Multicenter study shows Benecol spread significantly reduces cholesterol levels in patients taking statin drugs

June 26, 2000

DALLAS, TX, June 27, 2000 - Patients controlling their high cholesterol levels with statin drugs achieved further significant reductions in cholesterol by adding Benecol® spread to their diet, according to a multicenter study published in the July 1, 2000 issue of the American Journal of Cardiology. Benecol contains plant stanol esters, a unique ingredient known to inhibit the absorption of cholesterol in the gastrointestinal tract.

In the eight-week study, Benecol lowered blood levels of low-density lipoprotein cholesterol (LDL-C, the "bad" cholesterol) by 17 percent and total cholesterol by 12 percent, compared with seven percent and five percent, respectively, for placebo (canola oil spread). The cholesterol-lowering effect of the stanol ester spread was evident by the second week of the study.

"The cholesterol reduction we saw with Benecol is important because it is generally recognized that every one percent decrease in cholesterol levels translates to a two to three percent decrease in coronary heart disease risk," said lead investigator Steven Blair, P.E.D., Director of Research at The Cooper Institute in Dallas.

"Our findings are good news for patients taking statin drugs, especially for those who have not reached their goal cholesterol level," he said. He noted a recent study showing 60 percent of patients treated with statin drugs alone had not reached their goal level of LDL-C , and that the degree of LDL reduction seen with Benecol in his study was more than can be expected with a doubling of a typical statin dose.

"This is one of the first major studies to prove that a food product enhances the beneficial effect of a drug," said William C. Roberts, MD, Medical Director of the Baylor Cardiovascular Institute in Dallas and Editor-in-Chief of the American Journal of Cardiology. He explained that stanols and statin drugs lower blood cholesterol levels through different mechanisms: statins decrease its synthesis in the liver, and stanols decrease cholesterol absorption in the intestinal tract. He continued, "In fact, both mechanisms work independently of each other, making the combination ideal for people who are interested in lowering their cholesterol." Previous large-scale studies on Benecol focused on individuals who were using it without drug therapy to lower their cholesterol.

The randomized, double-blind study included 148 patients who were stabilized on statin drugs for at least 90 days and who had moderately elevated LDL-C levels. Each day they consumed either three servings of stanol ester spread or a placebo spread made from canola oil, and their blood lipid levels were monitored at two, four and eight weeks during the study. No significant changes in blood levels of triglycerides or high-density lipoproteins (the "good" cholesterol) were seen in either group. The rate of adverse events was the same for both groups.

"The improvement from Benecol was remarkable in a number of patients," said Dr. Kenneth Cooper, Founder and President of The Cooper Aerobics Center. He cited a case of one patient in his mid-sixties with a long history of heart disease. The statin drug Lipitor® (20 mg twice a day) reduced his cholesterol from 283 to 208, which was still not low enough. "By simply adding Benecol to his diet, his total cholesterol dropped to 161," he said.

Benecol also reduced total cholesterol levels of study participant Jeff Quan from 303 total cholesterol on the statin drug Pravachol® to 241 two months after adding the stanol ester spread.

"I was thoroughly amazed by how well the Benecol and the Pravachol worked to reduce my total cholesterol," said Quan.
Patients in the study averaged about 56 years old, had an average LDL level of 148 mg/dl and were stabilized on a statin drug for a minimum of 90 days before the trial. Statin drugs included Lipitor, Zocor®, Pravachol, or Mevacor®. The trial also included patients treated by investigators at other health centers: David Capuzzi, MD, PhD, and John Morgan, MD, Jefferson Medical College, Philadelphia; Sidney Gottlieb, MD, FACC, Midatlantic Cardiovascular Associates, Baltimore; Tu Nguyen, MD, Mayo Clinic, Rochester; and Nilo Cater, MD, University of Texas Southwestern Medical Center, Dallas. The study was funded by McNeil Consumer Healthcare.

Benecol, distributed by McNeil Consumer Healthcare, a division of Johnson & Johnson, is the only product containing plant stanols available in the U.S., and can be found in the dairy section of the grocery store.

The Cooper Institute is one of seven divisions of The Cooper Aerobics Center, led by founder and president, Kenneth Cooper, MD, M.P.H. The Institute is involved in a variety of research and education efforts including: analyzing the relationship between physical activity and physical fitness with various diseases; determining effective ways to encourage inactive persons to become and stay active; and using exercise as an effective treatment for depression. The Institute has published many influential papers in major scientific research journals.

Note to editors: Drs. Blair, Cater and Roberts are available for interviews. Photos, VNR and b-roll available. Contact Julie McQuain 212-477-0472.

JMPR Associates, Inc.

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