Are statins very risky?

Cancer. Cataracts. Confusion. Forgetfulness. Erectile dysfunction. Nerve damage. Tendonitis. Those are just some of the harms that people attribute to statins, which one in four Americans older than 40 now take to lower their LDL (“bad”) cholesterol.

Statins can cause muscle aches and weakness, but they’re rare and usually reversible.

There’s no convincing evidence that statins cause any of them, said the Amer­ican Heart Association in December 2018.

“The bottom line is that statins have a really solid track record,” says Michael Miller, director of the Center for Preventive Cardiology at the University of Maryland, who co-authored the association’s statement.

“The first statin was approved about 30 years ago, so we have three decades of experience,” notes Miller. And they’ve been tested in 27 trials on 174,000 people.

Saturated fat raises LDL (“bad”) cholesterol, which ends up as plaque in arteries. Statins make the liver produce less cholesterol and remove more LDL from the blood.

That doesn’t mean the drugs cause no problems at all.

“Clinical trials don’t enroll patients with kidney or thyroid problems or other illness,” says Miller. “In the real world, we tend to see a bit more side effects.”

Among them:

Muscle symptoms. “The typical symptom is achiness and maybe weakness,” says Miller. “But if you don’t see it on both sides of the body, it’s not likely due to statins. And it’s slightly more common in older, frail women.”

Clinical trials find muscle symptoms in about 12 percent of participants, whether they’re taking a statin or a placebo. So some people may report muscle aches because they expect to.

“The good news is that if you go off the statin, your symptoms should resolve,” says Miller.

That isn’t always true for people who get rhabdomyolysis, the most severe muscle injury from taking statins, which strikes roughly one out of every 10,000 statin takers. They have creatine kinase levels—a measure of muscle breakdown—more than 40 times higher than normal. (Most people who report muscle aches have no significant increase in creatine kinase.)

“If rhabdomyolysis is caught early, it can be reversible and you don’t have major kidney damage,” says Miller. “If somebody has brownish urine and muscle weakness, they need to be immediately seen.”

The worst offender was cerivastatin, he adds. “That medication was taken off the market in 2001.”

Liver failure. What worries patients the most? “They think that statins will destroy their liver,” says Miller. “But it’s exceedingly rare if you have no history of hepatitis or other liver disease.”

Many doctors check for that.

“Before a new patient goes on a statin, I do a comprehensive blood profile that makes sure that their liver, kidneys, and thyroid are suitable for statin therapy,” says Miller.

Diabetes. The risk of type 2 diabetes rises when people go on statins, but the disease doesn’t come out of the blue.

“I am not aware anywhere in the literature of somebody with perfectly normal blood sugar—let’s say 90—who went on a statin and all of a sudden became diabetic,” says Miller.

Instead, statins may push people with prediabetes over the line to diabetes, which is a fasting blood sugar over 125.

“On average, fasting blood sugar levels go up somewhere between two to five points in people on statins,” says Miller. “So people who have a fasting blood sugar of 122 may go on a statin and, lo and behold, their blood sugar is 126 or 127.”

That’s no reason to avoid statins.

“Statins not only lower the risk of cardiovascular events in people with diabetes,” says Miller, “they also reduce the risk of some of the microvascular complications in diabetes, like blood vessel damage in the eyes.

“So we don’t want to throw the baby out with the bathwater by saying ‘Don’t take a statin if you’re at high risk for diabetes.’”

Nevertheless, Miller doesn’t dismiss his patients’ concerns.

“The customer is always right,” he says. “If a patient has side effects, I give them a statin holiday to see if the symptoms go away.”

Then he might try a different statin or a different dose. “I’ve had a lot of success using alternate-day therapy using statins that have a long half-life. I have some patients on a Monday-Wednes­day-Friday regimen.”

Clearly, Miller would prefer his patients to lower their risk with diet and exercise.

“If a patient has had a heart attack or stroke, or has peripheral artery disease, we really try to get them to go on a statin. But if somebody comes in with a mild elevation in LDL but no other risk factors, we try to get them to eat a good diet, increase their activity, and lose some weight if they’re overweight. Then they may not need a statin at all.”

But overall, statins’ risk of harm—and cost—are low.

“You always have to weigh the risk versus benefit,” says Miller. “But it’s rare in medicine that study after study shows a benefit of a drug, and the likelihood of it causing permanent damage in an otherwise healthy individual is exceedingly rare.”

Bottom Line: Statins are unlikely to cause serious, irreversible harm.

The information in this post first appeared in the May 2019 issue of Nutrition Action Healthletter.

llustration: adapted from JAMA 309: 1419, 2013. Photos: stock.adobe.com: Pineapple studio (burger), baibaz (milkshake), Gresei (cupcake), Matthew Benoit (pizza), gitusik (cookie), philip kinsey (breakfast sandwich), nerthuz (torso), 7activestudio (artery), ladysuzi (woman).

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