Evidence Overwhelming -- Women, Senior Citizens Benefit From Cholesterol-Lowering Drug

December 16, 1997

DALLAS -- Cholesterol-lowering drugs reduced heart attack risk in women and senior citizens by 34 percent -- about the same amount as in younger men, according to a report in today's American Heart Association journal Circulation.

Since most research studies have included young or middle-aged males, researchers until now have not shown that other population groups also can avoid heart attack by taking the cholesterol-lowering drugs called statins, according to study's lead author, Tatu A. Miettinen, M.D. He is professor of internal medicine of the University of Helsinki, Finland.

In an accompanying Circulation editorial, Elizabeth Barrett-Connor, M.D., of the University of California at San Diego says, "The evidence is now overwhelming that lipid-lowering therapy is appropriate for essentially all men and women with coronary heart disease.

"In post-menopausal women, the drugs are significantly more effective in lowering total and LDL cholesterol (the "bad" cholesterol) than hormone replacement therapy, and they are less likely to cause side effects," she adds.

Physicians, according to the American Heart Association, have under-prescribed statin drugs and other cholesterol-lowering therapy. Studies such as this investigation should help turn the tide, says Miettinen.

"We should reduce serum cholesterol values more effectively and more frequently in coronary patients, even in women and those at an older age," says Miettinen. "The study supports the role of lipid-lowering therapy in saving lives, particularly in the elderly, and in reducing hospitalizations for patients with a history of heart and blood vessel disease. Statins should be considered for individuals with coronary heart disease provided no other disease, clearly shortening life expectancy, is co-existing."

The investigation, called the Scandinavian Simvastatin Survival Study (4S) study, enrolled 4,444 individuals at 94 sites throughout the Nordic countries. In 1994, 4S researchers reported a 42 percent reduction in risk of coronary heart disease events -- defined as death resulting from coronary heart disease or heart attack -- and a 34 percent reduction in risk of a non-fatal heart attack. In individuals with coronary heart disease who took simvastatin, there was a 30 percent reduction in relative risk for death from all causes.

The current research provides an in-depth assessment of the safety and effectiveness of simvastatin in 827 women and 1,021 men and women who were 65 or older at the start of the 4S study. Women taking simvastatin had 34 percent fewer major coronary events, including coronary deaths and non-fatal heart attacks -- identical to the reduction found for men taking the drug. Women also needed fewer cardiac bypass surgeries or angioplasty procedures to open blood vessels clogged by atherosclerosis. There were too few deaths among the women for meaningful assessment of simvastatin's effect on total deaths or coronary heart disease death in women.

Senior citizens experienced 34 percent fewer major coronary events -- mainly coronary deaths and non-fatal heart attacks. Much of that reduction was due to a 43 percent lower risk of dying from coronary heart disease among senior citizens in the simvastatin group.

The drug had virtually no side effects, according to the scientists. However, some individuals in both groups stopped taking the drugs because they developed elevated liver enzymes.

All of the individuals had moderately high blood cholesterol levels -- between 201 milligrams per deciliter (mg/dL) and 309 mg/dL -- when they began taking either simvastatin or a placebo (a dummy pill).

Simvastatin is one of several statin drugs that work by interfering with the body's ability to manufacture cholesterol. Cholesterol is a fatty substance that is transported in combination with proteins and other lipids in the blood vessels, leading to blockages that obstruct blood flow, setting the stage for a heart attack or stroke.

The research was supported by a grant from Merck Research Laboratories, Rahway, N.J.

Co-authors include Kalevi Pyorala, M.D.; Anders G. Olsson, M.D.; Thomas A. Musliner, M.D.; Thomas J. Cook, H.M.S.; Ole Faergeman, M.D.; Kare Berg, M.D.; Terje Pedersen, M.D.; and John Kjekshus, M.D.
Media advisory: Dr. Miettinen can be reached at 011-358-9-471-2220. His fax number is 358-9-4714013. (Please do not publish numbers.)

American Heart Association

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