Gettysburg Medical Center
The Clinical View
by P.E. Hoffsten, MD
30 January 2008

THE VYTORIN MESS:  MORE MEDICAL TERRORISM

            This past several weeks has witnessed a new depth of unreliable, misleading reporting by television news services.  Specifically, they reported that Vytorin which is an anti-cholesterol  medication was ineffective and dangerous.  Nothing could be further from the truth.

            There is a principal in medicine that a small amount of two different medications work better than a whole lot of one of them.  This is true for lowering blood cholesterol.  Many people have heard of so called “statin” drugs that have been spectacular in their effectiveness in preventing heart attack, stroke and peripheral vascular disease.  But as good as these drugs are, they still do not lower cholesterol into acceptably low ranges for some people.  Individuals who have had a previous heart attack or who are diabetic should have a LDL (bad cholesterol) of 70 mg% or less.  This is very difficult to achieve using a statin alone. 

            Several years ago, a product called ezetimibe (Zetia) was discovered which blocks the reabsorption of cholesterol from the bowel.  Used alone, this product has relatively little effect in lowering the blood cholesterol.  As soon as the body finds out that the reabsorption of cholesterol is being blocked, the liver simply makes more cholesterol and the blood levels stay about the same.  However, if ezetimibe is used together with a statin drug, the two drugs are very effective in lowering the blood cholesterol to the lowest levels of any product that we found thus far.

            It should be known at this time that virtually every single study which has looked at populations with high blood cholesterol, lowering that cholesterol value has been beneficial.  There have been studies done where atorvastatin alone was administered to heart disease patients who had elected not to pursue a recommended surgical intervention.  When these studies were done, those individuals taking 80 mg a day of atorvastatin (Lipitor) fared as well as the individuals who had accepted the suggestion that they proceed with surgery.  Not everyone can tolerate 80 mg a day of Lipitor but those that can seem to benefit very highly even without surgical intervention for their severe coronary artery disease.  This result gives support and credence to the idea that the lower bad cholesterol, the better. 

            Thus, Vytorin was introduced to the market as a mixture of a statin drug (simvastatin/Zocor) with ezetamibe (Zetia) together and it is clearly the most effective cholesterol lowering product on the market.  When Vytorin was introduced to the market, it made no claims of preventing heart attacks or strokes because the studies had not been done yet.  It did, however, claim that it lowered the blood cholesterol very substantially and that was true.  In order to evaluate the effectiveness of Vytorin in preventing vascular disease, the Merck Pharmaceutical Company undertook a study called ENHANCE.  This was a study done with a very select population of individuals who had one gene of a condition called familial hypercholesterolemia.  This is a very bad disease and people with this genetic trait have an accelerated rate of heart attack and stroke.  The Merck Pharmaceutical Company decided to treat this very badly affected group with their drug Vytorin to see if it would do better than using simvastatin alone which is half of the Vytorin product.  Their method of evaluation was to use the thickness of the lining of the carotid arteries in the neck.  They were not trying to see if they could prevent heart attacks or strokes; they wanted to see if they could prevent the progression of the atherosclerotic changes that occur in these familial hypercholesterolemic individual’s carotid arteries.  When the study was done, it was found that simvastatin alone worked every bit as well as using Vytorin which is the mixture of simvastatin and ezetimibe.

            Now please note there was no part of this study that was designed to see if the drugs prevented heart attacks or strokes.  In addition, this was not a study of the general population and thus there was no impact or expected impact on the question of whether Vytorin was better for the general public than was simvastatin alone. 

            But that is not what the TV and news media picked up.  They ballyhooed that Vytorin was a failure in preventing heart attacks and strokes which was not even measured in this study and then some clunk-head decided to sue the Merck Drug Company with a class action suit for misrepresentation.  The Merck Drug Company did not misrepresent their drug.  They did not claim that it would prevent heart attacks or strokes but the scum sucking, bottom feeding lawyers who make their money off of this type of misrepresentation swarmed to the possibilities here.  It is no wonder that our drug costs are so high by the time we have to factor in the expense of the drug company defending themselves against this type of lying and cheating. 

            In summary, Vytorin is not a dangerous drug.  It was not effective in stopping carotid artery intimal thickening in the study that was done on a select population heterozygous familial hypercholesterolemics.  It has no claim to stopping heart attacks or strokes.  That data will be forth coming in the next few years but it is not available at this time.  Until then, doctors who would prescribe Vytorin, do so with the information that in every study done the lower the cholesterol, the less likely the person is to have a heart attack or a stroke and therefore, we use the best medication to get the cholesterol as low as we can especially in those individuals who have had aheart attack or those individuals who are diabetic and very likely to have a heart attack. 

            As for the TV and news commentators, one wonders if there is really such a thing as an Iraq war or terrorists or primary elections.  If they screw up information so badly as they did on this particular report, one wonders if anything they ever say is true.

This and other columns available at www.macpierre.com.