Clearing the confusion over Vytorin
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 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 to the 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 cholesterol 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 has issued an unusual statement cautioning doctors and patients against making decisions based on the Enhance findings. The statement said Vytorin and Zetia remain "reasonable" options in certain situations to help patients reach recommended cholesterol goals.
The college, the leading professional society for cardiologists, issued the statement after members reported getting calls from worried patients. One received 500 calls, said James Dove, president of the college.
The statement stood in contrast to 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." Nissen said the study suggested that the drugs had no benefit.
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 that it works as well as a statin.
The 720-patient study indicated that patients taking Vytorin reached LDL levels 17 percent lower than those taking Zocor alone but derived no benefit as measured by the build-up of disease-causing plaque in their carotid, or neck, arteries. That measure is a commonly used marker for risk of heart attacks and stroke.
There was a very small increase in the thickness of the arteries among Vytorin patients.
Zetia reduces LDL cholesterol by blocking absorption in the gut, unlike statins, which inhibit its production in the liver.
In any event, researchers agree that the findings don't undercut the prevailing view that lower is better when it comes to LDL.
Many doctors say the findings 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 first-line treatment.