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Too Much of a Good Thing?

By Gabrielle Redford
Statins are one of the most widely prescribed categories of drugs in the world. Yet controversy remains about who should—or shouldn’t—be taking them.

Before she was diagnosed with high cholesterol, Amy Elmquist would come home from work almost every night and settle down in front of the TV with a pint of ice cream. She was depressed, obese, and diabetic—three major risk factors for heart disease—and a routine blood test in the spring of 2017 revealed that her triglyceride levels were a mind-boggling 1,800 (anything over 500 is considered very high). “My numbers were so bad they couldn’t even calculate my LDL cholesterol,” recalls the 45-year-old finance administrator from Baltimore.

Alarmed, her primary care physician sent Elmquist to see Seth Martin, codirector of the Advanced Lipid Disorders Center at Johns Hopkins Medicine. Martin increased her daily dosage of the cholesterol-lowering medication atorvastatin and prescribed several other meds to try to get her triglycerides down. More importantly, he impressed upon her the need to completely overhaul her lifestyle.

“He told me that medicine wasn’t enough, and that if I wanted to live long enough to see my grandchildren, I had to take care of this,” she recalls.

That was all Elmquist needed to hear. She met with one of the center’s nutrition specialists and adopted the Plate Method of healthy eating: Fill half the plate with nonstarchy vegetables, a quarter of the plate with whole grains, and the remaining quarter with protein. She also bought a Fitbit to start tracking her exercise, and she tries to get in 10,000 steps a day.

A year later, she has lost 40 pounds, her diabetes is under control, and last month, Martin cut her medication dose in half. “Every time they lower another one of my medications, it feels like a victory,” says Elmquist, who is hopeful that one day, she can control both her diabetes and her cholesterol through diet and exercise alone.

The best way to lower the risk of cardiovascular disease is a subject of much debate. In 2013, the American Heart Association and the American College of Cardiology issued guidelines that recommended statins not just for those with heart disease or very high cholesterol but for people with average cholesterol levels who had another risk factor, such as diabetes. Not surprisingly, the guidelines greatly expanded the number of Americans who qualify for statins—from 43 million to 56 million, ages 40 to 75— setting off a firestorm of controversy.

On one side were those who pointed to the lifesaving role of statins in preventing heart attacks and strokes. Indeed, statins have been shown to reduce cardiac events by 44 percent in at-risk Americans, according to results of the widely cited 2009 JUPITER trial, published in The New England Journal of Medicine.

Other cardiologists worried that putting people who are otherwise healthy on statins could expose them to unnecessary side effects, most notably muscle pain. It might also remove incentives to follow a healthy diet and to exercise, which can reduce other risk factors for cardiovascular disease, including high blood pressure and diabetes.

“Diet and exercise and weight loss affect not only cholesterol but these other cardiovascular risk factors, and also protect against other diseases like cancer,” Martin says. “Statins are not meant to be a replacement for making the lifestyle changes. That’s always the foundation of treatment, and statins are really an adjunct to that. The tricky thing is, it’s not easy to make those changes.”

In 2013, almost 30 percent of the U.S. population over 40 had been prescribed a statin.

In the 1960s, physicians began to suspect that high cholesterol levels might be to blame for an epidemic of heart disease, especially in overweight and obese patients. That suspicion was borne out with the Framingham Heart Study, which showed a clear link between cholesterol and heart disease.

Further research by scientists Joe Goldstein and Michael Brown—who won the 1985 Nobel Prize in physiology or medicine for their work—revealed that in fact, it was low density lipoprotein (LDL) that was the real culprit, and that keeping LDL low could dramatically reduce the risk of heart attacks and strokes.

In 1986, the Food and Drug Administration approved lovastatin, the first medication to target LDL cholesterol, and statin use skyrocketed. In 2013, almost 30 percent of the U.S. population over 40 had been prescribed a statin, according to a JAMA study.

But those numbers—as well as the number of Americans who are eligible for statins per the 2013 guidelines—belie a more nuanced reality about statin use in America.

Approximately 50 percent of those who have been prescribed statins do not take them because of real or perceived side effects, according to a 2017 study in Annals of Internal Medicine.

And 50 percent of those for whom statin therapy is clearly indicated—who have suffered a previous heart attack or stroke, or who have genetically high cholesterol levels—have never been prescribed statins.

For those at high risk, “statins are probably the most wonderful advance in cardiovascular disease treatment in the last 50 years,” says Michael Blaha, director of clinical research for the Johns Hopkins Ciccarone Center for the Prevention of Heart Disease. “If you’ve been appropriately prescribed a statin, the importance of taking it cannot be overstated.”

The American College of Cardiology and the American Heart Association recommend cholesterol-lowering medication for four groups of adults:

  • People with heart disease, a prior heart attack or some types of stroke, or angina.
  • People with LDL cholesterol levels of 190 mg/dL or more.
  • People aged 40–75 with diabetes and LDL cholesterol levels of 70–189 mg/dL.
  • People aged 40–75 with LDL cholesterol levels of 70–189 mg/dL and an estimated 10-year risk of atherosclerotic cardiovascular disease of 7.5 percent or more.

Two categories of patients almost always qualify for statin therapy, Martin says: those who have had a heart attack already and those with a genetic disorder called familial hypercholesterolemia, which makes the body unable to remove LDL “bad” cholesterol from the blood.

If you’ve had a heart attack or stroke, statins can reduce your risk of a second heart attack by up to 50 percent, according to one study.

Likewise, if you’ve been diagnosed with familial hypercholesterolemia—or if someone in your family has suffered a heart attack or stroke at a young age— then you should talk to your doctor about taking a statin, Martin says.

In other cases where the need for a statin isn’t clear, he will often give his patients six months to a year to reform their diet and exercise habits before prescribing a statin. “Part of that decision will be measuring lipid levels and LDL cholesterol levels and seeing how that’s doing in response to whatever changes they’ve been able to make,” he says. “But it’s not like you can make some minor tweaks to your lifestyle and now you’ve done it. You have to make some serious changes.”

Blaha likewise recommends that his patients commit to lifestyle changes first before going on a statin. “You always start with diet and exercise,” he says. “A prudent heart-healthy diet is typically a Mediterranean-style diet, with fresh fruits and vegetables, high-fiber carbohydrates, nonprocessed foods, nuts, olive oil, lean protein like fish.”

For exercise, he recommends two things: “The first is moderate to vigorous exercise five days a week for 20 to 30 minutes, and also trying to get 10,000 steps a day by reducing your sitting or screen time,” he says.

“Statins are not meant to be a replacement for making the lifestyle changes. That’s always the foundation of treatment, and statins are really an adjunct to that. The tricky thing is, it’s not easy to make those changes.”

Sometimes, patients are motivated to make those changes to avoid statins and their oft-reported side effects, including muscle pain and liver damage.

While these side effects have been well-documented, they are not as prevalent as some believe, Blaha says. The GAUSS-3 study, conducted by Cleveland Clinic cardiologist Steven Nissen, showed that many patients who previously had been unable to tolerate three different statins were able to tolerate them when the statins were blindly reintroduced. “Which makes the point to us that a lot of statin side effects aren’t as attributable to statins as the patient might think,” Blaha says.

Martin noted that some patients may experience muscle pain with statin use because they expect to feel muscle pain. He terms this the nocebo effect, and it works in much the same way as the placebo effect. “The placebo effect is where you’re expecting something good to happen from a medical intervention and it does. The nocebo effect is where you’re expecting something bad to happen based on what you’ve read or heard. It’s a real effect, but it’s driven by your expectations,” Martin says.

Approximately 50 percent of those who have been prescribed statins do not take them because of real or perceived side effects.

Other reported side effects have not been well-documented, Blaha notes. “People are always attributing other things to statins. ‘I’m having a hard time remembering words; it must be my statin.’ Or ‘I’m sleeping poorly; I think it’s my statin.’ We run into these all the time. But there’s not good evidence that statins cause any of these things.”

Still, if a patient reports statin intolerance, doctors will typically prescribe a statin holiday, where the patient completely stops taking the statin for a few weeks to see if the side effect goes away. They’ll then reintroduce the statin to see if the side effect comes back. (A statin holiday should be done only with a doctor’s supervision.)

Other alternatives to daily statin therapy include reducing the dosage or using one of the longer-acting statins, including rosuvastatin or atorvastatin, that can be taken every other day or twice a week.

Finally, Martin recommends that patients consult with their physician or pharmacist to determine whether their statins are interacting with any other medication they’re on. Patients who are on medication for HIV or transplant rejection, as well as those on other medications for lipid disorders, are often more prone to side effects, Martin says.

That’s just one reason why he was so pleased to be able to reduce Amy Elmquist’s statin dose. “We wanted to minimize the risk of side effects for her,” Martin says, noting that patients like her who are on both statins and fibrates (for high triglycerides) are more prone to muscle cramps. “I was just happy to see she was doing so well.”

For Elmquist, embracing a healthier lifestyle has been transformative. “I didn’t realize how bad I was feeling until I started losing weight and getting active,” she says. “I felt so bad about myself, I didn’t date or do anything.”

She’s now engaged to a man who is fully supportive of her new lifestyle. For his birthday, she bought him a Fitbit. “It’s wonderful to have someone who supports you,” she said. “Now I have things happening in the future that I’m excited about.”

DIY Cholesterol Busters

A heart-healthy Mediterranean diet and regular exercise are the first steps toward lowering your cholesterol. If you want to improve those numbers even more, try one or more of these drug-free interventions.

Quit smoking.
Besides increasing your risk for cardiovascular disease generally, smoking is associated with lower levels of “good” HDL cholesterol, Johns Hopkins cardiologist Seth Martin says. Researchers have found that quitting smoking increased HDL cholesterol by about 30 percent, and it did so within three weeks, suggesting that at least some of the bad effects of smoking are quickly reversible.

Increase your fiber intake.
Soluble fiber, found in oats, nuts, seeds, beans, and some fruits and vegetables, binds to cholesterol in the gastrointestinal tract, helping reduce total and “bad” LDL cholesterol levels. Studies have shown that consuming 3.5 grams a day of oats (about three-quarters of a cup) lowered LDL cholesterol by 4.6 percent.

Eat fish once or twice a week.
Fatty fish including salmon, tuna, and mackerel are rich in omega-3 fatty acids, particularly EPA and DHA, which have been shown to reduce your triglyceride levels and increase HDL cholesterol. If you’re not a fish fan, you can get some of the same benefits with a fish oil supplement containing EPA and DHA.

Lose weight.
Being overweight or obese increases LDL and triglycerides and lowers HDL cholesterol. Conversely, losing even a few pounds can improve those numbers. Strive for a diet high in polyunsaturated fats (walnuts, sunflower seeds, flaxseeds, among other foods) and low in carbohydrates. Monounsaturated fats, found in olive oil, sesame oil, and avocados, for instance, have also been shown to lower LDL cholesterol levels.

Sprinkle some wheat germ on your cereal.
Plant stanols and sterols, known collectively as phytosterols, are structurally similar to cholesterol. Research has shown that when present in the intestine, they act to reduce the absorption of dietary cholesterol. Peanuts, almonds, and Brussels sprouts are also high in phytosterols, as are fortified cereals and spreads.

healthy woman on podium
Dalbert B. Vilarino

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