Alert: Vytorin Controversy

Are you or someone you know taking Vytorin? Pharmaceutical companies Merck and Schering-Plough caused a scare this week when they released research results on the effectiveness of their cholesterol-lowering drug. Vytorin, which combines the traditional statin drug simvastatin with a newer type of cholesterol-lowering drug called Zetia, was found to be no better than simvastatin alone for reducing plaque buildup in arteries that run between the neck and brain. Study subjects had marginally more plaque buildup in these arteries when they took Vytorin instead of just simvastatin (the difference was not large enough to be statistically significant). Worse, Merck and Schering-Plough delayed the announcement of these results for close to two years.

If you or a family member or friend is taking a statin-alone drug, such as Zocar (simvastatin alone) or Lipitor, this study changes nothing. But users of Vytorin are likely -- and understandably -- concerned. Despite the frenzy surrounding the news, doctors are not of one mind regarding its significance. Some are alarmed, saying the drug companies have increased patients' risk of heart attack and exposed them to potentially dangerous side effects. But other medical professionals, including the American Heart Association, say the study was too small and left too many questions unanswered. "The artery-imaging technique used in the study tells us nothing about plaque stability or content, which are more indicative of heart attack risk," says Robert Eckel, MD, professor of medicine at the University of Colorado in Denver and former president of the American Heart Association. "This is not a definitive study, and nothing people should be basing clinical decisions on right now."

People are often put on Vytorin because other drugs have not lowered their cholesterol enough or caused problematic side effects. A bigger study, involving 10,000 subjects, is under way. "Patients on this combination drug should check with their doctor to see if they should stay on the drug, be switched to a statin alone, or take another combination of drugs for their cholesterol," says Daniel W. Jones, MD, president of the American Heart Association.

Originally published on LHJ.com, January 2008.