Cholesterol-lowering treatment with Merck's Zocor shown to save lives, prevent heart attacks in elderly.

the landmark Scandinavian Simvastatin Survival Study (4S) demonstrate that treating elderly patients who have heart disease and high cholesterol with Zocor(R) (simvastatin) reduced death due to heart disease by 43 percent and reduced death from any cause by 34 percent.

These data were presented today at the American Heart Association's 68th scientific sessions.

"Some physicians have previously questioned the value of testing and lowering cholesterol in elderly patients with elevated cholesterol," said William P. Castelli, M.D., medical director of the Framingham Cardiovascular Institute. "But this new research now definitively shows that treating elderly patients with heart disease and high cholesterol using simvastatin saves lives."

The Scandinavian Simvastatin Survival Study with Zocor is the only clinical trial to demonstrate that long-term cholesterol-lowering therapy, along with diet, substantially improves survival, prevents heart attacks and reduces the need for costly hospitalizations and surgical procedures in all patients with coronary heart disease (CHD) and high cholesterol.

The effects of cholesterol-lowering treatment on the elderly were examined in a subset of the 4,444 4S patients, who were 65-70 years old when starting the trial and were 70-75 years old by the end of the trial.

The subset was comprised of 518 patients who were treated with Zocor, and 508 patients who received placebo. Zocor produced clinical benefits in these older patients that were as significant as the benefits observed in the total patient population.

Elderly patients taking Zocor were significantly less likely to experience a cardiovascular event during the five-year study than those who received placebo. In elderly patients, treatment with Zocor:

o reduced death by 34 percent;

o reduced death by coronary heart disease by 43 percent;

o reduced major coronary events (coronary heart disease + nonfatal

heart attack) by 34 percent;

o reduced invasive procedures to clear blocked arteries by

41 percent.

"The results are unequivocally positive," said Terje Pedersen, M.D., coordinator of the Scandinavian Simvastatin Survival Study, and head of the Coronary Care Unit at Aker Hospital in Oslo, Norway. "When life expectancy is not otherwise limited, age should not disqualify a patient with coronary heart disease and high cholesterol from receiving cholesterol-lowering therapy," he added.

In the elderly patients studied, Zocor:

o reduced total cholesterol by 26 percent;

o reduced low-density lipoprotein cholesterol (LDL or "bad"

cholesterol) by 35 percent;

o increased high-density lipoprotein cholesterol (HDL or "good"

cholesterol) by 8 percent;

o reduced triglycerides by 10 percent.

About the Scandinavian Simvastatin Survival Study

In the double-blind, multicenter Scandinavian Simvastatin Survival Study, 4,444 men and women with a history of heart disease were randomly assigned to receive diet and Zocor or placebo and followed for five years. All study participants had mildly to moderately elevated cholesterol levels.

Results, which were published Nov. 19, 1994 in The Lancet, showed that treating patients with Zocor reduced overall risk of death by 30 percent and risk of coronary death by 42 percent.

"All lipid-modifying drugs are not equal in their ability to lower harmful cholesterol levels," said Prof. Anders Olsson, co-chairman of the 4S steering committee and head of the clinical research center at the University of Linkoping, Sweden. "We need to exercise caution in extrapolating the results of the Zocor survival study to other agents with different mechanisms of action."

In clinical trials, Zocor was generally well-tolerated. Most commonly reported side effects include headache (3.5 percent), abdominal pain (3.2 percent), constipation (2.3 percent), flatulence (1.9 percent), and diarrhea (1.9 percent).

In the Scandinavian Simvastatin Survival Study, rates of discontinuation due to adverse effects were comparable in the placebo group and the group treated with Zocor (13 percent with placebo vs. 10 percent with Zocor). Rarely, Zocor has been associated with liver and muscle problems. Patients experiencing unexplained muscle pain or weakness while taking Zocor should notify their doctor immediately.

Zocor, one of the class of drugs known as HMG-CoA reductase inhibitors, has been prescribed for more than 3.1 million patients worldwide since its introduction in 1988. It is now available in 90 countries. Zocor is taken as an adjunct to diet for the reduction of elevated total and LDL ("bad" cholesterol) levels in patients with primary hypercholesterolemia when response to diet has been inadequate.

Merck & Co. Inc. is a leading research-driven pharmaceutical products and services company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health.

CONTACT: Merck & Co. Inc., West Point, Pa.

Michael Seggev, 215/652-6931