Doctors Rethink New Cholesterol Treatments

Study Showing Vytorin Does Not Improve Heart Disease Prompts Return To Older Statin Drugs

(CBS/AP)  Leading doctors urged a return to older, tried-and-true treatments for high cholesterol after hearing full results Sunday of a failed trial of Vytorin.

Millions of Americans already take the drug or one of its components, Zetia. But doctors were stunned to learn that Vytorin failed to improve heart disease even though it worked as intended to reduce three key risk factors.

"People need to turn back to statins," said Yale University cardiologist Dr. Harlan Krumholz, referring to Lipitor, Crestor and other widely used brands. "We know that statins are good drugs. We know that they reduce risks."

The study was closely watched because Zetia and Vytorin have racked up $5 billion in sales despite limited proof of benefit. Two Congressional panels launched probes into why it took drugmakers nearly two years after the study's completion to release results.

CBS New correspondent Randall Pinkston reports that two states' attorneys general, including New York's Andrew Cuomo, are also probing whether corporate insiders at the pharmaceutical companies that make these drugs dumped stock before the critical studies were released.

"The full results of the study released today, showing that Vytorin had no effect on heart disease, put the lie to Merck and Schering-Plough's $200 million advertising campaign urging Americans to take this drug," Cuomo told CBS News.

Results were presented at an American College of Cardiology conference in Chicago Sunday and published on the Internet by the New England Journal of Medicine.

Doctors have long focused on lowering LDL or bad cholesterol as a way to prevent heart disease. Statins like Merck & Co.'s Zocor, which recently came out in generic form, do this, as do niacin, fibrates and other medicines.

Vytorin, which came out in 2004, combines Zocor with Schering-Plough Corp.'s Zetia, which went on sale in 2002 and attacks cholesterol in a different way.

The study tested whether Vytorin was better than Zocor alone at limiting plaque buildup in the arteries of 720 people with super high cholesterol because of a gene disorder.

The results show the drug had "no result - zilch. In no subgroup, in no segment, was there any added benefit" for reducing plaque, said Dr. John Kastelein, the Dutch scientist who led the study.

That happened even though Vytorin dramatically lowered LDL, fats in the blood called triglycerides and a measure of artery inflammation - CRP.

Some doctors noted that hormone pills for menopausal women and torcetrapib, a promising cholesterol drug Pfizer Inc. recently abandoned, also lowered cholesterol but were found in big studies to raise heart risks, not lower them.

Another ominous sign was the decision Friday by other researchers to expand enrollment in a more pivotal study of Vytorin to 18,000 people because early results suggest it will be harder than anticipated to see if it is any better than Zocor alone.

"It will be 2012 - ten years after the drug was introduced - before we know the answer," said Dr. Steven Nissen, a Cleveland Clinic cardiologist who has no role in the studies and has criticized the drugmakers over the one reported Sunday.

Dr. Robert Spiegel, chief medical officer for Schering-Plough, said the study was done "with the highest integrity" and that doctors can believe the results "because of the time we took to make sure the data are right."

"We were disappointed that it was not a very balanced panel discussion" by the heart doctors who urged their peers to focus on more established treatments.

However, Kastelein said the data were far more consistent than anticipated and ample to show that the drug simply did not work.

"A lot of us thought that there would be some glimmer of benefit," said Dr. Roger Blumenthal, a Johns Hopkins University cardiologist and spokesman for the American Heart Association.

Many doctors have prescribed Vytorin without trying older, proven medications first, as guidelines advise. The key message from the study is "don't do that," Blumenthal said.

No one should ever stop any heart drug without talking with their doctors, heart specialists stressed.

However, doctors "should be thinking twice," said Duke University cardiologist Dr. Robert Califf. He takes the drug himself because he cannot tolerate the high dose of statins he otherwise would need.

Dr. James Stein, director of preventive cardiology at the University of Wisconsin-Madison, said many doctors prescribe Zetia and Vytorin because they seem to be safe ways to get cholesterol down quickly, without annoying side effects like flushing that some other medicines carry.

Stein, who has consulted for Schering-Plough, said that after six years on the market, it would have been good to see better results on a drug so many doctors believed would help, "but the reason we do research is so we don't have to rely on our 'beliefs' - we can rely on data."

The New England Journal also published a report showing that Vytorin and Zetia's use soared in the United States amid a $200 million advertising blitz. In Canada, where marketing drugs directly to consumers is not allowed, sales were four times lower.

Merck is based in Whitehouse Station, N.J.; Schering-Plough, in Kenilworth, N.J.

[jonesforch]

You can not even talk topics with out posting others postings..

[jonesforch]

Jonesforch

I did NOT post that.

[jonesforch]

seandgreen

Yeah, well...I could just let you sit around here all alone without some antagonistic rhetoric of my own, now could I? HA!

Hmmmm....

How you think I have an alliance with FDA/Pharma is beyond me...but hey, believe what you want. Just how in the hell do you think they "look after me?" I get NOTHING from them. Oh..I take that back...I got 3 gel pens from one of the reps the other day. Oh boy.

I''m impressed..NOT

[apprxam]

In Canada, Big Pharma isn''t allowed to advert to the populace and doctor there are five times less likely to prescribe Vytorin than American physicians. We know the effect of marketing on the human subject, but what troubles me is that doctors, especially those in cardiology, allow themselves to be tricked, conjoled or whatever else, into filling them time and again. The AMA, JAMA and the cadiology associations does nothing to guide their members in providing their patients with the best care possible.

So much for big, evil social medicine in Canada. I remeber when congress was trying to prevent border state resident from going up north to fill their prescriptions because they wanted to protect us. That''s Congress, always looking out for the little gal/guy. But nothing on this issue from them.

[drinuk]

Your current thoughts on MMR and Hannah Poling would be interesting too

[drinuk]

See your back seandgreen ! waving that Big Pharma Flag again, they must look after you real well.

Give us the latest on Heparin ?

[erasmus6]

"Ok, I take Vytorin because I have Cirrhosis but Lipitor and others make it worse, so now what?" Posted by ToolMangler

Well it showed that it did dramatically lower LDL and a "measure of artery inflammation", right? It just doesn''t remove the plaque that is already there. That is better than nothing. If you can''t take the other drugs then what are you going to do? You will have to keep taking it, unless of course they pull it from the market.

My mom has a problem with medications for pain relief for arthritis. She is allergic to everything except Celebrex. Celebrex has been found to cause problems with the heart depending on how much you are taking and for how long. (she has problems already with her heart) They haven''t pulled it from the market and she was told to keep taking it. What can she do? If she doesn''t want to suffer, she has no choice.

On T.V. they advertise all these different drugs and then they tell you all the side affects and what it can do. It scares the hell out of me, so I prefer to take my chances. I figure either the problem will kill you or the drugs will and I prefer not to put poison into my body.:)

[toolmangler-2009]

Ok, I take Vytorin because I have Cirrhosis but Lipitor and others make it worse, so now what?

seandgreen, you have vindicated everything I told you. You can stand with Big Pharma and The FDA and keep believing that they only thing that cures is drugs, drugs, drugs, and if that fails, then surgery, surgery, surgery. I will waste no time with your blocked mind.

[seekingsense]

seandgreen, I understand your position. Educating your patients on their current choices is hard enough without having to debunk all the information clutter available to us all these days. It must be very frustrating after all your careful study to have to defend against some idea that has no merit.

The whole problem is similar to many other situations, where people look for simple immediate answers to complex problems that have cause(s) and effect(s) separated by both time and possibly many intermediate steps that are not obvious or intuitive. It makes it very difficult to adequately explain to someone how or why something happens, especially if their experience base is limited.

You know all those contestants singing on TV that are so demolished by the verdict that they can''t sing? They can''t properly judge their own singing because in their inexperience, they don''t recognize Great as a reference comparison. They don''t know what they don''t know. Someone good knows how much more there is to learn.

You clearly want the best for your patients. Lucky them. Don''t let it get to you. Just do your best. Best wishes.