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Benefits Found in High Doses of Statins; Reducing Cholesterol in Heart Patients Lowers Risk of Heart Attacks, Strokes, 5-Year Study Shows

Posted on: Wednesday, 9 March 2005, 15:00 CST

Orlando, Fla. A large clinical trial has showed that lowering cholesterol in heart patients well below guidelines can significantly reduce heart attacks and strokes, although the five- year study did not show an overall reduction in deaths.

The results, which were presented here Tuesday, have increased the growing clamor to substantially lower cholesterol targets in heart patients, with some cardiologists suggesting that there may not be a level that's too low. But others have advocated a more cautious approach, saying that more research is needed before national cholesterol guidelines are changed.

"We have entered a new era in the treatment of coronary artery disease," lead author John LaRosa said at the American College of Cardiology annual conference.

LaRosa's trial, which involved 10,001 patients with coronary heart disease, compared a low and high dose of the statin drug Lipitor. The trial was funded by Pfizer, the maker of Lipitor.

Those taking the highest dose of the drug, 80 milligrams, had 22% fewer major cardiovascular events such as strokes and heart attacks, compared with those taking 10 mg of the drug. The high-dose group also saw their LDL cholesterol, the bad kind, drop to an average of 77, compared with 101 in the low-dose group. The current recommendation for such patients is an LDL level of less than 100.

"There is no safe LDL," said Robert Vogel, a professor of medicine at the University of Maryland School of Medicine. "Mine is 56, and I am thinking about lowering it."

Vogel, 61, who was not part of the new study but who has served as a consultant to Pfizer and several other companies that make statins, said he began taking a statin 15 years ago even though he was at relatively low risk for heart disease.

He said he recently had an ultrasound to measure the thickness of his carotid artery, a test to detect possible heart disease, and learned that it was equivalent to that of a 25-year-old.

However, Bertram Pitt, a cardiovascular disease specialist at the University of Michigan Medical School, said more assurance of the safety of high-dose statins is needed before lowering the LDL target.

Pitt made his comments in an editorial in the New England Journal of Medicine, where the results of the trial were published online Tuesday.

Pitt noted that the trial did not show an overall reduction in deaths. There were 26 fewer cardiovascular deaths in the high-dose group but 31 more non-cardiovascular deaths.

"Although this increase in deaths from non-cardiovascular causes could be due to chance, it is a matter of concern," wrote Pitt, who also has worked as a consultant to Pfizer and two other drug companies.

Pitt noted that some heart patients should be able to reduce their LDL cholesterol to 70 through diet and lifestyle changes, although he conceded most probably would not be able to do so.

"Until the safety and effectiveness of an 80 mg daily dose of (Lipitor) has been established, patients and physicians will need to carefully weight the benefits of a reduction in the risk of cardiovascular events . . . against the uncertainty of an increase in the risk of death from non-cardiovascular causes," he wrote.

Study author LaRosa, president of the State University of New York Downstate Medical Center, said the mortality issues were the result of the study being limited to 10,000 people. He said that at least 17,000 people would have been needed in each arm of the trial to adequately resolve death rates.

Noting that other statin trials have showed reduced cardiovascular deaths, "We have to make the assumption that mortality (benefit) is proven," he said.

But he stressed that reducing strokes and heart attacks is important as well.

LaRosa noted that troublesome liver tests, muscle aches and even the rare but potentially fatal condition rhabdomyolysis were virtually the same in both groups.

"I think it (80 mg Lipitor) is absolutely safe," he said.

Gregg Fonarow, a statin researcher and cardiologist at the UCLA Medical Center, said he believes that just getting LDL below 100 now is not enough.

"Lower is better," said Fonarow, who was not part of the study but who has worked as a consultant for statin companies. "This is something that patients should take to heart. They should know that getting their LDL below 100 isn't enough."

Sidney Smith, a cardiologist at the University of North Carolina at Chapel Hill, noted that the new trial involved only people with known heart disease.

"The benefit from this does not apply broadly to everyone," Smith said.

Two other trials looking at the potential benefit of dramatically lowering LDL cholesterol are expected to be completed in the next year.

Copyright 2005, Journal Sentinel Inc. All rights reserved. (Note: This notice does not apply to those news items already copyrighted and received through wire services or other media.)

Source: Milwaukee Journal Sentinel

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