The U.S. Food and Drug Administration said it will conduct a full review of findings from a study which concluded that neither aggressive lipid-lowering therapy nor tight blood pressure control reduced cardiovascular events in persons with diabetes.
An FDA spokesperson said the agency planned to include a review of the labeling and indications for fenofibric acid (Trilipix) -- even though the trial used fenobrate (TriCor). Asked about the timing of the announcement, the spokesperson said the FDA was attempting to be more proactive.
Both Trilipix and TriCor are marketed by Abbott, and Trilipix is "the active metabolite of TriCor," according to Dr. Marshall Elam of the Memphis VA Medical Center.
Elam, who was involved in the design of the lipid treatment arm of ACCORD told MedPage Today, that "neither TriCor nor Trilipix has a label indication for cardiovascular disease."
The FDA said it would release more details concerning the planned review tomorrow.
In a statement released after the ACCORD results were reported, but before the FDA said it would conduct a review of the ACCORD findings, Abbott said the data from the ACCORD Lipid trial, "supports the appropriate patient type and current treatment guidelines for fibrates. The top-line results of the study were widely expected, given that two-thirds of patients in the trial would not be recommended for fibrate therapy under current guidelines."