FDA supports use of cholesterol drug Vytorin

Washington, January 9: After almost a year of review, the Food and Drug Administration reported on Thursday that they are supporting the continued use of the cholesterol-reducing drug Vytorin.

The FDA stated that, "Based on current available data, patients should not stop taking Vytorin or other cholesterol lowering medications and should talk to their doctor if they have any questions about Vytorin, Zetia, or the Enhance trial."

Vytorin is an expensive combination drug from Merck and Schering-Plough. It is composed of Merck’s popular drug Zocor which reduces the cholesterol in one’s body based on their genes and Schering-Plough’s Zetia, which reduces cholesterol absorption from food.

Early last year, a controversy over Vytorin sparked after a study called Enhance showed that it had almost the same effect as the drug Zocor. Because of this the sales of both Vytorin and Zetia fell.

On Thursday, the FDA gave their review of the final study report on the Enhance trial. They reported that though there was no difference in carotid artery wall thickness between patients who were taking Vytorin or Zocor, a significant difference in cholesterol levels was observed.

The FDA report stated, "Following two years of treatment, carotid artery thickness increased by 0.011 mm (millimeters) in the Vytorin group and by 0.006 mm in the simvastatin group. The difference in the changes in carotid artery thickness between the two groups was not statistically significant. However . . . the difference in the reductions in LDL cholesterol between the two groups was statistically significant.”

The low-density lipoprotein (LDL) decreased by 56 percent and 39 percent for the patient group taking Vytorin and Zocor, respectively.

The amount of LDL cholesterol in the body is related to a person’s risk of developing cardiovascular diseases such as heart attack and stroke. With the FDA report that Vytorin greatly decrease the LDL cholesterol in the body, the drug may take this chance to improve its sales.

Both Merck and Schering-Plough took the FDA announcement positively, saying, "We are pleased that the agency has completed its review of the ENHANCE study.”

After the FDA report was released, stocks of Merck closed at $29.39 while stocks of Schering-Plough increased by 2.7 percent, closing at $18.19.