Intermountain Press Release

Salt Lake City—Note: Embargoed by the American College of Cardiology

A new study by cardiac researchers at LDS Hospital is good news for hundreds of thousands of diabetic patients who are trying to reduce their risk of heart disease, the most common and serious complication of diabetes.

Diabetes often results in abnormal cholesterol levels that increase the risk of heart disease and cannot be easily corrected with any single cholesterol lowering drug. The LDS Hospital study found that diabetic patients already taking two cholesterol-lowering drugs to decrease high levels of LDL cholesterol and triglycerides achieved dramatic improvement with the addition of a third cholesterol-lowering drug.

The study, which is ongoing, is the first of its kind to evaluate the effect that "triple-drug therapy" has on Type II-diabetic patients who are unable to maintain cholesterol levels within national standards despite the use of one or two cholesterol-lowering medications.

LDS Hospital researchers will present results of the study on Monday at the American College of Cardiology scientific session in Atlanta.

"Perhaps, the most significant aspect of our findings is that patients achieved these increased benefits from triple-drug therapy with no additional side effects or adverse reactions. Until now, little information has existed regarding the safety and efficacy of triple-drug therapy," says Dr. Brent Muhlestein, director of cardiovascular research at LDS Hospital, and one of the authors of the study.

While dual-drug therapy with statin drugs has helped many patients improve their cholesterol profiles, the majority of patients have not been able to meet guidelines established by the National Cholesterol Educational Program (NECP). These call for LDL or "bad cholesterol" levels to be less than 100 mg/dL, HDL or "good cholesterol" levels to be greater than 40 mg/dL, and triglyceride levels to be less than 150 mg/dL.

"We knew these patients experienced a benefit from dual therapy, but not to the point where they were within the NECP-recommended thresholds. We wanted to know if they could get an additional benefit from a third drug. The answer appears to be an overwhelming yes," says Dr. Muhlestein.

All patients in the study received dual therapy with simvastatin and fenofibrate, agents that work mainly to reduce the production of cholesterol and triglycerides in the liver. They were then randomized to also receive either ezetimibe or a placebo. Ezetimibe works in the digestive tract to help block the absorption of cholesterol that comes from food or bile.

After six weeks, nearly 24 percent of the patients in the study receiving triple-drug therapy met all three NECP goals. Also, total cholesterol levels for patients receiving all three medications fell 16 percent, LDL cholesterol or "bad" levels dropped 25 percent and HDL cholesterol or "good" levels rose 14 percent.

Dr. Muhlestein says a larger clinical trial is needed to build on these findings, but the study is a very promising and appealing new approach for diabetic patients who cannot get their cholesterol within NECP ranges.

Diabetic patients are two to four times as likely to have a heart attack or stroke as someone without diabetes. Their risk of sudden death from a heart attack is the same as that of someone who has already had a heart attack Yet, despite these statistics, nearly 70 percent of people with diabetes aren't aware that they're at an increased risk of heart attack and stroke. Rather, many people with diabetes believe that foot or leg amputation and blindness are their biggest threats.

Members of the LDS Hospital research team include Robert Pearson, Heidi Thomas, Jonathan Jensen, Benjamin Horne, Donald Lappé, Jeffrey Anderson, and Dr. Muhlestein.