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Women and statins

When the drugs may not make sense

Published: June 2010

Background

In the U.S., about 13.5 percent of women 45 to 64 take a statin medication to reduce their cholesterol, such as atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Altoprev, Mevacor, and generic), pravastatin (Pravachol and generic), rosuvastatin (Crestor), and simvastatin (Zocor and generic). The assumption is that it will cut their risk of coronary artery disease and premature death. About 33 percent of women 65 and older take one for the same reason. Of those, estimates indicate that perhaps one million women 65 to 74—and potentially many more from 45 to 64—might want to take a closer look into whether or not a statin drug is a good choice.

There has been an almost 10-fold increase in the use of statins in the U.S. over the past decade by adults 45 years of age and older. Not surprisingly, drugs to lower cholesterol were the most popular medications in the U.S. in 2009. Last year more than $14 billion was spent on them, according to IMS Health. (One drug alone, Lipitor, had $7.5 billion in sales in 2009.)

For women with heart disease, using statin drugs reduces the chance they'll have a heart attack. But for some women—those who only have elevated LDL (or "bad" cholesterol levels) with a very low risk for cardiovascular disease—the benefit of statins should be weighed against the potential harm from taking them. 

What are the risks?

Side effects from statins can include constipation, diarrhea, gas, headaches, and joint pain. But a more potentially serious side effect is muscle pain and weakness—mild to severe cases occur in about 5 to 10 percent of all people who take a statin, although a recent survey found that the figure could be as high as 32 percent. And, higher doses have also been linked to an increased risk of a life-threatening form of muscle breakdown called rhabdomyolysis, which can lead to permanent kidney damage, coma, and even death. About one in 10,000 or fewer might develop that problem.

Other recent research utilizing the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey (NHANES) found that adults who took statins were 50 to 60 percent more likely to have pain in their lower back and lower extremities than adults who didn't use them.

Another concern is a slightly increased risk of diabetes. A recent large analysis of 13 statin studies published in the medical journal Lancet found that the drugs were associated with an increased risk of developing diabetes by 9 percent. (Diabetes increases your chances of having a heart attack, stroke, and other health problems.) In a group of men and women taking statins over four years, one additional person in 255 would develop diabetes. (But more research is needed to understand the specific cause.)

Other side effects and adverse events have been associated with statin use. A 2010 study that included a large-scale analysis of more than 225,000 patient records of men and women in the U.K. taking a statin found an increased risk of liver problems—especially during the first year of use—particularly true at higher doses for women. An estimated one in 100 people who take statins might develop abnormal liver-function tests—a sign of liver injury.

Increases in the risk of cataracts and acute kidney failure have also been associated with statins. Over the course of five years, in women with a medium risk of heart disease, an additional one in 40 treated with statins developed cataracts, one in 154 developed moderate or serious liver dysfunction, and one in 313 developed moderate or serious muscle weakness. One additional woman in 593 developed acute kidney failure.

Cognitive problems have also been associated with some statins. Other reported associations have included depression, severe irritability, and even cancer. All of these should be studied further. Women who are (or might become) pregnant should not take statins at all since there is proof that they can cause birth defects.

If you think you have experienced an adverse event with this drug or any drug, especially if it is of a serious nature, it is important to 1) tell your doctor immediately and 2) report the event to the Food and Drug Administration via the FDA's MedWatch website at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm or by calling 1-800-FDA-1088.


What are the benefits?

Probably as a result of the protective effect of estrogen, heart disease occurs in women 10 to 15 years later than it does in men. While many women over 45 take statins, some might have a low risk for cardiovascular disease. And being at low risk might make the risks of taking statins outweigh the benefits.

Understanding the benefits of statins for women at low risk hasn't been clear-cut. Some large studies on statin drugs have included significantly fewer women than men, and in some cases trial results were not initially broken down by gender. But analyses have looked at data from women without heart disease across a number of large trials. A study in the Journal of the American Medical Association found that in women without cardiovascular disease, the effect of statin therapy was not clear because of the relatively small number of events. But statin use did not appear to have a beneficial effect on "total mortality" for women with or without previous cardiovascular disease. (In other words, they did not—in general—live longer as a result of taking the drug.)

And a 2008 meta-analysis in the International Journal of Cardiology found that for both men and women without heart disease, using a statin appeared to have no effect on total mortality during the period of the trials (2.8 to 5.3 years). Another meta-analysis from the Archives of Internal Medicine from June 2010 had a similar finding: Even high-risk men and women without prior cardiovascular disease who took a statin did not appear to live longer during the trial years (an average of 3.7 years) than those who didn't take one.

One way to determine the benefit of treatment is to calculate the "number needed to treat"—how many people need to take the drug for so many years before one event—such as a heart attack, for example—is avoided. The U.K. study mentioned earlier calculated that for women at "medium" risk of cardiovascular disease, 44 would need to take a statin for five years to prevent one case of it. And the previously mentioned JAMA analysis estimated that 140 women who don't have cardiovascular disease would need to be treated to prevent one coronary heart disease event, such as a heart attack.

An exception to these findings has been a large-scale trial of men and women without high LDL cholesterol but who had elevated levels of a substance that indicates inflammation is present in the body, C-reactive protein. In the trial, called JUPITER ("Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin"), apparently healthy men and women were found to have significantly reduced rates of a first major cardiovascular event and death from any cause when taking rosuvastatin. (See our related story about this trial here.)

What you can do

Before you can attempt to lower your risk, you need to know what it is. People with multiple risk factors, such as having high blood pressure or diabetes, being a smoker, being sedentary, or having high LDL cholesterol, are among those with the highest risk for a heart attack.

With a goal of lowering your future risk of a heart attack, you need a clear answer to the question: What level of risk am I at right now? And how does lowering my cholesterol or changing other risk factors help reduce that overall risk?

Calculating your risk of a heart attack can be easily done with a cardiac risk calculator. The risk calculator from the National Cholesterol Education Program is a good place to start.

You'll need to know your total cholesterol level, your HDL or "good" cholesterol, and your systolic blood pressure number (the first number in the reading, for example the "140" in 140/90). With that, the tool will calculate your overall 10-year risk of heart attack.

The tool can also help determine how much your risk would change if you altered your cholesterol levels, reduced your systolic blood pressure or quit smoking. You might be surprised by how much quitting smoking alters your risk vs. something like altering your cholesterol levels. Some things you can't change, such as your family history, gender, or age, but reducing cardiovascular risk is about making lifestyle changes.

Lifestyle changes—they matter. It makes sense for women to be mindful of their heart health. If you are a woman who doesn't have any risk factors for heart disease, but you've learned that you have elevated levels of LDL cholesterol, there are several lifestyle changes that you can follow to help your health.

Stay active. Regular aerobic exercise protects against major cardiac risk factors. It can raise HDL levels and might help lower LDL cholesterol levels, reduce blood pressure, help control body weight, ease stress, and might reduce arterial inflammation. Strength training also improves heart-health, too, since building muscle also boosts your fat-burning capacity.

Eat a "heart healthy" diet. Consuming the right foods can protect your heart in several ways, including lowering LDL (bad) cholesterol and blood pressure levels, limiting inflammation of the arteries, warding off type 2 diabetes, and of course, helping you lose weight. See here for more detailed tips.

Lose excess weight if you need to, since doing so can also help to reduce LDL and blood pressure levels and keep type 2 diabetes at bay. Limiting portions, consuming fruits, vegetables, and whole grains, and even eating at home have all been shown to improve weight loss results.

Moderate alcohol consumption (up to one drink a day for women and two for men) can raise HDL cholesterol and possibly reduce inflammation. But even a little too much alcohol undermines the heart.

Keep stress in check. Negative emotions such as stress or anger trigger the release of hormones that can threaten your heart. And people who experience those emotions have more heart attacks than calmer, more cheerful types, research suggests.

Don't obsess about your numbers. But take your health seriously.

Bottom line

Research has found that for women with elevated LDL levels as their only coronary risk factor, the benefit of lowering LDL cholesterol with a statin drug might not outweigh the risks. Instead, one of the best ways for them to reduce their lifetime risk of heart attack or death is to follow healthy lifestyle practices. That said, some women and their doctors might decide to try a statin with the hope it will provide additional protection.

Editor's Note: These materials were made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by a multistate settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).
   

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