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Long-awaited results from a study of Vytorin have been met with disappointment and accusations by the medical community.

Vitorin, a best-selling cholesterol drug which combines Zetia with the statin drug simvastatin, was found to have made no difference in reducing plaque buildup in the carotid arteries than simvastatin alone. Results showed that patients taking Vytorin actually had slightly more plaque buildup that those taking simvastatin alone.

Cardiologist Steven E. Nissen, MD, called the results "a stunning reversal for Zetia and Vytorin." Nissen is chairman of the department of cardiovascular medicine at the Cleveland Clinic, and is a past president of the American College of Cardiology. "Zetia works only by blocking the absorption of cholesterol, but it has not been shown to produce any health benefits," he says. "I have been skeptical of these drugs from the beginning because I wasn't sure that Zetia's mechanism of cholesterol lowering would produce the same benefits that we see with statins."

Accusations of misconduct on the part of the pharmaceuticals have also surfaced. Congress has announced an investigation into the companies' actions regarding the study. While the study ended nearly two years ago the results were released this part Monday. In addition to the long delay in releasing the results, the companies have been accused of trying to change the endpoints of the study in an attempt to have more favorable results.

Two congressmen leading the investigation issued a news release and stated:

"Today's announcement that the ENHANCE study failed to find any positive benefit from the addition of Zetia to a common, inexpensive, generic therapy raised concerns that attempts were made to mask the minimal value of this new drug," Committee on Energy and Commerce chairman John Dingell, D-Mich., charged.

Rep. Bart Stupak, D-Mich., who chairs the oversight subcommittee, said the investigation will continue.

"In light of today's results, which were released nearly two years after the ENHANCE trial ended, it is easy to conclude that Merck and Schering-Plough intentionally sought to delay the release of this data," Stupak said. "It's currently unclear whether these companies knew that adding a new expensive drug accomplished nothing more than an established cheaper generic. But it is clear that our investigation is far from over."

Schering-Plough defends the delay by stating that the delay was a result of the complexity in interpreting the data. The company also stated that the study was designed to assess the plaque buildup in high-risk patients and not to look at outcomes such as stroke, heart attack and death.

Results from three larger trials of 20,000 patients are expected to answer if Zetia and Vytorin prevent more adverse events than statins alone.

[Source: WebMd]