Right now the cholesterol-lowering drug Lipitor (atorvastatin) is the largest selling prescription medication in America, out in front of antidepressants, anti-heartburn agents, and pills for high blood pressure. Yes, many Americans do have high cholesterol, which is a risk factor for heart disease. And the advent 7 years ago of Lipitor and its statin cousins Zocor (simvastatin), Mevacor (lovastatin), Pravachol (pravastatin), and Lescol (fluvastatin) has been a boon for heart attack and stroke prevention. They’re powerful agents that can lower cholesterol—and associated heart disease risk—by as much as a third. But are statins truly necessary for most of the millions of people for whom they’re prescribed? Could lifestyle changes do the trick for them instead? After all, these drugs, like any other, have downsides.
For perspective on the matter, we turned to Ernst Schaefer, MD, a heart disease researcher who heads the Lipid and Heart Disease Prevention Program at the Tufts-New England Medical Center.
Q: Do you feel statins are being over-prescribed?
Dr. Schaefer: I think it works both ways. There are a lot of people who have heart disease or are at very high risk for it who aren’t getting treated adequately. On the other hand, I have seen a number of patients, especially elderly people, who don’t really have any risk factors other than high LDL [“bad”] cholesterol being treated extremely aggressively with drugs when some lifestyle measures could bring things into line. Dietary changes to bring down cholesterol get short shrift. Also, some people are told to take statins to lower their cholesterol when a statin won’t do them any good.
Q: What do you mean?
Dr. Schaefer: About 5 to 10 percent of the patients who are referred to my clinic for high cholesterol have an underactive thyroid, which is a rather common cause of high cholesterol in itself. Usually, they’re elderly people, often women. And their thyroid condition frequently isn’t picked up at their doctor’s office.
To lower their cholesterol, they’re prescribed a statin, or they try some dietary changes, and it doesn’t work, and they end up at my clinic because the case is seen as intractable. We check their thyroid as a matter of course. When an underactive thyroid is diagnosed, patients are given thyroid hormone, and the cholesterol comes down to the healthy range. They also feel a lot better all of a sudden. They feel less fatigued, have more energy, tolerate cold better, and move their bowels better; an underactive thyroid tends to make a person constipated. Also, problems a thyroid patient may have had tolerating the statin drug resolve themselves.
Q: How so?
Dr. Schaefer: Statins cause muscle aches and pains in 4 to 5 percent of people who try them. As many as 15 to 20 percent of people with an under-active thyroid who mistakenly take statins end up with muscles that hurt. You feel it all over—arms, legs, chest.
Sometimes the muscle aches and pains will get better on their own. But sometimes they get worse and worse. In extremely rare cases, muscle actually starts to break down severely, the muscle proteins go to the kidney to be filtered from the body, the kidney starts really sludging up, and the patient can go into kidney failure. It’s too much broken-down muscle for the kidneys to filter. The effects on muscle are especially a problem in older people.
Q: If you need to be on a statin yet have the muscle aches, what can your doctor do for you?
Dr. Schaefer: It’s a bit of trial and error. Perhaps lower the dosage. Perhaps switch you to another statin. Pravastatin affects the muscles less than other statins, but it’s also less effective at lowering cholesterol. There’s also a new drug called ezetimibe [Zetia], which blocks cholesterol absorption rather than stops cholesterol production, like statins do. It’s not as effective as statins, but it’s another option.
Q: Are there any other potential downsides to taking statin drugs?
Dr. Schaefer: There’s the potential of reversible liver enzyme elevation. Most of the time it doesn’t appear to have any practical significance. Most people, you put them on a lower dose of the statin or switch the statin, and the elevation in liver enzymes reverses itself. But very, very rarely—maybe in less than one in 1,000—someone can have very high liver enzyme elevations and feel pretty sick. There’s severe liver inflammation, the liver isn’t working properly, and there may be a marked loss of appetite.
Q: You said earlier that dietary changes to lower cholesterol get short shrift. Can you elaborate?
Dr. Schaefer: There have been well-done studies showing that if a doctor gives you a pamphlet with lists of low-fat foods and such, that doesn’t work. What I do in my clinic also doesn’t work very well much of the time. One or two visits with a dietitian—quite frankly, it’s frequently not enough. People don’t lose weight, which is one of the factors elevating the cholesterol, and they don’t get their cholesterol down. Unfortunately, a couple of visits with a dietitian is all that insurance companies often cover.
Q: What would work?
Dr. Schaefer: The only way for dietary change to really work is if people do it in some kind of classroom approach or group approach, and if they do it repeatedly—keep attending meetings. There was something called the Diabetes Prevention Project, where people who were overweight or otherwise at high risk for diabetes were in a program where they went to 16 classes and were really taught how to monitor their food intake, how to change their diets forever, and how to exercise more. It’s really like a course. People have to be committed to make the change, and you can’t expect them to do this in one or two sessions when for most other things we learn about as adults, it takes time, and it has to be repeated and repeated and repeated again. Especially because you’re talking about breaking habits built up over a lifetime. I’ve seen a lot of success in group approaches that are a little more intensive, like when people go to Weight Watchers.
Q: Can doctors do anything to change the way things are handled?
Dr. Schaefer: I think it’s difficult for doctors because they don’t have a lot of time. They’re trained to diagnose things and give people pills. They’re not really trained to do nutrition. So often it’s the consumer, the patient, who has to find a program in the community that helps get the weight off and gets the ball rolling with exercise. Not that weight is always the issue, but often it is.
Q: Can someone with high cholesterol really get it down by cutting out excess calories and saturated fat and getting more exercise? Can it really be as effective as drugs?
Dr. Schaefer: Absolutely. Of course, cholesterol is determined by genetics as well as lifestyle. There are some people that no matter how hard they try, diet alone isn’t going to do it. And they may feel very frustrated by that. But diet, exercise, and medications are not mutually exclusive. People should take advantage of both diet and drugs if their doctor tells them to go on a statin once they’ve given lifestyle change an honest effort. The statins have been shown to reduce heart disease very substantially.
Q: And then do you stop worrying about lifestyle?
Dr. Schaefer: No. The lifestyle changes are still very important. People can eat their way around a statin. I’ve seen people on terrible diets whose cholesterol levels were hard to control with statins, even though those drugs are very effective.
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