After Further Review, Vytorin Gets FDA OK

Regulatory Agency Says Patients Should Not Stop Taking Vytorin Or Other Cholesterol Drugs

(AP)  The Food and Drug Administration said Thursday patients should not stop taking Vytorin or other cholesterol-lowering drugs, based on its just-completed review of a controversial study that hammered Vytorin sales.

A statement issued by the regulatory agency said it is sticking to its original position that that medicines that reduce bad cholesterol benefit patients at risk of heart attack, stroke, or sudden death.

For the past year, many experts have instead been saying — based on results of the study of cholesterol drugs sold by Merck & Co. and Schering-Plough Corp. — that reducing cholesterol levels isn't enough to reduce those risks if there's no evidence the medicines control plaque buildup in arteries.

Vytorin, a pricey combination pill, is sold by a joint venture of Merck, based in Whitehouse Station, N.J., and Schering-Plough, based in Kenilworth, N.J. It contains drugs that lower cholesterol in two different ways: Schering-Plough's Zetia, which reduces the amount of cholesterol absorbed from food, and Merck's former blockbuster Zocor, which lowers the amount of cholesterol produced by the body based on one's genes. Zocor got generic competition in June 2006, and those versions cost about one-third as much as Vytorin.

"The price differential between the two products is so big that this may not make much of a difference" in sales of Vytorin and Zetia, said analyst Steve Brozak of WBB Securities.

In a stronger economy, the FDA statement likely would bring a bigger boost to sales of the drugs, he said.

Last January, initial results of a study called ENHANCE showed Vytorin was no better than Zocor at reducing plaque buildup in neck arteries — indicating Zetia gave no added benefit over Zocor. That led several prominent doctors to urge patients to abandon Vytorin in favor of older cholesterol drugs with a longer track record. Sales of both Vytorin and Zetia began falling almost immediately as a result.

On Thursday, FDA said it had completed its review of the final report on the study. The agency said results showed that after two years of treatment, even though there was no difference in the thickness of plaque in the carotid artery in patient groups that got either Vytorin or Zocor, there was a significant difference in cholesterol levels.

Those in the Vytorin groups saw their level of bad, or LDL cholesterol, fall by 56 percent, versus a 39 percent drop in the Zocor group, FDA wrote in a statement.

That big of a difference normally would be "a big deal," Brozak said.

In its statement, the FDA wrote that, "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."

The drugmakers' 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.

[drivelphobe]

Funny, years ago, a cholesterol level of 220 or less was considered okay. Today, they want you at 160 or less. Can''t sell any drugs without a good reason.

The other day on TV, a physician indicated that a normal BP reading was 115 over 75. The standard has been 120 over 80 for my entire lifetime.

The medical community is dedicated to discovering new ways to treat the healthy by redefining normal and fixating on more complex and expensive annual checkups and preventative medical testing.

If you aren''t in need of medical care for an illness or injury, stay away from the doctors. They will find a reason to test you into poverty, never diagnosing the condition and referring you to their friends and colleagues until you are deceased. They never get to the bottom of anything, and you get to pay for all the BS over and over.

I am disgusted with the repetitive testing and the constant "I don''t know what the problem is" routine. It''s like the auto mechanic who gets to keep charging as he tries to figure out what is wrong. After replacing the starter, the alternator, the ignition wires, and fuel pump, he tells you the battery,which you just purchased, has a bad cell and is covered under a warranty. Meanwhile, all the original parts have been replaced with rebuilds and items from China, and you''re out hundreds of dollars for nothing.

[toolmangler-2009]

Vytorin has my levels reduced by 47%, one heart attack is enough for me. Dying is the pitts

[notfooled]

The FDA is controlled by the big pharmacutical houses.

The FDA is basically a rubber stamp.

Can''t trust folks whose main concern is the bottom line of some drug pushing company''s profit sheet.

[renonv5]

They did 500 studies and only one shed a positive light, so thats the one they published. It is ALL ABOUT MONEY and to he!! with people''s health.

[brannigon]

You can be sure there''s a money deal going on here! This country is being run by crooks! Wonder what kind of "settlement" went on here?