Tricor disappoints in diabetes trial

Nov 15 2005

Researchers say the results of a large trial of a drug to lower triglycerides failed in its primary goal of significantly reducing heart attacks and coronary deaths among patients with type II diabetes.

But there was some good news in that patients taking Tricor, one of Abbott's best-selling medicines, fared better than those taking placebos on a number of secondary measures, including a reduction in the need for procedures to clear clogged arteries and for laser treatments of eye disease.

Dr. Anthony Keech, an associate professor of medicine at the University of Sydney in Australia, the trial's lead researcher, says the results of the trial were mixed.

The most common form of diabetes, is type II diabetes which typically develops in adulthood, and is closely linked to obesity; it has become a growing problem around the world.

The drug Tricor, whose chemical name is fenofibrate, was tested in a five-year study involving nearly 10,000 male and female diabetics in Australia, New Zealand and Finland.

More than three quarters of the patients had no prior history of heart disease.

It was found by the end of the trial, that those taking Tricor had an 11 percent smaller combined incidence of heart attack or coronary death than those taking placebos.

But the reduction, the main goal of the trial, was not considered statistically significant.

Dr. Keech says that during the study, patients in both groups were allowed to begin the use of statins, the popular class of drugs, such Pfizer's Lipitor, that work by cutting "bad" LDL cholesterol.

He says the results of the trial were skewed against Tricor, because 17 percent of those in the placebo group began taking a statin, compared with only 8 percent of those in the Tricor group.

It appeared that those taking Tricor had a slightly higher increased overall risk of death, but it was statistically insignificant.

Apparently had similar numbers of patients in both groups taken heart-protective statins, Tricor would have met its primary goal and cut the combined incidence of heart attack and coronary death by 16 percent to 20 percent, says Keech.

As those taking Tricor had a 24 percent reduced risk of non-fatal heart attacks and a 21 percent reduction in the need for coronary angioplasties or bypass surgeries to clear clogged arteries, the secondary goals of the study were met.

The favorable benefits of Tricor, which had U.S. sales last year of $779 million, were seen mostly among patients with no prior history of heart disease, where the drug cut the risk of total adverse cardiovascular events by 19 percent.

Dr. keech says that although Tricor missed its primary goal, clearly its benefits may be worthwhile for patients on statins or those unable to take statins.

The trial results were presented at the American Heart Association's annual scientific meeting.