It's an all too common scenario: A 60-year-old woman is told she has high cholesterol but has no other risk factors for heart disease like high blood pressure, diabetes, or a smoking habit. Should she take a statin to lower her cholesterol?
Many doctors say, why not? But a review study by the well-respected Cochrane Colloboration, a nonprofit research organization, suggests otherwise. The review, which analyzed 14 trials involving the use of statins to prevent heart disease in low-risk patients, found only "limited evidence" that the drugs provide significant benefits, especially in women, and urged that "caution should be taken when prescribing statins" to prevent heart disease.
The cholesterol-lowering drugs -- which include atorvastatin (Lipitor), rosuvastatin (Crestor), and simvastatin (Zocor) -- have clearly been shown to reduce heart attacks, strokes, and deaths in higher risk patients such as those with diabetes or established heart disease. And they have minimal side effects, which makes them appealing to prescribe even in those who have, say, less than a 10 percent risk of having a heart attack in the next 10 years.
In fact, the American Heart Association recommends that low-risk patients with high cholesterol consider taking a statin if lifestyle changes, such as increased exercise or weight loss, don't work to bring cholesterol levels down.
But the Cochrane review study -- written by British researchers -- calls that practice into question, highlighting "shortcomings" in studies that found clear benefits in anyone who took statins to lower high cholesterol levels.
"The potential adverse effects of statins among people at low risk of [cardiovascular disease] CVD are poorly reported and unclear," the authors wrote. They add that the inclusion of those with established heart disease and high insulin levels (pre-diabetes) makes it tough to determine how big the benefits truly are for those at low heart risk.
Other experts, though, disagree. "I think they make grand pronouncements that are wrong," says Chris Cannon, a cardiologist at Brigham and Women's Hospital who participated in a recent review study of statin use in low-risk patients published in the November issue of Lancet. (Cannon has accepted research grants from statin manufacturers and served on an advisory board for Bristol-Myers Squibb, which makes the statin Pravachol.)
The Lancet study found that both high-risk and low-risk patients who take statins to lower their cholesterol levels are able to reduce their risk of having a heart attack, stroke or heart procedure by 25 percent.
In absolute risk terms, statin users who don't have heart disease would lower their yearly risk of having heart complications from 1.8 percent to 1.4 percent. Those who have already been diagnosed with heart disease would lower their yearly risk from 5.6 percent to 4.5 percent -- and those with type 2 diabetes from about 5 percent to about 4 percent.
Clearly, the lower your heart disease risk, the smaller the benefits you'll receive from statins. That means the risk of side effects will probably play a greater role in determining whether you should take the drug. The Cochrane report found that statins didn't increase the risk of cancer and posed only a tiny risk of rhabdomyolysis, a serious condition involving the break down of muscles.
The biggest side effect, severe muscle soreness, occurs in about 3 to 5 percent of users, though some research indicates the incidence may be higher in women and for those who take higher doses or more potent statins. Cannon, though, says 80 percent of the time, he can alleviate this symptom in his patients simply by switching them to another statin.
Researchers are also investigating whether statins cause cognitive decline in some users, and no one knows the health ramifications of taking statins for decades, because the longest studies so far extend to only 15 years.
Experts agree, though, that statins are very safe drugs and very necessary for those with heart disease, diabetes or multiple heart disease risk factors, including high blood pressure, high cholesterol, and a family history.
Cannon says he worries that this new "headline-grabbing" study will lead some high-risk heart patients to stop taking their statins. "While we shouldn't put everyone under the sun on statins, these drugs are clearly the best thing we have in cardiovascular medicine."
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