First approved in the late 1980s, cholesterol-lowering statin medications are now among the most widely prescribed drugs in the world. Almost 28 percent of Americans ages 40 and older—40 million in all—currently take a statin to protect against heart attacks and strokes. That’s an 80 percent increase over roughly the past decade, according to findings published in JAMA Cardiology in November 2016.
Many people who are healthy but at increased risk of developing cardiovascular disease should begin taking statins for primary prevention as well, according to recommendations from the U.S. Preventive Services Task Force (USPSTF), a panel of medical experts who evaluate scientific evidence and recommend preventive healthcare.
“There’s growing evidence that expanding statin use to people with normal cholesterol levels and at least one risk factor could further reduce heart disease rates,” says James L. Weiss, M.D., professor of cardiology at Johns Hopkins University School of Medicine in Baltimore.
The case for statins
The recommendations closely match a 2013 American Heart Association (AHA)/American College of Cardiology (ACC) guideline that proposes wider statin use to reduce the burden of cardiovascular disease.
When lovastatin, the first form of statin, was approved in 1987, it was recommended for people with cardiovascular disease or very high cholesterol levels. As evidence of the benefits of statins accumulated, health experts revised their guidelines to include patients with moderately elevated cholesterol, especially those who had other risk factors for heart disease, such as a family history of cardiovascular problems or tobacco use.
The USPSTF based its recommendations partly on a comprehensive review it commissioned to evaluate the benefits and harms of statins for cardiovascular disease prevention. Researchers reviewed 19 trials that included more than 71,000 participants with increased cardiovascular disease risk. They found that statins significantly reduced the participants’ risk of dying from cardiovascular disease, including heart attacks and strokes.
Assessing your risk
The USPSTF guidelines suggest a low-to moderate-dose statin if you are between ages 40 and 75 with no history of heart disease and have:
• One of four risk factors: dyslipidemia (abnormal levels of cholesterol and triglycerides), diabetes, high blood pressure, or smoking
• A calculated 10-year risk of a cardiovascular event, such as a heart attack or stroke, of 10 percent or greater
A risk score of greater than 10 percent is a strong indicator that a statin would help you. If you have any of the four risk factors listed above but your calculated cardiovascular risk is lower—between 7.5 and 10 percent—you should discuss with your doctor whether you might benefit from a low-dose statin. Your decision depends on your personal situation and preferences, such as your tolerance for statins and willingness to take a drug every day.
Your doctor will determine your 10-year risk with an online risk calculator, such as the risk tool developed by the AHA and ACC when they released their guideline, to assess your odds of having a heart attack or stroke over the next decade. The calculator takes factors such as your age, race, gender, cholesterol levels, blood pressure level, and smoking habits into account. Talk with your doctor about the right treatment plan for you.
“The new guidelines shift the focus from looking specifically at numeric cholesterol targets to looking at overall cardiovascular risk,” Weiss explains. “According to the recommendations, a patient with normal cholesterol levels but an elevated risk of developing heart problems over the next 10 years should consider a statin. A patient with moderately elevated cholesterol but no other risk factors, on the other hand, may not get much or any benefit from a statin.”
The case against statins
Experts agree that statins are beneficial for people at substantial risk for cardiovascular disease. What they don’t all agree on is how beneficial statins are for primary prevention in people at lower risk. In a series of editorials that accompanied the USPSTF recommendations in the November issue of the Journal of the American Medical Association, some experts debated the use of statins for primary prevention. Among the concerns expressed about the evidence:
• The adverse effects of statins, particularly muscle discomfort, may have been underreported.
• Promoting the benefits of a healthy lifestyle should play a more prominent role in primary prevention of cardiovascular disease than prescribing statins.
• Research suggests that statin users are more likely to become obese and
more sedentary than nonstatin users because patients mistakenly believe that taking a statin replaces the need to exercise and eat a healthy diet.
• Most of the studies the USPSTF used to base its conclusions on were funded by statin manufacturers, which might have led to biased findings.
Long-term statin therapy isn’t without potential side effects. Being aware of adverse effects associated with statins can help you spot any issues early and alert your doctor to them:
• Mild muscle discomfort. Myalgias, or muscle aches, are the most commonly reported side effects. Yet, the USPSTF review found no clear association between statins and muscle symptoms. Other clinical trials have found that both patients taking statins and those taking placebos often reported muscle pain, a result that has confounded researchers.
• Impaired memory. Since 2012, statin labels have included a warning about the possibility of “ill-defined memory loss” and “confusion.” But the caution is based on case reports and small studies. The USPSTF found no clear evidence that statins were associated with memory problems.
• New-onset diabetes. This small risk is largely seen in people who already have risk factors for diabetes, such as obesity or chronically high blood sugar, and who use high-dose statins.
• Hemorrhagic stroke. While statins lower the risk of ischemic strokes (caused by a blood clot), they’ve been found to slightly increase the danger of the less common hemorrhagic strokes (caused by a ruptured blood vessel in the brain).
• Liver injury. Though liver injury is rare, your doctor will measure your liver enzymes before you start a statin and repeat the test only if there are liver damage symptoms, such as jaundice.
• Cataracts. One study of more than 46,000 people found that statin users were 27 percent more likely than nonusers to develop cataracts. But other studies have found no such link.
“Any adverse side effects should be taken seriously,” Weiss says. “Muscle pain and memory concerns can often be addressed by lowering the dose or shifting to a different statin. For many people at risk of cardiovascular disease, the benefits of statins far outweigh the harms.”
What about older adults?
Although the new recommendations provide welcome guidance, they leave some important questions unanswered. The guidelines include people ages 40 to 75, for example. But is it safe to begin taking a statin at age 75? And if you’ve been taking statins in your 50s and 60s, is it safe to continue taking them as you get older?
Unfortunately, researchers don’t have hard-and-fast answers to those questions, simply because few studies in older patients have been conducted. Some experts worry that muscle pain and weakness may be a more common and serious side effect in older people and could result in potentially dangerous falls.
Other drugs commonly taken by older patients, including many for heart disease, such as blood thinners, calcium channel blockers, and fibrates, may interact with statins to increase the risk of muscle pain and weakness.
Like all official health guidelines, the latest statin recommendations are designed to guide doctors and patients. “In the end, it’s always important to talk with your doctor to make a decision that’s right for you, based on your age, health, risk factors, and personal preferences,” Weiss says. “As we learn more about risks and benefits in older people, we’ll be better able to make informed decisions.”
An alternative to pills
Healthy lifestyle changes can go a long way toward protecting against cardiovascular disease. Some things you can do to control modifiable risk factors:
• Eat a balanced diet rich in fruits, vegetables, whole grains, beans, and nuts.
• Increase physical activity. Get 30 minutes or more of moderate-intensity physical activity five days a week.
• Maintain a healthy weight.
• Don’t smoke.
• Drink alcohol in moderation—no more than one or two drinks a day.
• Reduce stress.
• Get an annual flu shot.
Should you consider a statin?
If you’re not taking a statin to prevent a first-time heart attack or stroke, do the latest guidelines mean you should start? You may be a candidate for a low- to moderate-dose statin if you:
1. Are age 40 to 75 and
2. Have no known cardiovascular disease or symptoms and
3. Have one or more of the following:
• An elevated low-density lipoprotein cholesterol level (>130 mg/dL) or a low high-density lipoprotein level (<40 mg/dL)
• High blood pressure
• A smoking habit
4. A calculated 10-year risk of cardiovascular disease of 7.5 percent or greater