The FDA has ordered that the label for fenofibric acid (Trilipix) be changed to indicate that the lipid-lowering drug has not been shown to reduce the risk of heart attack or stroke.…
Data from a substudy of the ACCORD (Action to Control Cardiovascular Risk in Diabetes) trial found no extra benefit in clinical outcomes from a combination of fenofibric acid and simvastatin (Zocor) compared with simvastatin alone, prompting the agency’s move, it said in a Drug Safety Communication.
The FDA had indicated that it was considering changes to the fenofibric acid label last March when the data first became available. Its Endocrinologic and Metabolic Drugs Advisory Committee also reviewed the data at a meeting in May. The panel voted merely to recommend additional study rather than an immediate label change.
The FDA usually follows its advisory committees’ recommendations, but is not obliged to do so — and, in this case, agency officials went with their own judgment, ordering the label change as well as a new study.
According to the new communication, “FDA is requiring the manufacturer of Trilipix to conduct a randomized, double-blind, placebo-controlled clinical trial to test the hypothesis that Trilipix in combination with a statin versus statin alone significantly reduces the incidence of major adverse cardiovascular events in high-risk men and women who are at their low-density lipoprotein (LDL) cholesterol goal on statin therapy, but have residually high triglycerides and low HDL cholesterol.”
The ACCORD data covered about 5,500 patients randomized to the combination or to simvastatin alone. After a median of 4.7 years of follow-up, the addition of fenofibric acid reduced major cardiovascular events by a statistically insignificant 8% (P=0.32).
Events in men were reduced by 18% — which was statistically significant — but, the FDA said, “the clinical significance of this subgroup finding is unclear, as this finding was not observed in a separate large randomized controlled clinical trial of fenofibrate versus placebo.”