The questions about Abbott Laboratories' cholesterol drug TriLipix aren't going away. The FDA issued a safety communication saying the drug may not lower a patient's risk of heart attack or stroke. And the agency says it's requiring Abbott ($ABT) to conduct a new study to test TriLipix, a fibrate drug, in high-risk patients using statin meds.
The agency's move comes more than a year after a study known as ACCORD found that adding Trilipix's predecessor TriCor to statin therapy provided no additional reduction in heart attacks and other cardiac problems in patients with diabetes. FDA reviewed the data from that study, which compared statin therapy with a statin-plus-TriCor regimen, and decided to let healthcare professionals know that Trilipix "may not lower a patient's risk of having a heart attack or stroke."
The agency now wants to test Trilipix itself against statin monotherapy in a broader population. The agency asked Abbott to set up a randomized, double-blind, placebo-controlled trial to test whether adding fenofibrate to statin therapy would cut cardiovascular events in high-risk patients who've reached their LDL goal on statin therapy, but still have high triglycerides and low HDL.
- read the FDA statement
- see the coverage in Forbes
- get more from Reuters