Vytorin and Zetia May Not Work: Cardiologists

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Chicago, ILThe message could not have been clearer. At a major cardiology conference Sunday in Chicago, a gathering of 5,000 of the country's leading cardiologists were told unequivocally that cholesterol drugs Vytorin and Zetia should only be used as a therapy of last resort, given the now-widely-held view that the two drugs may not work.

The presenters urged their colleagues to switch their patients back to statins.

That position, also reflected in an editorial in the current issue of the New England Journal of Medicine published the same day, is the strongest condemnation yet of Merck and Co, and Schering-Plough's once-ballyhooed cholesterol drugs.

Cardiology Conference""The strongest recommendation we can make on this panel, is to go back to statins," said Dr. Harlan M. Krumholz, a cardiologist from Yale and one of four noted cardiologists on a panel presenting to the conference sponsored by the American College of Cardiology.

The focal point of the conference was the ENHANCE trial, the preliminary results of which were released in January. Full results were available this month and discussed in detail at the conference.

While the manufacturers of Vytorin and Zetia stand by their product, the nation's cardiologists appear to be in agreement that a huge question mark surrounding Zetia and Vytorin still remain: does it work?

Worse still, do Vytorin and Zetia actually contribute to the problem? There is some speculation that the two drugs might even contribute to the build-up of plaque on arterial walls.

To answer those questions conclusively, a long and painstaking process known as a clinical outcomes trial, is required. The latter involves 10,000 participants or more and can take years. Merck and Schering-Plough initiated such a trial two years ago and began enrolling participants into the multi-year outcomes trial. Results were expected in 2011, but the companies said Friday that results are now not expected until 2012 or later.

Doctors, it seems, are not prepared to wait and maintain the status quo—especially since statins, a different class of cholesterol drugs, are older and are backed up by favorable outcomes trials. Statins, cardiologists were told, have been proven to lower the risk of heart attacks and strokes.

"We've got a drug that has no clinical outcome trials," said Dr. Steven Nissen, noted cardiologist and the Chair of cardiology at the Cleveland Clinic. "I advise my colleagues essentially to use this drug only as a last resort."

Vytorin is a combination of two existing cholesterol drugs made by two different manufactures. Zocor, a statin drug, is made by pharma giant Merck. Zetia, a relative newcomer to the fray, is from Schering-Plough and was approved by the US Food and Drug Administration (FDA) in 2002. Zetia was designed to block the absorption of cholesterol in the intestine. Zocor, on the other hand, is a statin and blocks the liver from producing cholesterol in the first place. Statins have been around longer and have favorable outcomes trials to back them up, which is why cardiologists are being urged to go back to them until science provides for conclusive evidence showing that Vytorin—Zetia combined with Zocor—and Zetia on its own, actually work.

Sunday's conference will more than likely represent a huge blow for Merck and Schering-Plough. Even though it is estimated that about three million prescriptions are written each month in the United Sates for Vytorin, sales have dropped about 15 per cent since news of the ENHANCE trial was released at the first of the year. With the full trial results now available, and a strong recommendation for cardiologists to consider Vytorin and Zetia only as an avenue of last resort, the implications for the manufacturers are massive.

For example, Vytorin represents about 70 per cent of Schering-Plough's profit, according to reports.Sales of Vytorin and Zetia combined were in the neighborhood of $5 billion worldwide last year, and are among the top-selling drugs on the planet.

A spokesperson for the Schering-Plough research institute said Sunday that Vytorin and Zetia have both proven to lower cholesterol. And that appears to be true. It has been previously reported that levels of the so-called bad LDL cholesterol, which has been linked to the build-up of plaque and the onset of heart attack and stroke, were lower with Vytorin, than with statins alone.

However, it was reported back in January that while LDL cholesterol levels in Vytorin patients were lower, it did not appear to have a favorable impact on plaque build-up. Statins, on the other hand, have been found to reduce LDL cholesterol levels together with a favorable impact on plaque build-up, and was therefore shown to conclusively reduce the risk of heart attack and stroke.

In the end, the cardiologists are putting their faith in hard science, over marketing. As long as questions remain over Vytorin and Zetia, the nation's 10,000 cardiologists are being urged in the strongest of terms to stick to statins, until results of clinical outcomes trials become available.

They have also been heavily marketed, and patients of Vytorin and Zetia—which can be more expensive than older statins—can be forgiven for their anger given the belief that Vytorin was effective in lowering the risk for heart attack and stroke, when results from the ENHANCE study allegedly suggested otherwise. It has been reported that Merck and Schering-Plough had the results in-hand two years ago, but allegedly delayed the release of the full study until this March. Preliminary results were released in January after Congress pressed the manufacturers for details.

Given the massive marketing campaign that helped generate billions of dollars in sales, while data in-hand suggested the product may not work, the companies have since been accused of misleading advertising.

Sunday's revelation will only add to the discontent of Vytorin patients who feel they have spent hard-earned health dollars needlessly, on a product that, in the words of the cardiologists gathered in Chicago Sunday, 'may not work.'

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