating patients in the study would not have been eligible for Trilipix according to prescribing guidelines.

Written by Christian Nordqvist