Since the first statin hit pharmacy shelves in 1987, the cholesterol-pills have quickly become a best-selling class of medications. So why is there such a pitched battle over making the potentially life-saving drugs available to more people?
There’s no question that statins can help prevent recurrent heart problems in people who already have heart disease, by lowering the risk of heart attack and stroke by up to 40%. That’s not in dispute, and heart experts routinely prescribe the drugs for anyone who has had a heart attack, angina or bypass surgery.
With the medications’ success in this group, however, doctors are wondering whether more people—healthy people who are at high risk of heart disease—should be taking advantage of the drugs. So in 2013, the American Heart Association and the American College of Cardiology took the unprecedented move of expanding the population who should consider a statin. Their recommendation extended the prescriptions to people with no history of a heart attack or other heart problems, but who had troubling signs that they might in the future – being older, carrying around extra pounds, smoking, having high blood pressure, high cholesterol or diabetes. Under those criteria, millions more people were now eligible for a statin.
But as with all drugs, statins have side effects. And more heart experts are voicing concern that the benefits of statins in preventing the first signs of heart problems don’t outweigh the risks, which include everything from muscle weakness to possible memory issues and even an increased risk of diabetes. Even so, not all doctors agree on how to interpret the studies, as a recent controversy over an analysis that questioned the use of statins in this way and was published in the BMJ showed.
Here is that data, along with the latest studies from leading experts, about the side effects in question—which you should weigh if you haven't had a heart event but are considering (or are already on) a statin:
1. Statins do not prevent early death or a first heart event.
In a review of statin data published in BMJ, lead author John Abramson of Harvard Medical School says that people who take statins to prevent a first heart event don’t lower their risk of dying from any cause, or from heart disease over 10 years.
Not only do statins not lower the risk of dying early, but they also don’t lower the chances of being hospitalized for a heart problem or other serious heart-related illness. The medication can lower—very slightly—the risk of having a heart attack or stroke. But that benefit is offset by the drugs' side effects. “For people with a less than 20% risk of having a heart event in 10 years, which is the vast majority for whom the statins would be prescribed under the new guidelines, we are not seeing a net benefit,” Abramson says. The paper, however, included a misinterpretation of data from another study and estimated that 18% to 20% of statin users experienced side effects; the editors of the journal have since retracted that statement. While the overall conclusions of the review aren't in question, the journal has asked an independent panel to take another look at the results.
What it means for now: There are better, more proven ways of lowering your risk of having a first heart attack or stroke. A healthy diet and exercise aren’t as easy to pick up as a prescription, but they are more effective
2. The Rx drugs may cause muscle weakness.
Statins are known to cause a range of muscle issues, from mild weakness to a rare but serious condition called rhabdomyolysis, in which muscle tissue disintegrates and releases the byproducts into the blood, where they can cause kidney damage. Most of the milder muscle complaints are reversible, and either go away or are reduced with lower doses or by switching to different statins. But, says Dr. Rita Redberg, a cardiologist at University of California San Francisco, “we don’t really know everything about these adverse events.” Some of her patients with muscle weaknesses continue to complain about their symptoms six months after stopping their statin, for example. And many studies that focus just on recording levels of an enzyme linked to muscle breakdown may miss the early signs of muscle problems, since many patients complain of not being able to finish their workouts or complete daily tasks well before their enzymes show signs of deterioration.
What it means for now: There’s still a lot that’s not known about how statins affect the muscles. For now, the risk of muscle problems, even mild ones, aren’t worth the small benefit for the heart.
3. Statins may increase diabetes risk in some people.
In a trial involving more than 17,000 people who were randomly assigned to take a statin or a placebo to prevent a first heart event, people without any risk factors for diabetes who took statins did not see an increased risk of developing diabetes compared to those taking placebo, but those at higher risk of diabetes did show a 28% higher risk of developing diabetes on the drug. The Women’s Health Initiative trial, which included more than 153,000 post-menopausal women, also found that the medications increased the risk of diabetes by 48%. Those results and other evidence were strong enough for the Food and Drug Administration (FDA) to add a warning on statin labels about increased blood sugar and diabetes risk linked to the cholesterol-lowering medications.
What it means for now: Because diabetes can increase heart disease risk, any increase in diabetes associated with statins likely negates the small benefit the drugs may provide in preventing first heart attacks
4. The drugs have been linked to cognitive problems.
This is an area that researchers are still investigating, but there are growing reports from statin users that the medications put them in a fog and contribute to memory loss. The FDA has a warning on statin drugs about potential memory loss, but a recent study involving patients followed from one year to 25 years on the drugs found that over the long term, statin-users showed lower levels of dementia. That may have to do with the fact that statins lower the burden of artery-clogging plaques, not just in the heart but in the brain as well.
What it means for now: Stay tuned; more studies are needed to fully understand how statins affect the brain, especially over decades of use.
Taken together, the data suggests that it’s risky to put healthy people on statins. So why did the leading heart experts recommend that these people take them? For one, says Abramson, studies that these groups looked at detailing the side effects of the drugs may be underestimating them; he notes that most doctors don’t ask patients about specific side effects, but rely on patients to report them, and many people don’t, simply because they don’t think a few aches and pains, for example, are related to their heart medication.
Second, says Redberg, some of the data on drugs that agencies like the FDA rely on may be skewed to underestimate side effects. Companies often have “run-in’ periods in which they give a candidate group of volunteers their drug for a few weeks and eliminate those with serious side effects. “Of course the event rate [of side effects] is going to be lower because they didn’t allow anyone who complained of adverse effects to stay in the trial,” she says.
That’s not to suggest that lowering cholesterol isn’t an important part of reducing risk of heart disease. It is. It’s just that compared to other strategies that healthy people can take advantage of, popping a pill doesn’t provide that much benefit. “There are much more effective ways—diet, exercise, and not smoking— that can prevent heart disease and help you live longer that are much more worthwhile to focus on,” says Redberg.