Research findings released today have dashed doctors' hopes that intensive blood pressure and blood fat management could drive down diabetics' higher risks of heart problems.
Results from the highly anticipated Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial proved once again that when it comes to traditional measurements of heart disease risk, lower isn't always better.
Using a blood pressure target of 120 mm Hg rather than the general population standard of 140 did not reduce nonfatal heart attacks, nonfatal strokes or death from cardiovascular causes, reported Dr. William Cushman of the VA Medical Center in Memphis, Tenn.
Likewise, adding the cholesterol-busting drug fenofibrate to standard statin therapy did not reduce the chances of major adverse cardiovascular events, according to Dr. Henry Ginsberg of Columbia University in New York City.
Both studies, part of the complex ACCORD trial, were presented at the American College of Cardiology meeting in Atlanta, Ga. and released simultaneously online in the New England Journal of Medicine.
A third part of this research -- one which examined intensive lowering of blood sugar to see if this had a positive effect -- was prematurely halted in 2008 because it turned out that patients receiving this approach actually had an increased, instead of decreased, risk of death.
The new lipid and blood pressure results round out the negative portrait of aggressive risk factor management in diabetes patients, commented Dr. Brian O'Murchu of Temple University in Philadelphia, a co-chair of the ACC's annual scientific sessions planning committee.
In an interview with MedPage Today, O'Murchu echoed the concern voiced by diabetes experts at the initial presentation of the blood glucose arm results: Pushing too hard may not help, and it may actually hurt in some cases.
As for the newly released findings, the lipid arm of ACCORD included 5,518 patients with high risk of heart problems because of cardiovascular disease or at least two risk factors. LDL, or bad, cholesterol levels had to be between 60 and 180 mg/dL; HDL, or good cholesterol, levels had to be under 50 mg/dL or 55 mg/dL for women and blacks; and triglycerides had to be under 750 mg/dL if the patients were not on any therapy, or 400 mg/dL otherwise.
Patients either received fenofibrate or a placebo in addition to statins.
What the researchers found was that lipid and triglyceride levels responded as expected. Despite this, however, the patients appeared to receive no benefit when it came to major heart problems such as heart failure, stroke and nonfatal heart attacks.
Meanwhile, Cushman's blood pressure portion of ACCORD compared a strategy of keeping systolic blood pressure under 120 mm Hg to one of under 140 mm Hg in 4,733 diabetes patients with high risk of cardiovascular events because of clinical or subclinical heart disease or at least two risk factors. In this trial, treatment effectively lowered blood pressure. But again, there was no impact on aspects of patient health including death risk, death related to heart problems and nonfatal heart attacks.
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."