"Clearly, we have mixed results," says researcher Anthony Keech, MD, an associate professor of medicine at the University of Sydney in Australia.
Nearly 21 million Americans have diabetes, mostly type 2 diabetes. About two-thirds of people with diabetes die from cardiovascular disease, which has sparked a search for new ways to prevent heart disease and strokes among these patients.
Statins and Tricor
The new study, presented at the annual meeting of the American Heart Association, included 9,795 men and women with type 2 diabetes. About half the people were given Tricor and the rest were given a placebo (fake pill).
After the study had started, another large trial (the Heart Protection Study) showed that the cholesterol-lowering statin drug Zocor slashed the risk of heart attack and strokes in people with diabetes -- even if their cholesterol levels were normal. As a result, people in both groups of the TriCor study were allowed to begin taking statins to lower LDL cholesterol at their doctor's discretion.
Five years later, people taking TriCor were 11% less likely to have had a heart attack or died due to heart disease, compared with those taking placebo. But the reduction -- the main goal of the trial -- could have been due to chance, Keech says.
The results were biased against TriCor, he says, because 17% of those in the placebo group were taking a statin vs. only 8% of those in the TriCor group. "This imbalance may have masked a 17% to 20% reduction in heart attack and coronary deaths," Keech says.
TriCor Reduces Needed for Angioplasty, Eye Surgery
On almost every other score, people on Tricor fared better, he says.
TriCor was associated with a 24% reduction in nonfatal heart attacks, a 21% reduction in the need for angioplasty to open up clogged heart arteries or bypass surgery, and a 30% reduction in the need for laser surgery for diabetes-related eye problems.
The people who seemed to benefit the most from the triglyceride-lowering therapy were those with no prior history of heart disease, he says. In this group, which included about three-fourths of the participants, the drug cut the risk of heart attacks and heart deaths by 19%.
The bottom line, Keech tells WebMD, is that "while you would not want to replace a statin with [TriCor], one could argue that there is considerable room for considering [TriCor] on top of a statin in people with type 2 diabetes."
TriCor should not be taken by those with serious liver, kidney, or gallbladder disease, according to Abbott, the manufacturer of Tricor. Adverse reactions may include muscle pain, elevated liver enzymes, abdominal pain, nausea, headache, and back pain. Abbott also provides warnings regarding the combined use of TriCor and statins and TriCor with certain other medications.
Further Studies Necessary
Lawrence Appel, MD, agrees that the higher statin use among the placebo group could have skewed the results. Appel is a professor of medicine at Johns Hopkins University in Baltimore.
"It could be that TriCor has benefit," he tells WebMD. "But I'd like to see more studies."
Timothy Gardner, MD, agrees. Gardner is chairman of the committee that selected the studies that were highlighted at the heart meeting. He is also a heart surgeon at Christiana Care Health Services in Wilmington, Del.
"The hope was that TriCor would have a beneficial effect on heart attack and coronary deaths," Gardner says. "It did not, but it shows promise for a number of secondary factors such as diabetic eye disease. That's a big issue."
Nevertheless, both Gardner and Appel say they would not begin giving TriCor to all patients with diabetes based on this trial alone. "But I will be looking for other effective ways to lower their cholesterol," Gardner says.