High Doses of Statins Can Lead to Reduced Risk for Heart Disease, Study Finds
High doses of cholesterol-lowering statins can "sharply boost protection" against heart disease and increase heart attack patients' survival rates while dramatically lowering levels of LDL, the so-called bad cholesterol, according to a study released Monday at a meeting of the American College of Cardiology in New Orleans, the Washington Post reports. According to the Post, the study is expected to "transform the treatment of the nation's leading killer," and the results "provide the first direct answer to one of the most important questions being debated about heart disease: Will pushing cholesterol levels even lower than currently recommended help more people avoid getting sick and dying?" The study, which will be published in the April 8 issue of the New England Journal of Medicine, involved 4,162 patients at 349 sites in eight countries who arrived in emergency departments with severe chest pain or heart attacks. Dr. Christopher Cannon, a cardiologist at Brigham and Women's Hospital, and colleagues divided the patients upon discharge into one group that received a standard dose of 40 milligrams per day of Pravachol, manufactured by study sponsor Bristol-Myers Squibb, or 80 milligrams per day of Pfizer's Lipitor, which is usually prescribed at doses of 10 or 20 milligrams.
The group receiving the high-dose Lipitor lowered their LDL levels from 106 to about 62 (Stein, Washington Post, 3/9). Meanwhile, the Pravachol group lowered their LDL to an average of 95 (Maugh, Los Angeles Times, 3/9). Current national guidelines indicate that LDL levels should be lower than 100 in high-risk patients (Kolata, New York Times, 3/9). Researchers found that over 2.5 years, patients in the high-dose Lipitor group were 16 times less likely to experience chest pain, require angioplasty or bypass surgery, have another heart attack or die from cardiovascular disease. The Lipitor patients' chance of dying from any cause decreased by 28%, and their chance of dying from heart disease was reduced by 30%. Benefits from the drug appeared within 30 days (Washington Post, 3/9). Broader, placebo-controlled trials of standard doses of statins have not shown benefits until 12 to 24 months after patients began taking the drugs (Winslow, Wall Street Journal, 3/9). The statins were more effective in women than men (Los Angeles Times, 3/9).
According to the New York Times, researchers said that "they were particularly surprised because the study was intended to show that Pravachol was just as effective as Lipitor"; in the contract with study sponsor BMS, researchers specified that the results would be published regardless of the results. "A lot of people believed that lower [LDL levels are] better," Dr. Daniel Rader, director of preventive cardiology at the University of Pennsylvania School of Medicine, said, adding, "But no one thought that this would be the study to prove it. It was designed to prove the opposite." The findings are "yet another piece of bad news" for BMS, which has been losing market share on Pravachol to other statins, the Times reports (New York Times, 3/9).
A recently released study of 2,442 heart patients receiving care through 13 health maintenance organizations and two Department of Veterans Affairs hospitals nationwide supports the results of Cannon's research. In the study, Donald Hunninghake, a professor of medicine and pharmacology at the University of Minnesota-Minneapolis, and colleagues divided patients into one group that received standard doses of statins and another group that received high doses of Lipitor. Over 52 months, patients in the high-dose Lipitor group were 17% less likely to experience serious heart problems, including non-fatal or fatal heart attacks. Three other large trials are underway to examine the use of high-dose statins (Washington Post, 3/9).
The findings, along with similar studies touting the benefits of statins, are causing "a sea change in cardiovascular prevention" that will "mean a major change in the daily practice of medicine," Dr. Eric Topol, chair of the department of cardiovascular medicine at the Cleveland Clinic and author of an editorial appearing with Cannon's study, said (Los Angeles Times, 3/9). Topol added, "Already 12 million people [in the United States] take statins, but they're having cholesterol levels that are not low enough" (Anderson, Atlanta Journal-Constitution, 3/9). Dr. Thomas Pearson, head of preventive medicine at the University of Rochester and an author of the current LDL level guidelines, said, "The goal of less than 100 was an approximation using some very early data. It was the best guess at that moment. It may need some improvement" (Haney, AP/Newport News Daily Press, 3/8). The findings suggest that as many as 25 million more people at risk of heart disease should take statins, the Atlanta Journal-Constitution reports (Atlanta Journal-Constitution, 3/9). The research suggests "all [heart attack patients] should receive them, and they should receive much higher doses than are now used," according to Cannon, the Los Angeles Times reports. He added that while his study specifically found Lipitor to be effective at high doses, "similar results would probably be obtained if any of the statins, including Pravachol, were used at the same high levels," according to the Los Angeles Times (Los Angeles Times, 3/9).
Several broadcast programs reported on the study:
- ABCNews' "World News Tonight": The segment includes comments from Cannon and Topol (McKenzie, "World News Tonight," ABCNews, 3/8).
- NPR's "All Things Considered": The segment includes comments from Cannon, Topol and Dr. Sidney Smith of the University of North Carolina (Knox, "All Things Considered," NPR, 3/8). The complete segment is available online in RealPlayer.
- NPR's "Morning Edition": NPR's Renee Montagne interviews NPR's Richard Knox about the study. The segment also includes comments from Cannon (Montagne, "Morning Edition," NPR, 3/9). The complete segment is available online in RealPlayer.