Video: Popular heart drugs don’t appear to help

  1. Closed captioning of: Popular heart drugs don’t appear to help

    >>> research and development .

    >>> well, there's a new study just released that raises questions about popular cholesterol lowering drugs vytorin and zetia . cnbc pharmaceutical reporter mike huckman is live at the american heart association where doctors just heard this presentation and, mike, it is all the talk today.

    >> it's definitely creating a lot of buzz here in the hallways where you mentioned just within the last hour researchers have finally presented this highly anticipated cholesterol drug study result to thousands of doctors who were in a big, crowded, almost standing room only hall here at the american heart association meeting in orlando. now, the reason there is so must interest in this is because an estimated 9 million people in the united states took the cholesterol fighting drugs called zetia and vytorin last year but this new study shows a new drug niaspann cut dangerous plaque and vytorin and zetia did not and the patients on zetia had significantly more heart attacks and strokes and five cardio related deaths in the zetia group and the top cardiologist at the cleveland clinic said this should change doctors prescribing habits.

    >> this study was, in fact, relatively well done. can you pick apart any study? of course you can. was there flaws? there's never been a perfect study. yes, the vast majority of us do believe these results.

    >> dr. nissin says he has not been paid any money by the drug company . joining me now for the other side is the president of global human health for public health . mr. ken frasier , thank you for being here.

    >> thank you for having me.

    >> your take on these results.

    >> i think it's important to put this study into the broader context. this was an extremely small study. less than 200 patients and many of the patients dropped out because they couldn't tolerate the medicine.

    >> because it causes flushing.

    >> because it causes flushing. in fact, that's the problem in the real world is patients can't tolerate this drug very readily. but what it was was a study that was not designed to determine clinical effectiveness. that was agreed by the entire panel, including the study author. this was a study that was designed to study whether there was a change in arterial thickness as judged by this one methodology.

    >> hey, kenneth, this is nancy snyderman . i have a question for you. i know this is a small study but a cumulative issue here now regarding the two medications. does it raise the question that perhaps we're looking at the wrong markers that inflammation is perhaps something we should zero in on?

    >> well, i think it's important to talk about what we know. we know from lots of evidence over decades that lowering ldl cholesterol decreases cardio cardiovascular risks. we know that with statins you can lower many patients but more than 50% of them don't reach their treatment goals. the marker that was used in this study is one that hasn't been proven to link to clinical outcomes. so, i think it's important to stick with what we know.

    >> mike, you said something earlier that really hit me and that is the presentations being over, what have you heard from physicians who heard that report and do you think it will change prescribing?

    >> what i've heard from people this morning, particularly in the hall is that we have to be careful to distinguish findings that relate to this clinical marker from findings that actually reflect on the effectiveness of vytorin and zetia . in fact, when this was published in the new england journal two editorials that accompanied it that made the point that this does not allow physicians to reach firm conclusions about these two medicines. it's very important for patients to understand that. they should stay on their medicines. if they have issues, they should talk to their physicians, but none of this suggests that there's any issue with the clinical efebiveness of these drugs.

    >> ken frasier . the president of global human health at merck and, dr. nancy, i should add that more than $4 billion, $4 billion worth of zetia and vytorin sold in the u.s. last year, this is a very big product for merck.

    >> mike huckman, thanks so much and kenneth frasier for taking the time to stop with you in the hallway.

    >>> now too, the swine flu .

updated 11/16/2009 11:35:55 AM ET 2009-11-16T16:35:55

A new study raises fresh concerns about Zetia and its cousin, Vytorin — drugs that are still taken by millions of Americans to lower cholesterol, despite questions raised last year about how well they work.

In the study, Zetia failed to shrink buildups in artery walls while a rival drug, Niaspan, did so significantly. Zetia users also suffered more heart attacks and other problems although the numbers of these events are too small to draw firm conclusions.

"This study provides no evidence that would reassure us that this drug is beneficial, and it provides some evidence that it may be harmful," said Yale University cardiologist Dr. Harlan Krumholz, who had no role in the study.

The results, being presented Monday at an American Heart Association conference and published online by the New England Journal of Medicine, are likely to move more doctors away from prescribing Zetia and Vytorin.

Statins such as Lipitor and Crestor have long been used to lower LDL, or bad cholesterol, and are known to cut the risk of heart problems. Nevertheless, many statin users still suffer heart attacks, so doctors have been testing adding a second medicine to further lower risk.

One they are trying is Niaspan, a slow-release version of niacin, a type of B vitamin that raises HDL, or good cholesterol. Another is Zetia, which lowers bad cholesterol in a different way than statins do, by blocking its absorption in the gut.

Vytorin is a pill that combines Zetia with a statin. Both are sold by Merck & Co. of Whitehouse Station, N.J. Niaspan is made by North Chicago, Ill.-based Abbott Laboratories. All three of these drugs cost between $3 and $4 a day, though niacin has been sold as a cheap generic for decades.

The new study was sponsored by Abbott, and several study leaders have been paid speakers or consultants to the company or to rival drugmakers.

Researchers enrolled 363 people with heart disease or a high risk for it who had been taking statins for six years on average. Many were from Walter Reed Army Medical Center, where study leader Dr. Allen Taylor formerly worked.

Study halted early
Half were given Niaspan and the rest, Zetia. Researchers stopped the study in June, after 208 participants had been on the medicines for 14 months, because one group was faring much better than the other.

Ultrasound images of neck arteries showed that Niaspan shrank buildups by about 2 percent, while Zetia had no effect on this even though it lowered bad cholesterol as expected.

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There were only two heart attacks, heart-related deaths or other heart-related problems in the 160 people given Niaspan, and nine among the 165 on Zetia.

"It should be better for the arteries and it wasn't. The drug wasn't operating as you otherwise would expect it to," raising concern that its effects are not fully understood, Taylor said.

Merck's research chief, Peter Kim, said the study and especially the number of heart attacks and other problems are too small to be conclusive. More than 25,000 people are in studies testing Zetia now, and independent monitors have found no problems that would lead them to stop the trials.

"We stand behind the safety of this drug," he said.

Drugs remain blockbusters
Last year, a large study found that the combo pill Vytorin was no more effective than Zocor alone, which is now available as a generic for a fraction of Vytorin's cost. In August, Merck and Schering-Plough Corp., its former partner in marketing Vytorin, agreed to pay $41.5 million to settle lawsuits claiming they delayed unfavorable study results on the drugs because they would hurt sales. Video: Study raises concerns about Merck's Zetia

The drugs remain blockbusters: Vytorin had nearly $2 billion in sales in the United States in 2008; Zetia, more than $1.5 billion, according to IMS Health, a health care information and consulting company.

However, that's down substantially: Zetia prescriptions fell 22 percent, from nearly 16.5 million in 2007 to less than 13 million in 2008. Vytorin fell 24 percent in that time, from about 22 million in 2007 to 16.5 million in 2008. Vytorin sales were down another 36 percent in the first half of this year.

Niaspan has been gaining but lags far behind — 5.8 million prescriptions in 2008, up 11 percent from 2007.

Its main drawback is a prickly hot sensation called flushing that many people find intolerable. The extended-release version is supposed to minimize this, but a third of study participants still suffered it. The problem tends to go away with longer use and can be blunted by taking the medicine with aspirin, at bedtime, or with a low-fat snack, doctors say.

© 2013 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.


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