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Cholesterol and Cholesterol Drugs

The TVClubHouse: General Discussions ARCHIVES: Jan. 2008 ~ Mar. 2008: Health Center: Cholesterol and Cholesterol Drugs users admin

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Herckleperckle
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11-20-2003

Sunday, January 20, 2008 - 12:06 pm   Edit Post Move Post Delete Post View Post Send Herckleperckle a private message Print Post    
The Vytorin fuss is explained in this Wall Street Journal article:


Wall Street Journal
Style/Home Section: Pages D1 & D3
Thursday, Jan 17, 2008


Cutting Through the Confusion
Over Vytorin

Despite Negative Study, Doctors Say Drug Remains An Option to Fight Cholesterol

by Ron Wilson

"Patients are swamping doctors' offices wondering if they should stop taking the anticholesterol drug Vytorin, in the wake of a report questioning its ability to slow the progression of heart disease.

The message from many heart experts: Don't panic.

Despite high-profile news coverage and the widely quoted views of a prominent cardiologist, the study's findings offer only limited new information--at best--to influence whether patients should take the drug. And the study, known as Enhance, offers no clear signals that patients should stop using Vytorin.

'Enhance is not an alarming study,' says Richard Milani, head of preventive cardiology at the Ochsner Clinic, New Orleans. 'There were no safety issues related tot he trial that people were somehow being harmed on Zetia.'

The main finding was that Vytorin, which is marketed by a joint venture of Merck & Co. and Schering-Plough Corp;, failed to prove more effective than a cheaper generic drug in stanching the development of disease in blood vessels in the neck.

Vytorin and its sister drug, Zetia, are widely used to help patients lower LDL, or bad cholesterol, beyond levels achieved using popular cholestrerol pills called statins. Vytorin is a combination of Zetia and a statin. The statin, Zocor, is now available as a generic pill called Simvastatin.

The American College of Cardiology Tuesday issued an unusual statement cautioning doctors and patients against making decisions based on Enhance findings. The statement said Vytorin and Zetia remain 'reasonable' options in certain situations to help patients reach recommended cholesterol goals to reduce heart-attack risk. The college, the leading professional society for cardiologists, issued the statement after members reported they were getting calls from worried atients. One practice said it received 500 calls, said James Dove, president of the college.

The statement stood in contrast ot the position of Steven E. Nissen, chairman of cardiovascular medicine at the Cleveland Clinic and past president of the college, who was widely quoted urging doctors to stop prescribing the drugs for patients except as a 'last resort.' Dr. Nissen said the lack of efficacy found in the study suggested that the drugs had no beneift.

Dr. Nissen said his views and the college's are consistent in advising use of the drugs only when doctors and patients have exhausted their options with statins. But, he said, 'Here we are, six years after this drug was marketed and promoted with a massive marketing campaign and has become a $5 billion drug' without evidence it works as well as a statin. Now, 'the first trial we have, is reported much too late and doesn't really show any evidence of benefit.'

Patients and many practicing physicians are caught in the controversy, uncertain what course to take. Following are some key issues raised by the Enhance study.

What did the study show?
The 720-patient study indicated that patients taking Vytorin reached LDL levels 17% lower than those taking Zocor alone but derived no benefit as measured by the buildup of disease-causing plaque in their carotid, or neck, arteries. That measure is a commonly used surrogate marker for risk of heart attacks and stroke. There was a very small increase in the thickness of the arteries among Vytorin patients.

The data were released by the drug companies in a news release, not in the more standard form of an abstract or peer-reviewed published article. As a result, details about the safety and effectiveness of the drug remain unclear.

'It's premature to use this study to change how an entire nation is prescribing medication,' says Kevin Graham, president and head of preventive cardiology of Minneapolis Heart Institute in Minnesota.

If LDL was lower, why isn't there a benefit from Vytorin?
It isn't clear. Zetia reduces LDL cholesterol by blocking absorption in the gut, unlike statins, which inhibit its production in the liver. Dr. Nissen and other researchers believe this different mechanism may not have the same impact on the bilogy of the arteries or other factors that could prevent heart attacks. In any event, researchers agree that the findings don't undercut the prevailing view that lower is better when it comes to LDL.

If the drug doesn't prevent heart attacks, why is it on the market?
The drug was approved by the Food and Drug Administration based on its ability to lower LDL. As is typically the case with many drugs, including those for blood pressure and diabetes, the agency didn't demand proof that using the drug actually reduced the risks of heart attacks or stroke.

The Enhance results are now part of a larger debate over what kind of evidence the FDA should require before approving a drug. Studies that answer questions about heart attacks, strokes and mortality take many years, thousands of patients and lead to prolonged delays getting a drug to market. Looking at a proxy, like LDL, allows a cheaper, faster--albeit less definitive--trial.

Who should take the drugs?
Many doctors say the finding don't change the dominant view that Zetia or Vytorin should be used ONLY for patients who can't tolerate statins, or who don't get to aggressive goals on a high-dose statin alone. It shouldn't be used as a first-line treatment. Dr Nissen believes that with nearly one million prescriptions a week, the drugs are being inappropriately prescribed for many patients who haven't given statins a true test.

'Physicians should be using higher doses of statins long before they go to adding a drug where we don't have any evidence showing' it improves a patient's chances to avoid a heart attack or strok, says Paul Ridker, preventive cardiologist at Brigham and Women's Hospital, in Boston.

But Neal Shadoff, a cardiologist at Presbyterian Heart Group, Alubuquerque, N.M., says doubling the dose of a statin gives patients only an additional 6% reduction in LDL, while Zetia offers a 15% to 20% drop. He remains convinced the lowering LDL is the goal. While he primarily relies on statins, he believes Zetia and Vytorin are important tools in helping patients get to their goals.

Are better data on the way?
A study called Improve-It, being led by doctors at Harvard and Duke universities, is underway to see if Vytorin reduces heart attacks, strokes and death. Data aren't expected until 2011.

'This Enhance trial is just a reminder that you don't know until you've done the definitive trial,' says Duke's Robert Califf.