ATLANTA -- The FDA 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.
The study, known as ACCORD, investigated the addition of fenofibrate to statin therapy. It was this add-on therapy that appears to have triggered the FDA review. The addition of fenofibrate did not reduce cardiovascular events, the study found, although there was a non-significant trend toward a benefit in a subset of patients.
Asked about the timing of the announcement, an FDA spokesperson said the agency was attempting to be more proactive.
The spokesperson said the agency planned to include a review of the labeling and indications for fenofibric acid (Trilipix). It should, however, be noted that the trial used fenofibrate (TriCor).
Both Trilipix and TriCor are marketed by Abbott, and Trilipix is "the active metabolite of TriCor," according to Marshall Elam, MD, PhD, of the Memphis VA Medical Center.
Elam, who was involved in the design of the lipid treatment arm of ACCORD told 鶹ý, 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.
The ACCORD findings were reported today at a late-breaking clinical trials session at the American College of Cardiology meeting and were simultaneously published online in New England Journal of Medicine.
In a statement released after the ACCORD results were reported, but before the FDA announced its 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.
While the primary endpoint was not met, within the pre-specified subgroup of patients with high-triglycerides and low-HDL, the addition of fenofibrate to simvastatin was associated with a 31% lower rate of heart attack, stroke and cardiovascular death than simvastatin alone, as noted in the investigator presentation.
The study authors concluded that the subgroup results support the view that the addition of fenofibrate to a statin may benefit patients with type 2 diabetes who have substantial dyslipidemia."
Abbot has not yet responded to a request for a comment about the FDA announcement.