Little Cause For Excitement With JUPITER Study

There was great excitement at the annual American Heart Association (AHA) 2008 Scientific Sessions beginning with a bang at the release of data from the new JUPITER study. Headlines are blazing across the media that say, “Heart Attack Risk Lowered More that 50% By Taking Crestor,” a statin drug made by AstraZenica.

Before anyone rushes to add statin drugs to lower the risk of heart attacks when their heart shows no sign of disease, let’s take a close look at the findings for they reveal a more important discovery, one I saw in 5,000 heart surgery patients—inflammation, which is the real cause of heart disease.

The study intended to assess whether statin therapy should be given to apparently healthy individuals with normal LDL cholesterols but elevated C-reactive protein levels (CRP 2.0 mg/L). A C-reactive protein is a marker that determines the level of inflammation in the body. AstraZenica, the manufacturer of Crestor, funded the study when Pfizer declined to do so.
To qualify for the study patients had to be apparently healthy, have normal cholesterol but have an elevated CRP. Over 1.9 years, 17,802 patients were treated—men over 60 and women over 50 with one-half receiving 20 mg. of Crestor daily and the other half receiving a placebo.

As many noted after release of the findings, even though the patients were classified as healthy, many had a number of cardiovascular risk factors—overweight with the median body-mass index (BMI) of 28.3 kg/m2. It would be unfair to say these patients had no other risk factors. Very few individuals have ideal risk factors, including LDL-cholesterol levels. Many have suggested ideal LDL-cholesterol levels, based on hunter-gatherer societies and non-human primates are likely in the range of 50 to 60 mg/dL.

The benefit to treatment of patients as well as any changes to public-health policy depends on the absolute benefit and not the relative risk reduction. This is very important in assessing the significance of the results. The risk of having a heart attack in the placebo group was 1.8%. The risk in the group treated with Crestor was .09% for a real reduction of .9% also called the absolute risk deduction. While this is a 50% reduction in relative risk, the actual real difference is less than 1%.

Of great importance, despite headlines blazing across the internet, media, radio and news stations attesting to the magnificence of the findings, only one person out of 120 patients treated over 1.9 years avoided a heart attack. If it takes treating 120 people with a drug to prevent one heart attack, there is very little in this study to generate this much excitement or use statin therapy preventatively—unless you are the drug company anticipating astronomical sales.

Dr. Mark Hlatky, reporting in the New England Journal of Medicine, wrote, “The relative risk reductions achieved with the use of statin therapy in JUPITER were clearly significant. However, absolute differences in risk are more clinically important than relative reductions in risk in deciding whether to recommend drug therapy, since the absolute benefits of treatment must be large enough to justify the associated risks and costs. The proportion of participants with hard cardiac events in JUPITER was reduced from 1.8% (157 of 8901 subjects) in the placebo group to 0.9% (83 of the 8901 subjects) in the rosuvastatin group; thus, 120 participants were treated for 1.9 years to prevent one event.”

The cost for treating 120 people with Crestor is $3.45 a day or $302,220.00 for two years, an exorbitant amount of money to avoid one heart attack. In addition to this cost, there would be the cost of 2,880 doctor’s visits with 2,880 cholesterol tests. What JUPITER revealed is, only one person avoided a heart attack and there were significant side effects in the increase in people who developed diabetes and other complications.

The patients all began with normal cholesterol and markers for inflammation. The finding in the study that has far more significance is the reduction shown in inflammation. Cholesterol in the patients began within the normal range so reducing it further is not the reason there was a small reduction in risk; rather, the reduction in inflammation was accountable for the small difference in heart attack rates.

Now, I am all in favor of prevention and do not want anyone to have a heart attack but once again, medicine, under the influence of drug companies, takes the wrong and most expensive approach. AstraZenica stock is up 45% since the news and they expect to double the sales of Crestor from 3 billion to 6 billion dollars annually in the next few years—great news if you hold the stock, not so great for really preventing heart disease or controlling costs of health care.

If Astra were honest, they would ask the FDA for permission to market Crestor as an anti-inflammatory for the blood vessels—a much better use of statin drugs but expensive. Although this study showed only a small benefit, it does re-confirm that inflammation is the cause of heart disease. The cholesterol theory, while exceedingly false, is the dogma of the day and it is time for truth and fact in medicine.

There are alternatives to statin therapy to reduce inflammation and in turn, prevent and cure heart disease—alternatives that do not involve drug therapy and yet have a higher absolute reduction in cardiac deaths. The medical community fails to acknowledge the simple alternatives that are much more effective than drugs, less remunerative of course, but with astounding reductions in cardiac deaths through treating inflammation.

The DART trial showed a 62% reduction in cardiac deaths by taking fish oil. Fish oil has proven repeatedly to reduce CRP and other signs of inflammation. Another trial, The Physicians Healthy Study showed a 90% reduction in sudden cardiac death with fish oil; once again, not risk but actual reduction. Another, the GISSI trial, showed an absolute reduction in deaths by taking fish oil and a 47% reduction in sudden cardiac deaths. These are not risk numbers but real reductions.

The most significant and overlooked results of the JUPITER study that confirms the findings in DART, GISSI and The Physicians Health Study is that the reduction in inflammation was responsible for decreasing the risk of heart disease. The patients’ all had normal cholesterol when the study began; reduction in cholesterol was not responsible for the small decrease in risk.

As a physician who performed 5,000 heart surgeries and saw inflammation in the arteries of every patient, it is maddening when medicine ignores simple things such as fish oil that are much more effective than drugs. In terms of cost, the simple alternatives that are highly effective range from $50 to $100 per month.

There is no comparison to health, or to the wallet, in terms of these alternatives and the exorbitant cost of statin therapy for cholesterol when cholesterol is not the cause of heart disease. However, it is noteworthy there is a benefit to statin therapy in that it has some impact upon inflammation but at a much higher cost than fish oil.
Treat inflammation and the absolute risk of heart disease not only decreases, heart disease is preventable and curable.

To learn how to control inflammation, prevent and cure heart disease, get a copy of my new book, “The Great Cholesterol Lie: Why inflammation Kills and the Real Cause of Heart Disease.” You can fight the fires of inflammation through simple changes in the foods you eat, adding Omega-3 and other supplements recommended in the book.

Dr. Dwight LundellPhoenix, AZ