New study confirms: LDL of 60 mg reverses plaque
TYP SITE - REPORT FROM MARCH OF 2006
The Track Your Plaque program has, from the start, advocated an LDL cholesterol of 60 mg or less to achieve plaque regression (heart scan score reduction).
A major trial has now confirmed this approach. What can we learn from this new experience?
.
Results of the ASTEROID study were just reported at the American College of Cardiology meetings in Atlanta. A study that showed a remarkable quantity of plaque reversal using a high-dose cholesterol drug, this study carries some exciting implications for Track Your Plaque program participants.
The ASTEROID Study—Out of this world results?
346 participants completed a two year course of treatment with the cholesterol drug, rosuvastatin (Crestor®), 40 mg (the maximum FDA-approved dose). The volume of coronary plaque was assessed using intracoronary ultrasound (IVUS), both at the start and after the 24-month treatment period. (IVUS is an invasive procedure performed during heart catheterization.)
Dr. Steven Nissen of the Cleveland Clinic, lead investigator of ASTEROID, reported that plaque was reduced by an average of 6.9% in the (10 mm) segments studied in each participant.
To achieve this endpoint, participants started with an average LDL cholesterol 130 mg and HDL of 43 mg. Two years of rosuvastatin yielded LDL cholesterols of 60.8 mg, HDL of 49 mg.
End of story? Is that all we have to do to reverse plaque?
The full story
We' re thrilled that Dr. Nissen and efforts like the ASTEROID trial are focusing on coronary plaque regression as a goal. This alone is a tremendous leap forward from previous "body count" studies. In these studies, success is measured by the number of deaths or heart attacks prevented. A powerful measure, yes, but at an enormous price in human life! Using a measure of coronary plaque is more precise and spares lives.
There is lingering speculation among some experts that plaque shrinkage will not yield reduction in dangerous events like heart attack and death. Nonsense! Every study over the past 20 years examining the benefits of plaque reversal have all also demonstrated dramatic reduction in "events". How many times does this need to be confirmed before the medical community stops making body counts to prove efficacy?
The fact that the trend to use a measure like plaque growth or reversal is therefore a major step in the right direction and consistent with Track Your Plaque principles.
That said, does a trial like ASTEROID prove that we all should be taking 40 mg of rosuvastatin? We don't think so.
We do believe that this trial persuasively confirms the theory that the lower LDL, the better for plaque reversal. The 60 mg LDL achieved with rosuvastatin 40 mg is the lowest achieved in any large trial to date. It also strongly suggests that outsized plaque reversing benefits can be achieved by raising HDL, in this case to an average of 49 mg, or an increase of about 15%. (Note that this is still below the Track Your Plaque HDL target of 60 mg.)
However, we take issue with several aspects of the ASTEROID experience:
* 22 participants in ASTEROID had heart attacks or required major heart procedures. That's still a substantial number. Could pushing participants to do more than reduce LDL to 60 and raise HDL to 49 have spared these people their "events"?
* 40 mg of rosuvastatin is difficult to tolerate in our experience. In ASTEROID, 4% of participants couldn't tolerate the drug due to muscle aches or liver toxicity. In published trials of other agents (e.g., Lipitor®) a similar percentage of people prove intolerant. However, this is dramatically different than our real world experience. Our experience has been that intolerance to the drug develops in over 30% of people at lower doses, over 50% at higher doses—of all of the statin drugs. (Many people can manage by replacing coenzyme Q10 depleted by statin drugs, but this was not provided in the study.) We are skeptical that most people can tolerate this dose of rosuvastatin over an extended period.
* What about lipoprotein(a), small LDL, low starting HDL, IDL, vitamin D deficiency, etc.? In our experience, reducing LDL cholesterol is just one part of the answer. Correcting all abnormal lipid and lipoprotein patterns can stack the odds even further in your favor. Similarly, what about pre-diabetic patterns that are rampant in Americans today? What role should diet play? There's lots of issues not addressed in this focused trial. In other words, it is unlikely that a shotgun approach using Crestor® all by itself will result in plaque reversal in the majority of people in a real world setting.
Despite our reservations, the ASTEROID trial still represents a major step forward in establishing the concept of coronary plaque regression as a desirable—–and achievable—goal.
But you can do even better. Follow the Track Your Plaque approach of identifying all plaque causes and then correcting all of them.
trackyourplaque.com |
