Statins Have Few Side Effects, But Should More People Be Taking Them?

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Statins lower cholesterol, reduce inflammation and may be responsible for saving thousands of lives. Should everyone be taking the wonder drug?

In the latest study investigating the side effects o statins, researchers report in the journal Circulation: Cardiovascular Quality and Outcomes, that the best-selling drugs are relatively safe. And as evidence builds that statins can lower inflammation, the process responsible for many chronic illnesses, from Alzheimer’s to cancer and heart disease, some experts are suggesting that more people should be taking advantage of the prescription medication to slow down aging.

The results of the Circulation paper may bolster that idea. The study’s lead author, Huseyin Naci, a research fellow at Harvard Medical School in the department of population medicine, pooled 135 studies involving 250,000 participants and all seven of the currently available statin medications and analyzed the risk of side effects. The studies were those that drug makers submitted to the Food and Drug Administration to demonstrate the safety of their medications for approval. Naci and his colleagues found a 9% increased risk of diabetes among those who used statins compared to those who were assigned placebo pills. The rates of other side effects, including muscle pain, cancer, and changes in liver enzymes were not statistically significant.

MORE: Who Should Take Statins? The Debate Continues

Such a relatively safe side effect profile could reignite the debate over whether more people should be taking statins – or, as some researchers in the UK and US have suggested, whether everyone over age 40 or 50 should be on the medication.  Dr. David Agus, professor of medicine at the University of Southern California Keck School of Medicine, recommends that everyone over 40 should discuss statins with their doctor, even if they haven’t had heart problems or are at increased risk for heart disease or diabetes. He says that inflammation is driving a number of aging-related conditions, both in the body and brain, and since studies have shown that statins are a powerful way to dampen the inflammatory response, more people might be living longer if they take advantage of statins. Rory Collins, an epidemiologist at Oxford University, caused an uproar last year when he addressed the European Society of Cardiology with a talk entitled, “The Case for Statins In a Wider Population,” and argued that more people should be availing themselves of the medications, just as they do aspirin.

Not everyone agrees with that view, however, despite the favorable side effect profile of the drugs. “It’s a wonderful medication, but we shouldn’t be putting statins in the water supply,” says Dr. Steven Nissen, chair of cardiovascular medicine at Cleveland Clinic. Naci also says that although his analysis showed that the drugs were relatively safe, “we don’t know the long term effects of statins. If we give it everyone, then after ten or 15 years we don’t know what the slight increased risk of diabetes will amount to.” Statin drugs have been linked to an increased risk of muscle weakness as well, which was severe enough for one medication to be pulled off the market.

MORE: Should You Take Statins? Study Says Heart Benefits Outweigh Diabetes Risk

There’s no argument that patients who have already had a heart attack or heart disease can lower their risk of further heart problems by taking a statin. What’s less clear is whether people who are otherwise healthy could lower their risk enough to justify their exposure to the side effects of the medications. And to answer that question, scientists are turning to statins’ ability to reduce inflammation.

Currently, national guidelines recommend that patients start on statins based on their cholesterol levels. But doctors are investigating whether people with low cholesterol levels but high inflammation levels could benefit from statins. A recent trial showed that these patients, who under existing guidelines would not be advised to take statins, could lower their risk of a heart attack or stroke by 50% if they were taking the drug. To confirm the association between inflammation and a lower risk of heart events, Dr. Paul Ridker, director of the center for cardiovascular disease prevention at the Brigham and Women’s Hospital and a pioneer in understanding inflammation’s role in heart disease, is spearheading two trials involving heart patients on statins. Half will be randomly assigned to take another anti-inflammatory agent on top of their statin, while half will be assigned a placebo; if the group taking the anti-inflammatory agent ends up with a lower rate of heart problems, then that would support the idea that inflammation indeed plays a critical role in heart disease, and that controlling it with a statin might save more lives.

MORE: Statins: Evidence of Broader Benefits

“We already know that the risk associated with elevated inflammation is as large as the elevated risk patients have from having either high cholesterol or high blood pressure,” he says. “The question is, just as lowering blood pressure reduces risk, can we generate evidence that reducing inflammation reduces the risk of heart disease.”

Even if the results of those trials show that lowering inflammation also lowers risk of heart problems, that won’t mean that everyone should be taking a statin. “One has to be cautious about for whom we recommend [statin] therapies,” says Dr. Sidney Smith, professor of medicine at the University of North Carolina Chapel Hill and past president of the American Heart Association. “We are going to have to do a better job of identifying patients at risk who might benefit from medical therapies to reduce their risk of heart disease at a dosage that minimizes the side effects.”

That’s especially true for the youngest patients – children – who are increasingly being tested for high cholesterol levels and even prescribed the medications that most associate with middle-age. In 2008, I wrote about the American Academy of Pediatrics’ recommendation to broaden cholesterol testing to include toddlers as young as two and to consider prescribing statins for youngsters with a history of abnormally high cholesterol levels:

While the guidelines target kids with a genetic risk of abnormally high cholesterol, called hyperlipidemia, they could lower the bar for prescriptions–not just for these children but for any overweight youngster whose cholesterol is not in check. Within hours of the AAP announcement on July 7, parents took to the blogs, expressing shock and unease over the aggressiveness of the guidelines. Statins are not without risks; in adults, in rare cases, they can cause muscle weakness and kidney problems, and there are limited data on how statins affect children.

The Academy defended its position, maintaining that the benefits of addressing cholesterol in children, which can lower their risk of diabetes and heart disease, outweighed the risks of the medications. Making such risk-benefit calculations about statin use for non-heart patients continues to be a work-in-progress, says Smith, but new national guidelines may help doctors to make those calculations in the coming year. “We still need to carefully define the groups that will benefit,” he says. “I think we will do a better job of that based on studies like this and others that have come out in the past few years. Hopefully within the next year we will be able to pull some things together that will allow us to move forward and do good things for our patients.”