Zetia/Vytorin Study: A Perspective

You may have heard the considerable debate regarding the cholesterol-lowering medication, Zetia. Unlike statins which affect your cholesterol production, this drug blocks the absorption of both dietary and biliary (liver-produced) cholesterol into the blood stream. The drug is intended to provide individuals who cannot reduce LDL cholesterol using diet and exercise with an alternative to high dosages of statin medications. It also was developed for those who simply cannot tolerate statins.

In a recent controversial study reported in the New England Journal of Medicine, the effects of taking Zetia and the statin, Zocor, combined (together known as the drug Vytorin) was compared to the effects of taking Zocor only.

Here are results:

The group taking the two drugs experienced an LDL cholesterol decline that was 27% greater than the Zocor-only group.

Despite the increased lowering of LDL cholesterol in the group that received both medications, both groups saw arterial plaque build at rate that was similar (although those on the combination drug saw a somewhat larger, but not statistically significant, increase).

This finding is at odds with our traditional understanding of the favorable relationship between lower LDL cholesterol and atherosclerosis.

The trial, however, did not directly address whether lowering of LDL cholesterol with the combination drug reduces heart attacks, strokes and other cardiovascular “events.” The combination drug may or may not provide an additional benefit.

So how is the medical community responding?

An editorial in the New England Journal of Medicine observes that “it seems prudent to encourage patients whose LDL cholesterol levels remain elevated despite treatment with an optimal dose of a statin to redouble their efforts at dietary control and regular exercise,” leaving Zetia for special situations. Yet, well trained, qualified doctors continue to prescribe the combination drug more broadly, believing that a single study does not unseat established wisdom.

The human body is profoundly complex, and we simply do not know with certainty how any particular approach will affect our long term health and longevity. We can only play the odds as we know them today. This requires that each of us take an educated approach to our health. Kardea aims to enable the members of its community to make more informed decisions about cholesterol management and natural nutrition.

"Cholesterol Drug Bombs"-New York Times Editorial Misses Opportunity

Yesterday, the New York Times editorial board wrote "there have long been suspicions, but it was still very disturbing to learn this week that a heavily promoted cholesterol-lowering drug had flunked a clinical trial of its effectiveness in reducing fatty deposits in arteries....The drug, Zetia, and a combination pill that contains it, Vytorin...generated more than $5 billion in sales last year."

You probably know the ads for Vytorin. They have run on T.V., in magazines and on-line. They certainly are clever, creative and very expensive. According to Nielsen Monitor-Plus, in 2006 the companies spent $136.3 million to advertise Vytorin and $115 million from January to October of 2007.

Vytorin combines Zocor, a statin produced by Merck (and also marketed by generic drug manufactures and sold at lower prices) with the Schering-Plough's Zetia. Statins work by reducing the production of cholesterol in the liver. Zetia works to reduce the absorption of dietary and liver-produced cholesterol from the intestines into the blood stream.

The study compared the effects of treating patients with Vytorin, the combination drug, with a statin alone. The patients all had abnormally high LDL cholesterol. In the study, LDL cholesterol was reduced more significantly by Vytorin than with the statin alone. These results are consistent with the results of a number of other studies.


It also was hypothesized that the added cholesterol-lowering effect of Vytorin would lead to a more significant reduction of arterial plaque growth. This relationship did not hold. The lower cholesterol achieved by the Vytorin did not yield a reduction in plaque build-up as compared to the statin only. In fact, the Vytorin group was found to have a more rapid development of plaque than the statin-only group.

The Times reports that these companies had been “cynically sitting on the results for more than a year” while spending hundreds of millions of dollars to convince consumers that the Vytorin is a preferred cholesterol drug. This certainly is a very legitimate criticism.

The Times continued that "the findings also raise doubts about the current belief that lowering cholesterol is the key to cardiovascular health. The study showed that Vytorin reduced bad cholesterol significantly more than Zocor alone. The problem was that it failed to reduce the formation of plaque."


And here is perhaps were the Times should have been somewhat more careful. This study now represents a single set of data among a sea of data that concludes lower LDL cholesterol lowers the risks of heart attacks and strokes. Numerous studies also indicate that LDL cholesterol above 100mg/dl will lead to the development of arterial plaque.

Instead of casting doubt on the general wisdom of cholesterol management, the Times would have served the public well by offseting the barrage of pharmaceutical advertising and reinforce the well-documented science regarding natural alternatives to cholesterol management. An extensive NIH report (http://www.nhlbi.nih.gov/health/public/heart/chol/chol_tlc.htm), for instance, concludes that the "amount of LDL reduction from Therapeutic Lifestyle Changes compares well with many of the cholesterol-lowering drugs." Among the recommendations are the consumption of certain positive nutrients such as plant sterols, soluble fibers, monounsaturated fats in place of saturated and trans fats, and Omega-3s. Needless to say, weight management and exercise is part of the NIH recommendations.

For more information on natural cholesterol management nutritients: http://www.kardeanutrition.com/cholesterol/program.aspx