A New Women’s Issue: StatinsMedical guidelines issued late last year may double the number of Americans who are told to take these cholesterol-lowering drugs. But the recommendations don’t distinguish patients by gender, and a small, increasingly vocal group of cardiologists believe that’s a mistake.
Far too many healthy women are taking statins, they say, though some research indicates the drugs will do them little good and may be more likely to cause serious side effects in women.
“If you’re going to tell a healthy person to take a medicine every day for the rest of their life, you should have really good data that it’s going to make them better off,” said Dr. Rita Redberg, a cardiologist at the University of California, San Francisco, and the editor of JAMA Internal Medicine. Lowering cholesterol should not be not an end in itself, she added, and cholesterol may not play the same role in heart disease in women as in men. “You can have high cholesterol and still be really healthy and have a low risk of heart disease,” she said.
Although women represent slightly more than half of the population, they have been vastly underrepresented in clinical trials of statins. As a result, evidence on the benefits and risks for women is limited.
Women tend to develop heart disease about 10 years later in life on average than men; women’s risk begins to equal that of men when they reach their mid-70s.
Studies have found that healthy women who took statins to prevent cardiovascular disease did experience fewer episodes of chest painand had fewer treatments like stents and bypass surgery. But statins didn’t prevent healthy women from having their first heart attacks and didn’t save lives.
The Jupiter trial, which included 6,801 women age 60 and older, found a significantly lower risk of so-called soft endpoints, like hospitalization for unstable angina, among healthy women taking statins.
But the absolute number of these health setbacks was small, and there was no significant reduction in heart attacks, strokes and deaths among these women. By contrast, male participants on statins had significantly fewer heart attacks and strokes.
“The data are underwhelming, to say the least,” said Dr. Barbara Roberts, author of “The Truth About Statins: Risks and Alternatives to Cholesterol-Lowering Drugs” and an associate professor of medicine at Brown University. “Women who are healthy derive no benefit from statins, and even those women who have established heart disease derive only half the benefit men do.”
Dr. C. Noel Bairey Merz, director of the Barbra Streisand Women’s Heart Center at the Cedars-Sinai Heart Institute in Los Angeles, disagreed. “We haven’t shown that we can prevent deaths, because we just haven’t enrolled enough women, and that’s a crime,” she said. “But the absence of data is not the same as negative data.”
In the meantime, she said, “we can either sit on our hands or use our best judgment to make an educated guess, and can decide to treat.” (Dr. Bairey Merz has had financial relationships with drug companies, including Abbott Vascular, Bristol-Myers Squibb and Gilead.)
The debate has taken on added urgency because of the risks associated with statins, which often are supposed to be taken daily for the rest of one’s life. The drugs have long been known to causemuscle pain in some people and, more rarely, liver and kidney damage, as well as cognitive side effects like memory loss and confusion.
In 2010, Johns Hopkins researchers discovered that statins could, in rare instances, make the body produce antibodies against its own proteins, engendering a painful and debilitating muscle disease that actually gets worse when patients stop taking the drugs. But the most common side effect is diabetes.
In 2012, researchers published a study showing that postmenopausal women who took part in the Women’s Health Initiative were much more likely to develop diabetes if they took statins, and diabetes itself increases the risk of heart disease considerably.
Despite the concerns, women are heavy users of statins, especially in midlife — when the gap in heart disease risk between men and women happens to be greatest. Some 16 percent of women ages 45 to 64 take statins, compared with 18 percent of men.
Over all, 26.9 percent of men 45 and over take statins, compared with 23.6 percent of women, though significantly more elderly men than elderly women use statins.
Even critics of statin use in healthy women say they would not hesitate to prescribe the drugs to patients with established heart disease. But since cholesterol readings are increasingly used as quality indicators to rate physicians and health plans, many younger adult women may feel pressured to take the medicine even though they are in good health, some doctors say.
“I have women come to me who were put on statins in their 30s by their physician because their cholesterol was a point or two above what’s said to be normal,” Dr. Roberts said. “This is insane.”
But some healthy younger women certainly will go on to develop cardiovascular disease, Dr. Bairey Merz said, and statins may help prevent it. “I’m driving in my car, I’m perfectly healthy. Why do I have my seatbelt on?” she asked.
To some extent, the differences represent different philosophies.
Although the new treatment guidelines recommend lifestyle changes for lowering cholesterol, Dr. Bairey Merz said: “I think they should probably go out the window. We have yet to find any kind of lifestyle change intervention that actually helps people live longer.”
But Dr. Roberts advises women that they can reduce their heart risk by watching their weight, exercising and following a diet rich in fish, fruits and vegetables, nuts and olive oil — and, if they’ve never had heart trouble, forgetting statins.
“We know you can get the benefit and relative risk reduction from adhering to a Mediterranean-style diet,” she said.