Science Based Wellness

About JUPITER

Recall that JUPITER is an acronym for “Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin.” The JUPITER trials were intended to justify the use of a class of cholesterol lowering medications known as statins on apparently healthy patients who had:

• Normal cholesterol levels (They did not need cholesterol lowering medication)
• Elevated levels of c-reactive protein (CRP) indicating the prevalence of inflammation

The purpose of the trial was to determine whether such patients could benefit from the inflammation fighting properties of statins. The actual statin used in the study was Rosuvastatin marketed by AstraZeneca as Crestor. I discussed the JUPITER trials in a previous post .

JUPITER epitomises what is wrong with the current medical paradigm

JUPITER epitomises everything that is wrong with the contemporary medical paradigm. To see why let’s take a look at the characteristics of the patients who participated in the JUPITER trials.

• They are a rather hefty lot. Three quarters of them are overweight (body mass index greater than 25) or downright obese (BMI greater than 30).
• About 15% of them are smokers! Using statins to combat heart disease in a smoker is like trying to fight a bush fire with a water pistol. You may as well not bother.
• The blood pressure of the participants tends to be on the high side and over 40% suffer from metabolic syndrome. Metabolic syndrome is a common consequence of an unhealthy lifestyle.

In short, the trial participants are an unhealthy lot. This is not surprising. Elevated CRP levels are most often associated with being overweight or obese, smoking and lack of exercise.

Let’s be clear on something. Not everyone who has elevated CRP levels leads an unhealthy lifestyle and not everyone who leads an unhealthy lifestyle has elevated CRP levels. However unhealthy lifestyles and elevated CRP levels are often associated. Judging by what we know of the trial participants it is fair to assume that many eat too much of the wrong kinds of food and do not get enough exercise.

Now we see why the very idea behind the JUPITER trials is flawed. We already know that certain lifestyle changes can both reduce CRP levels and reduce the risk of cardiovascular disease. Here is the good news:

• Lifestyle changes can reduce the risk of cardiovascular disease
• Lifestyle changes do not carry any of the risks associated with taking statins. (See here and here).
• As we have seen, taking Rosuvastatin is associated with an increased risk of type 2 diabetes. Lifestyle changes can actually reduce the risk of type 2 diabetes.
• Far from impairing brain function lifestyle changes can enhance brain function.

In subsequent posts I shall be presenting evidence for all the claims I am making about the benefits of suitable lifestyle changes.

It is likely that, as a therapy, lifestyle changes – a healthy diet and regular exercise - are in every way superior to medicating apparently healthy people with statins.

So what’s the downside to lifestyle changes? Why are we even bothering with statins?

We already know the answer. It is easier to pop a pill than to change your lifestyle. I write this without in any way meaning to disparage people who find it hard to change their eating and exercise habits. I can attest from personal experience how hard it is. But it is possible. In later posts I shall be describing evidence based strategies for effecting healthy lifestyle changes.

Will doctors change their clinical practice as a consequence of the JUPITER study?

Let us return to the JUPITER study. The editors of the New England Journal of Medicine which published the results of the JUPITER study ask readers, mainly doctors, whether it will change their practice. You can see how readers responded here. In response to the question “Do you believe, on the basis of the JUPITER trial results, that the therapeutic use of statins in apparently healthy adults should be changed?” 48% of readers answered “yes” and 52% “no.”

Note that if 48% of clinicians start prescribing more statins as a result of the JUPITER study AstraZeneca will recover the cost of financing the trials many times over. For them it will prove to have been a highly profitable investment.

What should the doctor tell the patient?

What should a doctor say to a somewhat portly 60 year old sedentary patient with elevated CRP levels?

It seems to me an honest doctor would have to say something along the following lines.

I’ve conducted a test that shows you have an inflammation in your body. That raises the risk of your getting cardiovascular disease. In other words, you are at increased risk of suffering either a heart attack or a stroke. One out of every 74 people with your condition suffers a heart attack or stroke every year.

I can prescribe this pill. You will have to take it for the rest of your life. If you take the pill it reduces the probability of your getting cardiovascular disease by 0.59% per year.

On the other hand you have a 1.17%chance per year of getting type 2 diabetes if you do not take the pill. If you choose to take the pill it increases the odds of your getting type 2 by 0.28% per year. Type 2 diabetes is a serious illness which itself carries an increased risk of cardiovascular disease as well as dementia.

One of the risks associated with taking the pill is damage to your muscles. Taking the pill may also cause your brain to function below par.

Alternatively you could try TLC.

TLC stands for THERAPEUTIC LIFESTYLE CHANGES. lt That means you change your eating drinking and smoking habits, get serious about losing weight and exercise for at least half and hour a day at least five days a week.

TLC is usually even better at averting the risk of cardiovascular disease than the pill. It also reduces the risk of getting type 2 diabetes and enhances brain function.

The downside of TLC is that most people can’t bring it off.

Which do you, Mr. Patient, want to try?

An alternative to the JUPITER study

Here is what I would have liked to see. Instead of two groups we needed four groups as follows:

• A placebo group
• A Rosuvastatin group
• A group that received lifestyle counselling and a placebo
• A group that received a combination of lifestyle counselling and Rosuvastatin.

The last group is necessary because there could be a synergistic interaction between statin therapy and TLC in which the benefits clearly outweigh the risks.

Such a study really would have thrown up which is the most effective therapy.

In a nutshell

The JUPITER study illustrates that medicating some apparently healthy people with statins brings about small benefits at the cost of not insignificant risks. The alternative of a “TLC” was not included in the study. TLC carries no risks and probably greater benefits.

JUPITER was hyped in a totally misleading fashion. The risks were understated. The benefits were overstated by using relative instead of absolute risk reduction. A relative risk reduction of almost 50% sounds much better than an absolute risk reduction of 0.59%.

In a nutshell that is what is wrong with the current medical paradigm.

What Paul Ridker has to say.

In fairness to the JUPITER study’s principle researcher, Dr. Paul Ridker, he emphasises that lifestyle changes should precede statin therapy. Here is what he said in a recent interview:

“…the first step is not a statin; the first step is diet, exercise, smoking cessation and getting into a good preventive program.“

Tags: astrazeneca, cardiovascular disease, crestor, diabetes, exercise, jupiter, lifestyle, ridker, rosuvastatin, statins, tlc

This entry was posted on Thursday, June 18th, 2009 at 4:12 pm and is filed under cadiovascular disease, diabetes, exercise, fitness, obesity. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed.