MONDAY, Nov. 14, 2005 (HealthDay News) -- A standard cholesterol drug appears able to reduce the incidence of heart attacks and coronary interventions such as bypass surgery in people with type 2 diabetes.
The drug, TriCor (fenofibrate), however, did not reduce coronary death among a large sample of patients enrolled from 63 sites in three countries.
"This trial shows mixed results on the effects on fenofibrate," principal investigator Dr. Anthony Keech, a professor of medicine at the University of Sydney in Australia, said Monday during the American Heart Association's annual meeting in Dallas. "Benefits were greatest in the primary prevention population. We saw a significant reduction in nonfatal, but not fatal, events associated with treatment."
Dr. Lawrence Appel, a professor of medicine at Johns Hopkins Medical School and vice chairman of the American Heart Association's nutrition committee, agreed the trial results were mixed. "Diabetics often take a lot of medications. This could be at the least the sixth or the 10th. We need more convincing evidence."
The researchers did see pronounced reductions in microvascular complications such as diabetic eye disease and amputations.
Overall, there may be a role for TriCor as a supplement to statins, Keech said. The findings were also published in the Nov. 14 online issue of The Lancet.
"These results would not argue with replacing statin therapy because the results of the statin trials are very clear. But they would argue that there's considerable room for considering the addition of fenofibrate in patients who are already on statins, not only for macrovascular benefits, but also for microvascular benefits," Keech said.
"There are nearly 300 million people with diabetes in the world, and around 30 million will have a vascular event in the next two years," Keech noted. "This drug could help avoid something like 2 million vascular events a year."
People with type 2 diabetes are at a much higher risk for developing cardiovascular disease. According to the American Diabetes Association, two out of three people with diabetes die from heart disease and stroke.
While the role of statins is well-established in patients with diabetes, there have been few studies on fenofibrate, Keech said. Fenofibrate is marketed by Abbott as TriCor in the United States.
The present trial is the largest study to look at any treatment to prevent cardiovascular disease in people with diabetes.
This study involved 9,975 patients with type 2 diabetes in Australia, New Zealand and Finland. More than three quarters (78 percent) of the participants had no prior cardiovascular disease, while the remainder had at least one manifestation of cardiovascular disease.
All participants were randomly chosen to receive either fenofibrate or a placebo, with an average follow-up of five years.
Participants taking the drug had 11 percent fewer major coronary events (heart attack, coronary death) than those taking a placebo. However, this difference was not considered statistically significant. The reduction was primarily due to decreases in nonfatal heart attack (24 percent reduction) and in the need for bypass surgery (21 percent reduction).
Most of the benefits were seen in the primary prevention group (those patients who did not yet have cardiovascular disease). Here, fenofibrate reduced the risk of total cardiovascular events by 19 percent.
Physicians involved in the study were allowed to prescribe statins to participants if the need arose. More patients in the placebo group (17 percent) were prescribed statins than in the fenofibrate group (8 percent), something which could indicate an added, masked benefit in the treatment arm, Keech said.
Perhaps even more startling were the microvascular benefits. As their disease progresses, people with diabetes experience a deterioration in their blood vessels which, in addition to such problems as heart attacks, can result in eye damage, kidney failure and amputation.
In this trial, people taking fenofibrate had a 30 percent reduction in the need for laser treatment for diabetic eye disease, Keech said.
There was also a reduction in the progression of urinary albumin, which is a marker of kidney disease; a reduction of 30 percent in the need for amputation; and a reduction of 18 percent for angina pectoris (chest pain).
"Retinopathy and albumin are big-league issues for diabetics," Appel said. "There might be a more unique benefit."
Only 9 percent of participants stopped taking fenofibrate, about the same rate as people discontinuing the placebo.
In other encouraging news, researchers reported benefits for hospitalized heart-failure patients from an experimental drug called levosimendan. The drug is available in Europe but not yet in the United States, said study author Dr. Milton Packer, director of the Center for Biostatistics and Clinical Science at the University of Texas Southwestern Medical Center in Dallas.
There are 5 million people in the United States with heart failure, of whom at least 1 million are hospitalized each year. New drugs to treat these patients have been slow in coming, Packer said. Levosimendan works by a novel mechanism: It makes proteins in the cells more sensitive to calcium. Mortality data for the drug will be presented later this week.
More information
For more on complications from type 2 diabetes, visit the American Diabetes Association.
