Lipitor and other statin drugs are among the most commonly prescribed drugs in the United States.
Lipitor and other statin drugs are among the most commonly prescribed drugs in the United States. Mel Evans/AP
With one-quarter of adults over age 45 taking cholesterol-lowering statin drugs, it figures that more than a few people would have trouble sticking with the program.
More than a few, actually.
A big new study of statin use in the real world found that 17 percent of patients taking the pills reported side effects, including muscle pain, nausea, and problems with their liver or nervous system.
That's a lot higher than the 5 to 10 percent reported in the randomized controlled trials that provided evidence for regulatory approval of the medicines.
This study, which was published in Annals of Internal Medicine, looked at more than 100,000 people who'd been prescribed statins from 2000 through 2008 at two academic medical centers.
About two-thirds of people with side effects quit taking statins. All in all, half of all the people who been prescribed the drugs quit them at last temporarily. Twenty percent quit for more than a year.
It's tough to get people to take medicine to reduce the odds of disease years from now, notes Dr. Scott Grundy, a cholesterol researcher at UT Southwestern Medical Center in Dallas. "The vast majority of people don't have side effects," he wrote in an editorial accompanying the study. "Not continuing the drug has a lot more to do with people just not wanting to take drugs for a lifetime."
People have decidedly mixed feelings about the side effects associated with statins, according to a 2012 NPR-Truven Health Analytics poll.
The worry, of course, is that the ranks of statin quitters include people at high risk of heart disease, for whom the daily dose of cholesterol-lowering drug can reduce the risk of deadly heart attacks.
"Statins are important drugs, especially for patients with known heart disease," says Dr. Alexander Turchin, an assistant professor of medicine at Harvard Medical School, who led the study. "These are not drugs you just want to throw away without a second thought."
And many of the people in this study who quit the drug were able to get back on statins, Turchin and his colleagues found. Reasons varied.
"The side effects might have been tolerable," he told Shots. "They could have been specific to a particular drug that wouldn't arise with a different statin. Or they might not have been due to a statin at all. I had a patient with shoulder pain that we thought might have been due to a statin, but it turned out to be lymphoma."
But patients should still proceed with caution when considering statins, says Dr. Barbara Roberts, director of the Women's Cardiac Center at Miriam Hospital in Rhode Island, and author of a book called The Truth About Statins.
Studies haven't shown that statins help women who don't already have heart disease, even if they have risk factors like obesity and family history, she says. That's compared to a recent study that found a 30 percent reduction in heart attacks in people who follow a Mediterranean diet. "You can get just as much benefit from following the Mediterranean diet as you can from statins," she says.
Last year the Food and Drug Administration warned that taking statins slightly increases the risk of diabetes, even in people at a healthy weight and with no other risk factors. No research has been done to see if the diabetes goes away when patients stop taking statins, she says.
And long-term statin use may cause nerve damage, Roberts says. That damage often reverses, she says, but the process can take months. "I have two patients who wound up bedridden from biopsy-proven neuropathy due to statins; both improved but never returned to normal strength."
People should know their risk factors for heart disease, like smoking or a family history, and know their target level for LDL cholesterol. "A lot of primary care doctors and even some cardiologists don't know what the current prevention guidelines are," Roberts says, and may try to lower patient's cholesterol needlessly.
This calculator based on the Framingham Risk Score can help with that mission.
"I had a patient in her 90s, her LDL [low-density lipoprotein, the "bad" cholesterol] was 167," Roberts says. "Her doctor wanted to put her on a statin. She's now 104. She hasn't been on a statin, and she still doesn't have heart disease."