Cholesterol Drug Vytorin gets FDA backing

Trenton, New Jersey, January 9: U.S. health officials are coming in support of cholesterol drug Vytorin, thus putting all past controversies to a rest. It has been a year, since this controversial cholesterol-lowering drug had been the subject of debates that had lowered the sales figures of Vytorin.

After the just completed review of a controversial study, the FDA has also made it clear that medicines used for controlling bad cholesterol are also beneficial for patients at risk of stroke, heart attack or sudden death.

The U.S. Food and Drug Administration(FDA) has asked patients not to cease using Vytorin, after year long reviews showed evidence that it lowered bad cholesterol more effectively than Zocor.

The FDA, in its statement said, “Based on currently available data, patients should not stop taking Vytorin or other cholesterol-lowering drugs and should talk to their doctor or other health care professional if they have any questions.”

Former American Heart Association President Dr. Valentin Fuster, now director of the Mount Sinai Heart Center in New York, backed the FDA’s statement, saying, “What the FDA is saying is exactly the way I'm practicing.”

The current heart association president Dr. Timothy Gardner also agreed with the FDA. “Patients who are taking Vytorin without difficulty should continue until there's any further relevant information,” he maintained.

The agency officials reported that though, there was no significant difference in carotid arterydefine thickness between patients taking Vytorin and those using Zocor, there was a considerable difference in the levels of LDL, bad cholesterol. The levels of bad cholesterol decreased by 39 percent only in Zocor group as compared to 56 percent in those belonging to the Vytorin group.

Vytorin has been the subject of numerous debates and discussions for almost a year when results of ENHANCE trial maintained that the drug was of little benefit. Last January, Vytorin’s makers had released a study, which stated that the drug, a combination of Zocor (simvastatin) and Zetia (ezetimibe), gave no added benefit over Zocor at reducing plaque buildup in neck arteries. All this had led to several prominent physicians urging patients to abandon Vytorin and start using older cholesterol drugs with a proven track record, thus badly affecting sales of both Vytorin and Zetia.

The Mount Sinai doctor Fuster said he never stopped prescribing Vytorin for his patients for several reasons including some cited by FDA. Referring to heart attack and stroke, Fuster stated, “There is no evidence from any trial that (significantly) lowering cholesterol does not decrease coronary events.”

Sold by a joint venture of Merck (based in Whitehouse Station, N.J.) and Schering-Plough (Kenilworth, N.J.), Vytorin is a pricey combination pill. The drug-makers' joint venture issued a brief response repeating that statement. “We are pleased that the agency has completed its review of the ENHANCE study,” the companies said.