JUPITER to Earth: It's the Calcium Score Stupid!
The study known as the "Justification for the Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin" (JUPITER), was a classical large, long-term, double-blind, placebo-controlled, randomized clinical trial designed to determine whether it made sense to start statin treatment (in this case 20 mg of rosuvastatin or Crestor) in healthy individuals with low LDL-cholesterol levels but with elevated C-reactive-protein (CRP) levels.
The study was ended early because the trial monitoring board observed "unequivocal evidence of a reduction in cardiovascular morbidity and mortality." The bottom line is that even those patients who already had low cholesterol but had high CRP benefited through reduced cardiovascular events.
This was great news for Astra-Zeneca, the maker of Crestor. With over 15,000 multinational participants and years of tracking the study provided hard scientific evidence that widened their market substantially. Crestor was now not only the "super statin" of choice for persons with stubbornly high cholesterol and those looking to simply take a smaller statin dose, it now had indications for use by people with normal or even low LDL cholesterol as long as their CRP was high.
Astra-Zeneca took a great deal of criticism in the past for their aggressive marketing approach. Even the prestigious medical journal "Lancet" took them to task for an "unprincipled campaign" citing a lack of reliable efficacy and safety data. Now the drug maker was armed with an large and impressive body of clinical data with hard end points - cardiovascular events - not just lipid improvements.
It is clear to this observer that Astra-Zeneca was indeed running the JUPITER trial in an effort to find additional markets for their product, but, this where the story becomes interesting. The original focus of the study was to see if Crestor helped people with high CRP. However, the study was so large that the researchers were able to do multiple sub-studies of different participant groupings in a broad effort to determine who else might be helped by treating them with Crestor thereby further expanding their market. Recently, a group of researchers using data from the MESA study analyzed their population using JUPITER criteria. MESA population data varied from the JUPITER population in that they had many other health factors recorded included calcium scores. In the process, they found some very interesting data that may well serve not only known heart disease sufferers but asymptomatic persons as well.
New findings from the JUPITER/MESA post hoc analysis were recently released at the 2010 AHA Conferences in Chicago. What did they find? Here it is. The single greatest risk factor for a cardiac event is having a non-zero calcium score. This factor alone imparted a 25-fold increase in risk for cardiac events over persons with a zero calcium score.
The take-away concept here is not that you should take a statin if you have a positive heart scan score. What is important is that in the process of trying to find ways to expand its market Astra-Zeneca inadvertently helped corroborate that coronary calcium is the best predictor of future coronary events. They added more evidence that coronary calcium scoring is the best way to identify heart disease well before other symptoms appear.
If you have a positive calcium score you probably have atherosclerosis. Does it mean you WILL have a heart attack and you NEED as statin? No! What it does mean is that if you have a positive calcium score you do not need to wait until you have a heart attack, angina, or chest pain to start treating it. That early warning could be a life saver.
Looking out for your heart health,