So what’s the problem? It’s not access, as many statins are available in generic form. Instead, the most commonly cited reason for not taking a statin is the potential side effects, specifically muscle aches or pain, stiffness, or cramps. But a new study by researchers at Oxford Public Health suggests that statins are being unfairly blamed for aches and pains that they aren’t causing. In a review of 23 placebo-controlled trials, investigators concluded that the medications are not the cause of muscle pain in over 90 percent of people who experience symptoms. According to the analysis, published on August 29 in the Lancet and presented at the 2022 European Society of Cardiology Congress, muscle pain or weakness is common in adults regardless of whether they take a statin tablet or not; in 14 out of 15 reported cases, muscle pain or weakness were not due to statin therapy, and those cases that were due to statins occurred mainly within the first year of treatment, wrote the authors. “Our research shows that, for most people taking a statin, any muscle-related symptoms they experience will not in fact be due to the statin itself — and so the potential benefits of statin therapy are likely to outweigh the muscle pain risks,” said the joint lead study author Colin Baigent, the director of the Medical Research Council Population Health Research Unit at the University of Oxford, in a press release. Previous research that implicated statins as a major cause of muscle pain are likely to have been the result of the way the data was collected and interpreted, he said. Stephen Kopecky, MD, a cardiologist and the director of the Statin Intolerance Clinic at Mayo Clinic in Rochester, Minnesota, who was not involved in this study, agrees that statin therapy is an important tool in the prevention of heart attack and stroke, but takes issue with the suggestion that the side effects that people experience during statin therapy are “inconsequential” or “insignificant.” “Because what we are then basically telling patients is that what they are experiencing isn’t real. Statin intolerance is very real,” says Dr. Kopecky.

More Than 40 Million Americans Take a Statin

Statins are the most commonly prescribed class of drugs in the United States, and it’s estimated that more than 40 million adults take them to lower their cholesterol. These medications have been shown to reduce the risk of stroke or heart attack by reducing the amount of LDL cholesterol in the blood. Too much cholesterol can lead to plaque buildup in the arteries, which it turn makes it harder for the blood to circulate, according to the Cleveland Clinic. This can lead to a heart attack or stroke, which under the umbrella of heart disease is the number one cause of death in the United States, killing an estimated 696,962 people annually.

To look at effects of statin therapy on muscle symptoms across many different types of patients, researchers gathered together data from 23 large-scale randomized studies from the Cholesterol Treatment Trialists’ Collaboration, including information from almost 155,000 individuals. Key findings of the analysis included:

Muscle symptoms such as muscle pain or weakness were common, even in trial participants who were given a placebo tablet. In 19 trials of statin therapy versus placebo, similar numbers of people reported such symptoms (16,835; 27.1 percent) in the statin group and (16,446; 26.6 percent) in the placebo group.Statin treatments marginally increased the frequency of muscle-related symptoms. In those taking statins, about 14 out of 15 reports of muscle symptoms were not attributed to statins, and in people taking high dose statins, that fell to about 9 in 10 for patients. This means that statins are not the cause of muscle pain in over 90 percent of people who report symptoms, wrote the authors.Most of the reports of muscle symptoms in those taking statins occurred within the first year of treatment. After the first year of starting treatment, low or moderate dose statin therapy didn’t cause an increase in the frequency of muscle symptoms.Higher intensity or higher dose statin treatments were more likely than low or moderate intensity statins to increase the risk of muscle symptoms with some persistent effect after the first year, though the authors did not observe evidence of a relationship between the statin dose and muscle symptoms.

Patients frequently express concerns about statins because of anecdotal information from friends and family who didn’t tolerate them, says Helene Glassberg, MD, a cardiologist at Penn Medicine in Philadelphia. “Aches and pains are quite common, and probably too frequently blamed on statin use. I find it very helpful to discuss it up front, to be aware of what aches and pains they already have so we aren’t later unnecessarily blaming the statin,” she says. The authors concluded that the risk of muscle symptoms is greatly outweighed by the benefits of statin therapy in preventing cardiovascular disease, including heart attacks and strokes. To illustrate their point, they use the following example: For every 1,000 people taking a moderate intensity statin, the treatment would cause 11 episodes of muscle pain or weakness, but would typically prevent 50 major vascular events, such as heart attacks and strokes, in those with preexisting vascular disease (secondary prevention), and 25 major vascular events if used for primary prevention. The use of a statin for secondary prevention of cardiovascular disease means the patient has already had a heart attack, stroke, or coronary revascularization procedure (such as a stent or a bypass); when statins are used in primary prevention, they’re intended to prevent the first occurrence of a heart attack or stroke.

Analysis ‘Screens Out’ Many People Who May Have Had Trouble Taking a Statin

The low percentages of people reporting muscle-related side effects in this analysis is somewhat misleading, says Kopecky. That’s because about half the patients who might have been included in these studies were left out, he says. “Some of the studies used in this analysis actually had ‘run-in’ phases where patients were given a statin before they were randomly placed into an arm of the trial,” he says. This can be part of a trial’s screening process, and if a person doesn’t meet the criteria, they are considered a “screen failure” and not included in the study, he explains. “That’s important, because sometimes this screen failure is because the person didn’t take the pills, or they experienced side effects, and that accounted for about 23 percent of the people who could have been included in this analysis,” says Kopecky. “Another 30 percent, or about 48,000 patients, were excluded from the studies in this analysis because they had a history of statin intolerance — that means they had taken them before and had trouble with them,” he says. In some ways, it’s surprising that the study found as much intolerance as it did after half the patients were “screened out," adds Kopecky.

Having Side Effects With a Statin? Make Sure to Talk With Your Doctor to Find a Treatment That Works for You

“We need to have a conversation with patients. I tell my patients, ‘There can be side effects — some people get them, some people don’t. We can’t predict it, but we can find one of the statins that will work for you and help reduce your risk for heart attack or stroke, and your risk of death due to a cardiovascular event,’” says Kopecky. Just because a person has side effects with one statin doesn’t mean they will be intolerant of the whole class — it may take a little time and patience to find the right one, he says. Once Kopecky prescribes a statin to a patient, he tells them that it’s okay to stop taking it if they start to hurt, but they must tell him via the patient portal. “They get off it for a month, which is safe, even if they’ve had a heart attack, and then we start them on a different statin and see how that goes,” he says. “What I don’t want to see — but I’ve seen way too often — is people who are prescribed a statin, it causes side effects, and they stop taking it without telling their doctor, and then a few years later we see them again because they’ve had another heart attack or another stent. It’s important to have a two-way conversation to achieve the best outcomes,” says Kopecky.