Heavily Marketed Drug Vytorin Awaits Approval from FDA

January 28, 2008

(Long Island, N.Y.) Merck & Co./Schering-Plough Pharmaceuticals, the sole distributor of the drug Vytorin which claims to lower cholesterol levels at a more effective rate, will have to wait for the final trial results before the FDA will make a decision for the release of the drug to the public.

Vytorin is a combination of ezetimibe, best known as Zetia in the United States and the statin drug simvastatin best known as Zocor in the U.S. and is said to be dramatically more effective than taking regular drugs to reduce the build-up of plaque in the arteries. After months of heavy marketing for Vytorin, experts in the medical field criticized the usefulness of it since early indications have shown that taking the much expensive drug reacts in the same way as taking Zocor or scientifically known as simvastatin alone.

Dr. John Jenkins, director of the FDA’s Office of New Drugs, Center for Drug Evaluation and Research said “We have not yet received a final study report and can’t explain why Vytorin didn’t lead to lesser amounts of plaque compared to patients treated with simvastatin alone, once we receive the final study report, we estimate it will take as long as six months for us to fully evaluate the results of the Enhance study,” he said. “And we will be considering whether any further action is warranted in regard to Zetia or Vytorin, and also whether this study has any impact on our approach to the approval of lipid-lowering drugs.”

An enhanced trial was conducted which resulted in two critical findings. First in a more positive manner, it conclusively reported that by taking Vytorin it reduces cholesterol levels effectively. Secondly and the most damaging to the claims of Merck & Co./Schering-Plough Pharmaceuticals, the study showed that the build-up of plaque, which causes the arteries to clog up, was doubled in patients taking Vytorin rather than Zocor alone.

Dr. Harlan M. Krumholz professor of the Yale University School of Medicine said that “We have enough information from Enhance to say it is not providing much evidence that this drug is delaying the progression of atherosclerosis, it raises uncertainty whether this drug produces benefits for actual patients.” “This [Vytorin] is really a second-line drug,” Krumholz said. “We really should be guided by evidence, not marketing, and the evidence is really strong for statins. If lifestyles aren’t sufficient to lower cholesterol, the next place they should go is statins. Only after those have failed should you go to the next step,” he added, referring to Vytorin.

Posted by News LI Editor · Edited by Brianna - Filed Under Health