WASHINGTON — Millions more Americans could end up taking cholesterol-lowering statin drugs under new recommendations released Tuesday that advocate a dramatic shift in the way doctors assess and treat cardiovascular risk.
Roughly a quarter of Americans age 45 and older already take statins, which include familiar brands such as Lipitor and Zocor, to treat high cholesterol. But that number could grow sharply under far-reaching guidelines detailed by the American Heart Association and the American College of Cardiology.
At the core of the recommendations, which resulted from a four-year review of medical research, lies a new formula intended to help physicians calculate the chances of heart attacks and stroke in patients, particularly those in certain risk categories.
That represents a sea change from the approach that has persisted for more than a decade, of focusing intently on the level of a patient’s low-density lipoproteins (LDL) – the “bad cholesterol.”
Instead, the new guidelines encourage doctors to consider age, weight, blood pressure and other factors, such as whether patients smoke or have diabetes. If a person appears to have even a moderate risk of a heart attack or stroke, he or she should be prescribed statins, regardless of LDL score.
“It’s really about your global risk,” said Donald Lloyd-Jones, chair of the Department of Preventive Medicine at Northwestern University and one of 20 experts on the committee that wrote the new guidelines. “There were a number of people at substantial risk who, under the old paradigm, were not being captured.”
Heart disease remains the nation’s leading killer of men and women. About one in every four deaths in the United States, or about 600,000 annually, are attributed to heart disease, according to the Centers for Disease Control and Prevention. More than 700,000 Americans suffer heart attacks each year, and the costs of coronary heart disease – from health care to lost productivity – exceed $100 billion annually, the agency has said. In addition, strokes kill another 130,000 people a year.
The new recommendations call for prescribing statins to an estimated 33 million Americans who don’t have cardiovascular disease but who have a 7.5 percent or higher risk for a heart attack or stroke over the next decade. Examples of groups that could fall into that category include white women over 60 who smoke and African American men over 50 with high blood pressure.
Roger Blumenthal, director of the Ciccarone Preventive Cardiology Center at Johns Hopkins University, said about 50 or 60 percent of African American men and a third of white men in their 50s probably will qualify for treatment under the new regime. African American men tend to have higher blood pressure than their white counterparts. Similarly, a majority of black women in their 60s and a third of white women the same age are likely to end up on the medications, along with most men in their 70s and older.
That doesn’t mean every man over 70 will be put on statins, said Blumenthal, who represents the American College of Cardiology on a committee at the National Institutes of Health that is helping to foster the adoption of the new guidelines. Primary-care physicians and cardiologists will use the guidelines as a starting point in treating their patients. But overall, the doctors said they expect a significant increase in the number of people taking statins, and a decrease in the use of other drugs that are prescribed along with them in an attempt to lower LDL levels.
The four risk groups include previous victims of heart attack, stroke or cardiovascular disease; people with an LDL of 190 or higher; people with diabetes; and anyone over 40 with a 7.5 percent risk of a heart attack in the next 10 years.
Jonathan Reiner, a cardiologist at George Washington University Hospital who has treated former vice president Richard Cheney, said the previous philosophy of focusing almost exclusively on lowering LDL levels, often by prescribing multiple drugs, was not based on “a lot of robust data.” The new approach “is reinforcing what the clinical trials have shown, and are trying to move clinicians away from practices that are not based on clinical evidence.”
He said the new guidelines might make life easier for heart patients, who currently must have their blood tested several times a year to ensure that they are meeting, or heading toward, their best possible cholesterol score. Now that may not be necessary, he said.
That’s not to say that cholesterol scores no longer matter, but rather they should be only one of numerous factors in determining who should be taking statins.
“Lower LDL is better, and no one’s arguing that, but once you have a reason to treat someone, they should be treated fully,” said Kim Williams, vice president of the American College of Cardiology. “That’s really one of the bottom lines of this.”
Statins aren’t entirely without risks. Muscle soreness and fatigue are the most common side effects of taking the drugs. Other, less likely, consequences include liver damage, digestive problems, rashes or flushing, elevated blood sugar or Type 2 diabetes, and memory loss. In addition, once a person begins taking statins, he is likely to remain on them for the rest of his life.
Lloyd-Jones, the Northwestern doctor who helped develop the new guidelines, said there’s overwhelming consensus in the medical world that statins are effective and safe. “If these were unsafe drugs, we certainly wouldn’t have put the threshold where we did,” he said.
He said that while wider use of statins will probably prevent heart attacks and strokes and improve the quality of life for more patients, Tuesday’s recommendations aren’t going to solve the nation’s looming cardiovascular crisis.
“Underlying all this is the fact we must get better with our lifestyle choices. There’s a tsunami of cardiovascular disease that’s coming, in large part because of the obesity epidemic,” Lloyd-Jones said. “This is only one piece. But there’s clearly a lot more to do.”