Healthy People Should Be Taking Cholesterol Drug, Researchers Say Heart Attacks, Other Coronary Symptoms Dramatically Reduced, Study Finds

Millions of healthy middle-aged Americans with cholesterol levels considered near normal should be on a cholesterol-lowering drug, authors of a large new study said here Wednesday.

Over a five-year period, there were 36 percent fewer first-time heart attacks and serious new coronary symptoms among several thousand people taking a cholesterol-lowering drug compared with similar individuals on low-fat diets and exercise alone.

The findings, released at the American Heart Association’s annual scientific sessions, move far beyond current cholesterol treatment guidelines, which call for giving drugs only to people with high cholesterol levels and other risks of heart disease.

For instance, for people with no known heart disease and fewer than two coronary risk factors - such as smoking and high blood pressure - federal guidelines currently recommend drug treatment only if levels of LDL, the “bad” cholesterol, exceed 190 milligrams per deciliter.

But the new study found a strong benefit from a cholesterol-lowering drug among healthy individuals with average LDL levels of 140 milligrams, only about 10 points higher than the U.S. average.

“The results carry profound implications for many adults who think they are at low risk of a heart attack,” said Dr. Antonio Gotto Jr., dean of Cornell University Medical College, who chaired the new study’s steering committee.

A cholesterol-lowering drug called lovastatin was so effective in preventing first-time heart attacks and the development of an ominous condition called unstable angina (chest pain at rest) that ethics monitors called a halt to the study last spring. The project was sponsored by Merck, makers of lovastatin (Mevacor), the first of the “statin” class of cholesterol-lowering drugs introduced a decade ago.

Dr. Rodman Starke, the heart association’s senior vice president for science and medicine, said the new results undoubtedly will force a reevaluation of federal guidelines for use of cholesterol-lowering drugs.

Even under existing guidelines, about 12 million to 14 million Americans should be on such drugs, but evidence presented here this week indicates that most are not.

Starke said the Merck study helps explain why at least half of the 1.5 million Americans who suffer heart attacks each year have cholesterol levels considered normal or only moderately elevated. “Everybody always suspected that our notions of what is ‘normal’ cholesterol are too high,” Starke said. “This study shows that is true.”

The practical implications of the study - for patients, doctors, health insurers and society at large - undoubtedly will be debated for years to come. For instance, it costs about $700 for a year’s worth of lovastatin at the average dose used in the study.

“Will insurers pay for this kind of preventive drug treatment?” wondered Dr. Christie Ballantyne, a Houston cardiologist who was not connected with the study. “If you have a wreck, your auto insurers will pay for the repair. But not for tuneups and oil changes.”

Critics previously have questioned the wisdom of putting tens of millions of people on costly cholesterollowering drugs for the rest of their lives, but that was in large part because large-scale trials had not proved the benefit in terms of lives saved and serious disease avoided.

That has changed over the past three years as a series of large, rigorous studies have shown such payoffs, first among individuals with high cholesterol who already had suffered a heart attack and now among those with near-normal cholesterol and no sign of heart disease.

“This puts cholesterol into the same category as high blood pressure,” observed one doctor Wednesday. Specialists long have urged doctors to prescribe drugs for healthy people with even moderately elevated blood pressure if diet and exercise don’t lower it.

The Merck study, which followed 6,600 men and women for nearly five years, is the first to document a benefit from cholesterol-lowering drugs among people with typical cholesterol levels and without any history of heart attack or cardiac symptoms.

Half the participants received lovastatin and half got a placebo, or inert pill; all followed a diet with 10 percent less fat content than the U.S. norm and restricted cholesterol; they all also were instructed to follow a regular regimen of thrice-weekly aerobic exercise.

Men in the study were 45 to 64 years old, while women were 55 to 64. All were “without a smidgen of evidence of heart disease,” Gotto said. Total cholesterol levels of study subjects averaged 221, a level considered “borderline high.”

Study authors said their results imply that 6.6 million Americans with no known heart disease and near-normal cholesterol levels could achieve a 36 percent reduction in their risk of a first heart attack or appearance of serious cardiac symptoms if they combine a “statin” drug with diet and exercise.

Put another way, 3.7 percent of the patients on lovastatin suffered first-time heart attacks or developed unstable angina over a five-year period compared with 5.7 percent of the group on a placebo, or fake, pill.

Those who took the drug required one-third fewer heart-bypass operations or artery-clearing angioplasty procedures during the five-year study period, saving $800,000 over the placebo group’s experience.