TUESDAY, March 2, 2004 (HealthDayNews) -- For the first time, a study shows intensive treatment with cholesterol-lowering statin drugs -- double the recommended dose -- can not only slow the progression of heart disease but perhaps reverse the damage done to arteries.
"This is the beginning of what I think will be a major paradigm shift in the way statins are used," says Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic Lerner College of Medicine and author of a report on the study in the March 3 issue of the Journal of the American Medical Association.
The study included only patients with clearly evident heart disease, those who had experienced heart attacks or had symptoms severe enough to require detailed studies of their arteries. Still, Nissen says, the finding is "a door opening to what will be a much broader application" of the results.
He believes ongoing studies will show that intensive statin treatment can significantly improve the effort to prevent heart disease in people who have elevated cholesterol levels but few or no symptoms of trouble.
"You can't have too low cholesterol levels," Nissen says. "Lowering cholesterol can always translate into significant benefits."
But an accompanying editorial by Dr. Frank M. Sacks, a professor of cardiovascular disease prevention at the Harvard School of Public Health, takes a more cautious approach.
The Cleveland study included just over 500 patients, a relatively small number, and did not report on clinically important end points, such as the incidence of heart attacks or deaths, Sacks points out.
"We need to see the results of the big clinical trials" of intensive statin therapy before it is used more widely, he says.
Reports on such trials are expected as early as this week at a meeting of the American College of Cardiology, Sacks says. Until trial results show that intensive statin therapy improves results, he says, "we should use statins at the intensity needed to achieve the national guidelines," which call for reducing levels of LDL cholesterol, the "bad" kind that clogs arteries, below 100.
However, Nissen says the Cleveland trial results have left him much more enthusiastic about intensive statin therapy. In that trial, half of a group of 502 patients with coronary heart disease serious enough to require catheterization, a detailed test of arterial damage, were given a standard daily statin dose of 40 milligrams, while the other half got 80 milligrams a day.
An advanced technique called intravascular ultrasound, which gives detailed images of blood vessels, was used to assess the condition of their arteries. After 18 months, the amount of artery-clogging plaque in patients getting the standard dose increased an average of 2.7 percent. There was a slight decrease, 0.4 percent, in those getting the double dose.
Those results can change cardiologists' view of heart disease, Nissen says. "It is now regarded as a chronically progressive disease, one that you can slow down but not stop," he says. "Essentially, with intensive treatment we got to zero progression. That is a hugely important step potentially to take."
And those results were achieved without an increase in harmful side effects for patients in the study, Nissen notes.
Again, Sacks is more wary. Other, larger studies have shown that intensive statin therapy can cause liver damage, severe enough for some patients to require hospitalization, he says.
Nissen agrees with Sacks that the forthcoming results of larger studies will tell the full story.
"I am very confident that those studies will confirm that the findings first reported in our JAMA article can hold up," Nissen says.
More information
Current guidelines for cholesterol-lowering drug therapy are described by the American Heart Association. To learn more about heart disease, visit the National Library of Medicine.
