High-Dose Statin Drugs, When Pharmaceuticals Help, Head Lice Redux

• Letter to Our Readers
• High-Dose Statin Drugs - The Truth Behind the Headlines
• Rant O' the Month - When Pharmaceuticals Help
• The Doctor's Mailbox - Head Lice Redux
• Monroe Street Clinic News - Web Site Improvements

Letter to Our Readers

Last month we announced that in April we would present the "Sunshine Issue," a discussion of the risks and benefits of exposure to the sun. Instead I think it is more important to dedicate much of this issue to recently published claims for high-dose statin drugs. Many of my patients have been asking about these drugs, so this month I discuss and interpret the new research as it now stands. Next month I'll return to the issue of sunshine. By that time, there may actually be some.

High-Dose Statin Drugs - The Truth Behind the Headlnes

Statins are drugs that lower cholesterol. Recently, The New England Journal of Medicine published a study that showed high-dose statin therapy lowered the risk of heart disease more than did low-dose statins. An accompanying editorial hails this study as providing a "sea-change" in prevention of heart disease . The Washington Post was one of many newspapers extolling the results, stating that with high dose statins, the patient's chance of dying was "slashed by 28 percent." The article quoted a professor of cardiovascular disease saying, "It's a really, really important study."

Sounds pretty impressive, doesn't it? Does this mean that heart patients should start taking high-dose statins? The answer is, "that depends." It depends on your age, sex, cholesterol level, financial resources, and tolerance for side effects, and even on your philosophy of life. Let's take a closer look at what the study actually shows.

The Patients

The researchers enrolled people who had just been hospitalized with heart disease and were not candidates for coronary bypass. The average HDL ("good cholesterol") in the study group was 39, which is considerably below the national average. The patients averaged 58 years of age. They had an unusually high CRP level of 12.3. CRP (c-reactive protein) is an inflammatory protein; levels above three are associated with higher risk of heart disease, see our article in our November, 2002 newsletter.

The Study Protocol

Patients took either 40 milligrams of pravastatin (Zocor®) or 80 milligrams of atorvastatin (Lipitor®). They were observed for up to 30 months. Observation stopped when they reached what the researchers called an "end-point." End-points were death from any cause, heart attack, or hospitalization for angina, cardiac surgery, or stroke.

To be fair, we'll note the investigators took many measures to eliminate bias including the following.

1. People with a total cholesterol of over 240 were eliminated from the study, in order to study a more representative group of patients.

2. If a person had to discontinue a statin due to side-effects, they were still considered as part of the treatment group. This leads to an understatement of the effect of the drug, but more fairly evaluates the results of a decision to start high-dose statin therapy.

The Results

By the end of the study, 22 percent of the high-dose group had died or suffered further heart disease compared to 26 percent in the low-dose group. This means that four people in a hundred benefited from taking the higher dose. A reduction from 26 percent to 22 percent is a 16 percent reduction, so researchers and the media reported that heart disease was "reduced 16 percent."

In the high-dose group, 1.1 percent died from heart disease, compared with 1.4 percent in the low-dose group. Considering all deaths, and not just those from heart disease, 2.2 percent died in the high-dose group compared to 3.2 percent in the low-dose group. This is, of course, a wonderful result for that one person in a hundred whose life was saved by taking a statin. And since the number 2.2 is 28 percent less than the number 3.2, researchers and the media reported a 28 percent reduction in death rate from taking the statin.

The CRP was lowered from 12.3 to 1.3 in the atorvastatin group. That may explain part of the decreased death from causes other than heart disease. Statins may have other effects besides lowering cholesterol. However, the aspect of the study that looked at stroke showed that high-dose statin did not differ from low-dose statin as far as stroke rates were concerned.

Who Benefited

People who had an LDL (the "bad cholesterol") of 125 or more experienced a 34 percent reduction in heart disease and death, compared to 7 percent for people with an LDL below 125. Women experienced more benefit than men. However, older patients and people who had taken statins before the study started benefited less.

Taking everything into account, here's a fair statement of the results of this test: People who had been hospitalized with heart disease -- a group with lower levels of the beneficial HDL cholesterol and higher levels of the inflammatory risk marker CRP than the usual person on the street -- had improved health (as measured by heart disease and death rates) when given high doses of atorvastatin as compared to a moderate dose of pravastatin. The drug probably has beneficial effects in addition to lowering cholesterol levels. What happens after 30 months is still under investigation.

The Downsides of Statins

Statins have side-effects, the most serious of which is called rhabdomyolysis, a condition in which muscle tissue degenerates. The bad news is that this is frequently fatal; the good news is that it doesn't happen very often. To see the statistics click here.

Statins can damage the liver. Most doctors require liver function tests on people taking statins to check for liver damage. The liver changes usually return to normal when the statin is discontinued.

Many people taking statins complain that although they like the lower cholesterol, they hate the myalgia, or muscle pain. The pain makes them uncomfortable enough that they stop their statin. In this study after two years, 30 percent of the patients, even in the low-dose group, had discontinued the statin because of side-effects, personal preference, or other reasons. Although these researchers report that only 3 percent discontinued because of myalgia, that does not reflect my experience. A considerably higher percentage of my patients say they suffer from some degree of muscle discomfort.

Taking statins along with other cholesterol-lowering drugs, such as gemfibrozil, increases the risk of side effects.

Finally, statins are not cheap. An 80 milligrams dose of atorvastatin costs $1400 per year versus $900 per year for 10 milligrams of the drug. Some people save money on statins by taking a lower dose along with grapefruit juice. Grapefruit juice slows the body's clearance of statins, but can also increase the risk of side effects, especially with large doses of statins. I would NOT recommend this strategy without physician supervision.

The Commercial Thumb on the Scale

Ideally, medical research would be conducted by people with no financial interest in the outcome. With reduced public funding of research, that ideal has become more of a dream than a reality. Investigators attract the millions of dollars needed to do studies in several ways. One way is to give the study a catchy title. This study was titled "PROVE-IT" and followed previous statin studies with names like "REVERSAL" and "MIRACLE." Another way is to lecture or consult for pharmaceutical companies. Two authors of this study work for and own stock in the company that makes one of the statins studied, and other authors consult for this and other statin producing companies. Eric Topol, the author of the editorial mentioned at the beginning of this article, consults for and has received grant money from Bristol-Myers Squibb (maker of pravastatin), and Pfizer (maker of atorvastatin).

Summary

This study shows improved health and longevity for some people when they take higher doses of statins. The people most likely to benefit are those who have been hospitalized for heart disease, especially if they are women, are younger, have not previously taken statins, and have an LDL cholesterol greater than 125. Within this study group, older people, men, and those with lower LDL levels benefited less.

For an individual with heart disease severe enough to have required a hospital visit, high-dose atorvastatin will buy a one in 25 chance of not suffering heart disease during the next two year period, and a one in 100 chance of not dying, when compared with a moderate dose of pravastatin.

More Information

For information about cholesterol, we have a program that runs occasionally on the local cable television channel, PTTV. You can also see or borrow this videotape from our office.

For information about taking niacin to lower cholesterol, go, to our September, 2003 newsletter.

To get an online estimate of your risk of death from heart disease, go to our January, 2002 newsletter.

Rant o' the Month - When Pharmaceuticals Help

As you see from the preceding, I look at pharmaceutical agents with a critical eye. A critical eye sees benefits as well as risks. Recently I've been thinking about opiate-containing pain medication. Every week someone comes in with some viral illness with muscle aches so severe that they can't sleep at night. And so their illness goes on day after day. I suggest some acetaminophen (Tylenol®) with codeine to eliminate the pain and get them some sleep. "No, doc," the patient says. "I don't want to mask the symptoms, I want to get well on my own."

That's a good thought, but you will get well on your own more rapidly if you get some rest. During that respite, your immune system will finally be able to do its job and help you get well. We have tremendous healing powers within. They don't do so well when we are stressed with pain and full of adrenaline. When we are resting, even if we need a powerful drug to do so, these healing systems work much more effectively!

Letter to Editor

Dear Dr. Rienstra:

I found your article on head lice very interesting as both of the grandkids like to share. We had just had a bout with it when your newsletter arrived. I went looking online and found that the head-lice remedy you recommended is available in the USA as Hair Clean 1-2-3 at Quantum Health.

--A Reader

Our Reply

In our January 2004 newsletter, we reported that a natural remedy containing coconut oil, anise oil, and ylang ylang oil commonly used in Israel, achieved better results than pharmaceuticals. Although we do not usually recommend specific brands, some of our readers will appreciate knowing about this source. Thanks for your sleuthing.

Monroe Street Clinic News

Wind's Eye Design has helped us upgrade our website. The new design makes access to health information quick and easy. In addition to information about the clinic, the site contains archives of our newsletters with full article text date back to 1999.