by Ron Winslow, online.wsj.com
The long-standing strategy of reducing heart-attack risk by lowering cholesterol to specific targets is being jettisoned under new clinical guidelines unveiled Tuesday that mark the biggest shift in cardiovascular- disease prevention in nearly three decades.
Gone is the familiar and easy-to-understand guidance to keep LDL, or bad cholesterol, below 100 or below 70 for people at high risk—a mainstay of current prevention policy. Instead, doctors are being told to assess a patient's risk more broadly and prescribe cholesterol-lowering statin drugs to those falling within one of four risk categories.
The aim is to more effectively direct statin treatment to patients with the most to gain, and move away from relatively arbitrary treatment targets that are less reliable in predicting risk than is widely believed.
"We're trying to focus the most appropriate therapy to prevent heart attack and stroke ... in a wide range of patients," said Neil J. Stone, professor of medicine at Northwestern University Feinberg School of Medicine and head of the expert panel that wrote the cholesterol guidelines.
Cardiovascular disease is the Western world's leading killer. In the U.S., heart disease accounts for about 600,000 deaths each year, or about one in four deaths. About 130,000 people in the U.S. die each year of stroke, which is also a major cause of disability.
Numerous studies show that statins, which are among the most prescribed drugs in the world, reduce the risk of heart attack and stroke. But solid data demonstrating the benefit of reaching specific targets are lacking, said Dr. Stone.
While lowering LDL remains a critical goal, the focus is on the risk reduction achieved with statins rather than the effect on LDL, said Donald Lloyd-Jones, chief of preventive medicine at Northwestern and a member of the guidelines panel.
Cardiologists expect the recommendations, jointly developed by the American College of Cardiology and the American Heart Association, to substantially change the conversation between doctors and tens of millions of patients over the best way to lower their risk of a heart attack or stroke.
The risk groups identified in the guidelines include patients who have already had a heart attack, stroke or major symptoms of cardiovascular disease; those with an LDL of 190 or higher, which typically has a genetic cause; people with diabetes; and anyone ages 40 to 79 who faces a 7.5% risk of having a heart attack over the next 10 years, according to a new risk score. That score—with a lower threshold than under current guidelines—takes into account cholesterol level, smoking status, blood pressure and other factors.
All are recommended to take high or moderate statin doses that would results in LDL reductions of about 30% to more than 50%.
If fully implemented, the guidelines could more than double the number of Americans who qualify for statin therapy, to more than 30 million, the authors estimated.
The new approach is likely to have a modest immediate effect on the pharmaceutical industry. All but one of the statins available, including Lipitor, have lost patent protection and are available as inexpensive generics.
AstraZeneca AZN.LN -0.23% PLC's Crestor, the one remaining branded statin and the most powerful on the market, could get a boost from the recommendations. Merck MRK +1.30% & Co.'s Zetia, a non-statin cholesterol-reducer that is also an ingredient in Vytorin, could take a hit because the guidelines discourage use of agents that haven't been proven to reduce risk of bad events. Zetia hasn't been shown to reduce bad events even though it lowers LDL.
But both supporters and critics of the new guidelines worry they will confuse patients and physicians, and potentially disrupt an easy-to-understand and successful strategy. While statins haven't been the only factor, research shows there has been a significant reduction in heart attacks and death from cardiovascular disease in the past two decades since the drugs were introduced.
"This is a tension between the practical and the scientific," said Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic. Having targets for LDL "gives doctors and patients something to shoot for" as well as a motivation to try to get there, Dr. Nissen said. "The elimination of target levels is going to be a huge change for physicians and patients."
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