Striking Benefits Found In Ultra-Low Cholesterol

About 64 million Americans have cardiovascular disease, and about 1.4 million die of it each year.

An estimated 11 million Americans take the drugs, which have proved to safely reduce the risk that people will develop cardiovascular disease, suffer chest pain, have heart attacks or strokes, or die from any of those causes. But even under existing guidelines, more than three times that number, about 36 million people, should be taking the drugs. Worldwide, only about 25 million people take the drugs, even though more than 200 million meet the existing criteria for getting them.

Evidence has been accumulating in recent years that driving cholesterol even lower than the current guidelines recommend may be produce additional benefits. A study last week showed for the first time that high dosages of the drug kept the insides of arteries from narrowing as quickly. But researchers have been hesitant to begin prescribing higher dosages of the costly drugs until they had clear evidence it would keep people healthier and reduce their risk of dying. In rare cases, the drugs can cause liver problems.

One of the two new studies involved 4,162 patients at 349 sites in eight countries who had been rushed to the emergency room because of severe chest pain or a heart attack. Before they left the hospital, doctors starting giving them either the standard dose of 40 milligrams a day of Pravachol, made by Bristol-Myers Squibb, or 80 milligrams a day of Pfizer's Lipitor, which is usually prescribed at 10 or 20 milligrams.

Over the next two and a half years, the patients getting high-dose Lipitor had their levels of low-density lipoprotein, the so-called LDL or "bad" cholesterol, plummet to about 62, from 106. Patients getting Pravachol experienced a decrease in LDL to about 95, just below the current target of no higher than 100.

The patients getting the high-dose Lipitor were 16 percent less likely to suffer chest pain, require angioplasty or bypass surgery, have another heart attack, or die from cardiovascular disease. Their chance of dying from any cause was slashed by 28 percent, and their chance of dying from heart disease was reduced by 30 percent. Surprisingly, the benefit showed up rapidly, in the first 30 days.

"This is a big step downward in the cholesterol [levels], and it made a big step down in the incidence of cardiac events," said Christopher P. Cannon, a cardiologist at Brigham and Women's Hospital in Boston who led the study. The study surprised its funder, Bristol-Myers Squibb, which sells the statin found less effective.

The second study involved 2,442 heart patients receiving care at 13 health maintenance organizations and two Department of Veterans Affairs hospitals around the country. Half the patients received standard doses of statins while the other half received high doses of Lipitor. Over the next 52 months, those receiving the high doses were 17 percent less likely to experience serious heart problems, including non-fatal or fatal heart attacks.

"I think the important message, if you're talking to patients or the average physician out there, is you have to be aggressive," said Donald Hunninghake, a professor of medicine and pharmacology at the University of Minnesota in Minneapolis who led the study.

Each year, about 1.7 million Americans are hospitalized because of a serious heart problem. The findings indicate that doctors should immediately consider putting all of them on high-dose statins, which should help reduce the toll from heart disease, Cannon and others said.

"Hopefully everyone is going to get more treatment after today," Cannon said. "I hope this change will prevent many heart attacks and strokes, cardiac procedures and deaths. This is a turning point for the field."

Three other large trials are underway to examine the question more broadly. But the findings are likely to influence treatment of heart disease even before those studies yield results, experts said.

"What this tells us is that treating cholesterol is very important, not just for high-risk patients but for everyone," Cannon said.