[Note: This article has been updated to reflect the news that the risk calculator on which the new statin recommendations were based appears to be flawed.]
Statins are already one of the nation's most-prescribed drugs. Nearly one in four adults age 45 and over currently take pills like Lipitor and Zocor to manage their cholesterol levels and reduce their risk of heart disease.
And now, if new guidelines released by the American Heart Association are followed by medical practices nationwide, millions more American adults may soon be getting a prescription, although just how many millions has become a source of controversy.
The organization released its new statin recommendations last week, in partnership with the American College of Cardiology. The groups reported that a joint four-year review of current cholesterol-lowering advice led them to devise a new formula for doctors to calculate patients' risk of heart attack and stroke to better determine who should take statins.
Current guidelines have focused primarily on an individual's LDL, or "bad" cholesterol, level when deciding whether statins were appropriate. The new recommendations ask doctors also to consider age, weight, blood pressure and risk factors such as smoking and diabetes.
Estimates shared with the announcement suggested that as many as 33 million Americans, including those with at least a 7.5 percent risk of stroke or heart attack in the next decade, should start taking statins, regardless of their LDL level. Others who may be prescribed statins under the new guidelines are adults with an LDL level of at least 190, diabetics and people who have had a previous heart attack but whose LDL levels had not indicated a need for statins.
However, the organizations may be forced to backtrack on their estimates after outside experts revealed potentially serious flaws in the Risk Calculator the groups suggested doctors used to gauge risk. Those experts showed that by relying on data collected as long as a decade ago, when smoking was more common and people tended to have heart attacks and strokes at earlier ages than they do now, the committee producing the calculator appeared to have significantly overestimated individuals' potential cardiovascular risk. For some people, an apparent risk of 8 percent based on the new calculator should more accurately be measured as a 4 percent risk, the outside experts said, landing them outside the threshold for prescribing statins.
At its annual meeting last weekend, the heart association conceded that the calculator may prove to be imperfect but that it would make any changes deemed necessary and maintained that its overall change in approach would prove valid. "We recognize a potential for overestimates, especially at the high end of risk," Dr. David Goff, dean of the University of Colorado School of Public Health and co-chairman of the guideline committee's risk assessment group, told the Times.
Walking Away From Targets
While initial estimates may have proven to be overstated, the new approach still represents a sea change in determining who needs statins and who does not. In another major departure from previous advice, many people without other health risks who are currently taking statins only because their doctors want to reduce their LDL levels — the typical goal is 70 — may no longer need to take those drugs.
Committee members said that while they found clear evidence that the use of statins reduced one's risk for heart attack and stroke, they saw no scientific basis for believing that achieving any specific LDL level lowered patients' risk. "We deliberated for several years and could not come up with solid evidence for targets," chairman Neil Stone, a professor of preventive cardiology at Northwestern University's Feinberg School of Medicine, told The New York Times.
The U.S. Department of Veterans Affairs acted ahead of the committee, deciding a year ago to drop specific LDL targets for patients in its health system, the nation's largest.
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Additionally, many patients who have been taking additional drugs like Zetia designed to work in tandem with statins to reduce LDL levels may now be told they no longer need to take the second drug. The committee reported that such medications have not been proven to help reduce the risk of heart attack or stroke.
Who's Getting a New Prescription?
The new guidelines will affect certain groups more than others. Experts commenting on initial estimates said the new standards would cover more than half of African-American men in their 50s and one in three white men in the same age group. (More middle-age African-Americans have high blood pressure, which puts them in the new at-risk group.) Virtually all American men in their 70s, and more than half of all African-American women in their 60s, appeared headed to end up on statin regimens if their doctors were to have adhered to the new standards. Again, the actual numbers will likely fall short of those projections when the risk calculator is recalibrated, but should still lead to a significant rise in the number of statin users nationwide.
The main philosophical shift in the guidelines is the lessened importance of LDL levels in prescribing statins to prevent heart attacks and stroke, seeing it instead as just one factor among many. "It's really about your global risk," committee member Donald Lloyd-Jones, chair of the Department of Preventive Medicine at Northwestern University, told The Washington Post. "There were a number of people at substantial risk who, under the old paradigm, were not being captured."
American College of Cardiology vice president Kim Williams told The Washington Post, "Lower [LDL] is better, and no one's arguing that, but once you have a reason to treat someone, they should be treated fully. That's really one of the bottom lines of this."
Criticism From Several Fronts
Other experts in cardiovascular disease prevention had already come forward to question the committee's decisions on medical and psychological fronts. Some claim the new standards are too conservative. Relying on a 10-year risk of heart attack or stroke, they contend, may ignore many younger people with high cholesterol but a low risk of cardiovascular event due to their age. Such younger adults could benefit from LDL-lowering statins before their levels put them in a high-risk group.
And many doctors worry that by lessening the importance of target LDL levels, many patients and doctors will become lax about pursuing lifestyle changes. Dr. Daniel Rader, director of the preventive cardiovascular medicine and lipid clinic at the University of Pennsylvania, was initially on the committee writing the guidelines but left because he did not approve of its direction. He told The New York Times that he and his colleagues suspect that many medical practices will ignore the new advice and continue to push patients to lower their LDL level to 70 through both medication and lifestyle changes.
But the new recommendations will certainly come under fire from doctors and pharmacists who believe statins are already vastly overprescribed, given their potential side effects and the perception that they've become a crutch for people who resist dieting or exercise.
"Statins are among the most ineffective and dangerous drugs on the market, largely because the doctors who prescribe them haven't done their homework," geriatric pharmacist Armon Neel, Jr., co-author of Are Your Prescriptions Killing You?: How to Prevent Dangerous Interactions, Avoid Deadly Side Effects, and Be Healthier with Fewer Drugs, wrote in Next Avenue earlier this year.
People who are prescribed statins typically end up taking them for the rest of their lives, Neel wrote, often leading to significant muscle pain, fatigue and weakness, all known side effects of the drugs. Other studies, he wrote, have found that statin use appears to be linked to both cognitive decline and Type 2 diabetes and that the drugs can interfere with the body's ability to metabolize other essential medications.
"Exercise is probably the best way to boost protective HDL ('good') cholesterol levels," Neel wrote. "Inactive people who take up some form of regular physical activity can expect to see their HDL levels rise by as much as 20 percent." Exercise, improved diet and vitamin supplements can so successfully attack cholesterol levels, he concluded, that "we should view statins as drugs of last resort."
Advocates of the new guidelines largely dismiss those concerns. "If these were unsafe drugs, we certainly wouldn’t have put the threshold where we did," Lloyd-Jones told The Washington Post.
All involved, though, took the opportunity yesterday to emphasize that widespread use of statins wouldn't be necessary if more Americans ate healthier and exercised more. "We must get better with our lifestyle choices," Lloyd-Jones told The Washington Post. "There’s a tsunami of cardiovascular disease that’s coming, in large part because of the obesity epidemic. This is only one piece."