FDA Indicates Vytorin and Other Cholesterol Drugs Should Not Be Stopped

Despite concerns which emerged last year about whether Vytorin provides any benefits over cheaper, generic alternatives, the FDA indicated last week that their review of available data does not suggest that patients should stop taking the cholesterol lowering drug.

Vytorin, which is marketed jointly by Merck & Co and Schering-Plough Corp, is a combination therapy that contains Zetia (ezetimibe) and Zocor (simvastatin). The drug is used to treat high levels of cholesterol in the blood by reducing low density lipoprotein (LDL or ‘bad’) cholesterol.

In January 2008, preliminary results from a study known as ENHANCE were released, which indicated that Vytorin was no better than taking generic Zocor alone at reducing the build up of plaque in carotid (neck) arteries. This led several doctors to suggest that patients should be switched to different medications, since the primary purpose of lowering LDL cholesterol is to reduce the risk of cardiovascular disease.

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According to an update issued by the FDA on January 8, 2009, the agency recently completed their review of the data from ENHANCE and indicates that the findings do not change their position that lowering LDL cholesterol reduces the risk for cardiovascular disease. Therefore, the FDA says that patients should not stop taking Vytorin or other cholesterol lowering medications.

The ENHANCE study demonstrated that Vytorin lowers LDL cholesterol levels by 56% compared to 39% among those using simvastatin alone, which they indicate is statistically significant. However, the difference in carotid artery thickness was only minimally increased with Vytorin, which does not reach the level of statistical significance, meaning it could be due to chance.

The FDA indicates that an ongoing study known as IMPROVE-IT, which is scheduled to provide additional data about Vytorin’s effect on the risk of heart disease, is scheduled to conclude in three years.

“Pending the results from IMPROVE-IT, patients should not stop taking Vytorin or other cholesterol lowering medications and should talk to their doctor if they have any questions about these medications,” said the FDA in a statement posted on their website Thursday.

The FDA’s statement did not address a different safety concern which emerged later last year, involving a possible association between Vytorin and cancer.

Following the release of data in August 2008 from a separate study, known as SEAS, which identified a higher incidence of cancer among those taking Vytorin, the FDA released an Early Communcation indicating that they were awaiting the final report from the study before determining if there is a causal connection and whether any regulatory action is warranted.

At that time, the FDA indicated that the final SEAS safety review of the potential Vytorin cancer side effects would likely not be complete until May 2009.


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