Dramatically escalating the fight against heart attacks and strokes, the nation's cardiologists have rewritten the guidebook on how Americans should be treated with statins and unveiled a plan that could double the number of patients taking the cholesterol-lowering drugs to about 70 million.
The new approach, presented Tuesday by the American College of Cardiology and the American Heart Assn., represents a stark shift from the way doctors have prescribed the popular drugs for most of the last decade.
Physicians who have focused on reducing the LDL cholesterol of patients who are at greatest risk of a heart attack will now be urged to refocus their efforts on using statin therapy on a wider range of at-risk patients, many of them still relatively healthy, to drive down their odds of a heart attack or stroke.
The new guidelines distinguish between patients who should get high-dose statin therapy and those who can take a lower dose less likely to cause side effects, such as muscle fatigue. They also instruct physicians to discontinue their efforts to meet strict targets for LDL, the "bad" cholesterol that's most closely linked to disease risk.
Cholesterol is essential for digestion, hormonal balance and cell function, but too much of it can gum up arteries. Crestor, Lipitor, Zocor and other statins reduce cholesterol by blocking the liver's production of the waxy substance.
Americans filled 255 million prescriptions for these and other cholesterol-lowering drugs in 2012, according to IMS Health, a research firm that tracks prescription drug trends. Yearly spending on this class of drugs peaked at $21.3 billion in 2011, declining since then as more of those brand-name medications become available as generics.
In proclaiming statins the most effective tool for preventing heart attacks and strokes, the writers of the new guidelines downplayed concerns about the medications' side effects. These include muscle aches and fatigue, a slight rise in blood sugar and, more rarely, hemorrhagic stroke and a toxic breakdown of muscle tissue called rhabdomyolysis.
Some experts worried that such side effects would become much more common as the population of statin-takers swells in response to the new guidelines. That could lead many patients to abandon the treatment and cause problems for others who stick with it.
"They underrate the risk" of important side effects such as muscle weakness and the kind of stroke that involves bleeding into the brain, said Dr. Sanjay Kaul, a Cedars-Sinai Medical Center cardiologist and UCLA professor of medicine. For patients with a comparatively low risk of heart attack or stroke — patients who essentially are still healthy — it'll be a harder sell, he said.
Under the new protocols, physicians should make an urgent case for taking statins to all patients whose high risk of having a heart attack or stroke because of plaque buildup is indisputable: those who have already suffered a heart attack or stroke, adults between the ages of 40 and 75 with Type 2 diabetes and people with exceptionally high LDL levels due to faulty genes.
The guidelines also recommend that patients with lower odds — those judged to have at least a 7.5% chance of suffering a stroke or heart attack over the next decade — be prescribed a low-dose statin to reduce their risk. The panel of cardiologists writing the guidelines devised a "risk calculator" that considers a patient's age, gender, cholesterol levels, blood pressure, smoking history and other variables to come up with an individualized probability estimate.
Until now, treatment with cholesterol-lowering drugs in the U.S. has generally been limited to patients with a 20% probability of a heart attack over the next decade — about 36 million Americans. The expanded treatment guidelines would roughly double that figure, the authors said.
That increase would be driven in part by the inclusion of people at risk of suffering ischemic stroke, a reduction in blood flow to the brain caused by arteries narrowed by plaque buildup or a breakaway blood clot.
Statins have been shown to reduce the risk of stroke as well as heart attack. But by explicitly counting stroke-prevention among statins' benefits for the first time, the authors of the new guidelines hope to extend statin therapy to more of the patients who are most susceptible to stroke, including women, African Americans and the very elderly.
Dr. Neil Stone, chief author of the new clinical practice guidelines, said Americans' health would benefit from a more vigorous approach to identifying and treating patients who are vulnerable to heart attacks and strokes, not just those with too much LDL.
"Statins treat risk, not only cholesterol," said Stone, a cardiologist and professor at Northwestern University's Feinberg School of Medicine. "They lower risk by lowering cholesterol." But he acknowledged that clinical studies had not been able to prove that lowering cholesterol to specific targets translated into lower risk that a blockage would halt blood flow to the brain or heart.
The new guidelines will align physician practices with a welter of new research showing what works — and what doesn't — in preventing heart attacks and strokes, said Dr. Steven Nissen, an influential Cleveland Clinic cardiologist who was not involved in drafting the new recommendations. The result should be fewer premature deaths and patients disabled by heart attacks and strokes, he said, although it will take years before such reductions can be tallied.
The recommendations "will require new thinking" on the part of physicians accustomed to a system with clear goals and a clearly defined group of high-risk patients, Nissen said. Doctors will have to switch to new tools to identify patients newly eligible to take statins, including the "cardiovascular risk calculator" available online.
"In practice, it's going to be a gradual shift," Nissen said.
Dr. Michael Johansen, a professor of family medicine at Ohio State University's Wexner Medical Center, said the new statin guidelines should gain acceptance from patients and physicians, despite 20 years of marketing and medical practice that fueled "the misconception that statins are for cholesterol reduction instead of a drug to prevent heart attacks and strokes."
Johansen called the new guidelines "far simpler and more effective to implement" than the current approach, which calls on doctors to prescribe additional medications to patients with stubbornly high LDL. These include cholesterol absorption inhibitors, high doses of niacin, bile acid binders and triglyceride-lowering fibrates.
As the new guidelines enter into broad use, Johansen said, both patients and physicians will be happy to scale back the use of costly non-statin cholesterol medications "that haven't been shown to make people live longer or happier lives."
The new guidelines will be published in the Journal of the American College of Cardiology and in the American Heart Assn. journal Circulation.