New study yields important information, but stops short.
Find out why this study is important and informative, but shouldn’t be used as an excuse to put millions more people on statin drugs.
Older people with high levels of C-reactive protein (CRP) who took the statin drug Crestor appeared to dramatically reduce their risk of heart disease and death, according to a newly released study, known as the JUPITER study, sponsored by the maker of the statin drug Crestor, and published in the New England Journal of Medicine (Nov 6, 2008). CRP is made in the liver in response to inflammation, and is a very useful marker for heart disease. A CRP test should be included in any heart health assessment.
JUPITER study participants were “apparently healthy” older adults except for higher-than-normal CRP levels.
Inflammation Contributes to Heart Disease
This is an important study that adds to the increasing evidence that inflammation plays a major role in heart disease. It also suggests that inflammation may be the issue in people with heart disease who had no other conventional risk factors such as high cholesterol and blood pressure. Inflammation may also be a key to what causes heart attacks in those with a family history of heart disease but few other conventional risk factors. What this study does not do is confirm that Crestor in particular, or statins in general, are the safest or most effective way to lower CRP levels. There’s no doubt that statins do lower CRP, but it may be like using a chain saw when a butter knife will do the job.
A Closer Look at the CRP and Statins Study
The study, which was planned to go on for five years, stopped at two years, presumably because the results were so dramatic that statin drugs couldn’t be withheld from those in the placebo group. On the other hand, a lot of important questions still need to be answered, none of which can be in a two-year study.
For example, none of the study participants had diabetes when the study began. When the study ended, more people in the Crestor group had been diagnosed with diabetes. Had diabetes been an “end point” in the study, as were heart attack, stroke, angina, and revascularization (e.g. bypass surgery), the end result would not have been anywhere near as dramatic—averaged out, the Crestor and the placebo groups would have looked a lot more similar. Considering that diabetes is one of the biggest risk factors for heart disease, perhaps new onset of diabetes should have been included.
When the study began, none of the patients had high cholesterol levels. When the study ended, almost everyone in the Crestor group had much lower cholesterol levels. Previous studies have shown that, especially for older women, low cholesterol levels increase the risk of cancer, liver disease, depression and mental illness. Since most cancers and liver disease take more than two years to develop, this study was stopped before either could have been detected. Measures of depression and mental illness were not included.
One of the most significant pieces of this study is that within individual health characteristics in the Crestor group (e.g. obesity, metabolic syndrome, blood pressure, smoking), those with a family history of coronary heart disease (CHD) were by far the group most helped by Crestor. Benefits were modest or absent in all other groups except this one, which pulled the Crestor group average up.
Individuals with metabolic syndrome did better with the placebo than with Crestor. Metabolic syndrome describes an obese person with central or abdominal obesity (a fat stomach) who also tends to have a poor cholesterol profile, high blood sugar and insulin and the attendant insulin resistance, high blood pressure, and clogged arteries. In other words, diabetes and/or heart disease waiting to happen.
Lots of Significance but Very Small Numbers
Another perspective on this study is that the “primary end point” for the study (what researchers were looking for) was a “first major cardiovascular event” and “death from any cause.” However, out of the 17,802 participants, there were only 142 in the Crestor group and 251 in the placebo group who qualified for the primary end point at the end of the study. Although that’s a highly significant percent difference, it’s a very small group.
Buyer be Aware – Statins are Not All the Same
This study was done with Crestor (rosuvastatin), but the makers of the other statin drugs are quickly jumping on the CRP-lowering bandwagon. Be aware—statin drugs are not all created equal. Some have significantly different side effects than others. The watchdog group Public Citizen has actually petitioned the FDA to ban Crestor because of concerns about rhabdomyolysis (a muscle disease) and kidney toxicity. According to Public Citizen, some of the major U.S. health insurers have refused to reimburse for Crestor because of safety concerns. Given the known toxicity of Crestor to the muscles and kidneys, I found it troubling that symptoms of muscle weakness and kidney function were reported to be about the same in both groups.
Lovastatin (Mevacor, Altocor, Altoprev) is among the safest of the statin drugs, probably because it’s the active ingredient in red yeast rice, the original natural statin.
CRP is a Marker, Not a Cause of Heart Disease
There has been plenty of evidence published in medical journals over the past decade or so, showing that CRP is a more important indicator of heart disease than cholesterol levels. In 2005 the New England Journal of Medicine published two articles showing that high levels of inflammation in the body, as measured by a CRP blood test, were as important as high levels of LDL (bad) cholesterol in promoting hardening of the arteries.
This current study certainly lends more strength to that argument, but it’s highly debatable whether long term statin use is the best way to treat high CRP levels.
A high CRP level is not a cause of heart disease, it’s a symptom, or marker of inflammation. Chronic inflammation plays a major role in making the kind of plaque that can break away from an artery and cause a heart attack or stroke.
What Raises CRP Levels
Here are some of the factors that can raise CRP levels: infection, obesity, smoking, high blood pressure, cancer, autoimmune disease, low antioxidants, excess estrogen, excess iron, omega-3 oils deficiency, high insulin, high blood sugar, gum disease, stress, lack of sleep, colds and flus, chronic pain, and allergies.
What Lowers CRP Levels
Here are some things that can lower CRP levels: losing weight, stopping smoking, good oral hygiene, reducing stress, a wholesome diet (especially plenty of fruits and vegetables), exercise, restful sleep and hormone balance. Sound familiar?
Think Twice Before Jumping on the Statin Bandwagon
What bothers me is that this study is going to be used as an excuse to put everyone with elevated CRP levels on statin drugs for life, even though we already know with certainty that long term, statin drugs can do as much harm as good, and that basic lifestyle changes can achieve the same goals over time. Statins are also expensive.
There’s a good chance that statins could really help those with truly hereditary heart disease (not just inherited unhealthy lifestyles) that predisposes to chronic inflammation and high CRP. But will statins just help for a few years? Are they safe and effective long term? These are important questions to be answered long before millions more people are prescribed statin drugs.
When educating and supporting patients to create and maintain a healthy lifestyle becomes a mandate for our health care system, billions of dollars and tens of thousands of lives will be saved every year.
Further Resources and Related Articles
Find out More about What Causes Inflammation and How to Douse It
Here’s an article on prostate health with a detailed section on inflammation that applies to everyone suffering from chronic inflammation: Update on the Prostate
Test Your CRP Levels: You can test your own CRP with this easy-to-use test kit.