Vytorin, Zetia should be drugs of last resort, panel urges

The blockbuster drugs Vytorin and Zetia should be used only after all other cholesterol-lowering drugs fail until research proves that the medications work, a panel of heart specialists recommended.The panel, convened by the American College of Cardiology, based its assessment on detailed evidence from a controversial study showing that Vytorin worked no better than a statin drug now sold as a cheap generic.

"There is absolutely no difference … between the two treatment groups," said lead investigator John Kastelein of the Academic Medical Center in Amsterdam at the group's annual scientific session.The panel's spokesman, Harlan Krumholz of Yale University, said: "Our strongest recommendation is that people need to go back to statins. … If you were put on this drug before you were fully treated on a statin, you should go back."The study's results also were released online in the New England Journal of Medicine.

Both Zetia and Vytorin are made up of a drug, ezetimibe, that blocks the absorption of bad cholesterol, LDL, in the gut. Vytorin also contains the cholesterol-lowering drug simvastatin. "It was a disastrous outcome for this drug," says Robert Califf of Duke University, co-leader of an 18,000-patient trial called Improve-It, which will be the first to measure whether ezetimibe prevents heart attacks and deaths. The results are due in 2011.Enrico Veltri, a Schering-Plough vice president, said the trial in "no way changes LDL as a primary target of cholesterol therapy based on medical guidelines. We need to have treatment options available."

In a second study in the New England Journal, Krumholz and his co-workers examined prescribing practices in the USA, where a $200-million-a-year consumer advertising campaign helped build Vytorin and Zetia into blockbusters, and Canada, where direct-to-consumer advertising is banned.The promotion effort helped the drug capture 15% of the market for cholesterol-lowering drugs vs. 3% in Canada, the study found.

Steve - this is a follow-up to the news that broke several months ago. What drove us to tag this story was the last paragraph having to do with consumer advertising campaigns for drugs. Before Zetia and Vytorin were ever truly deemed safe and truly effective in long-term studies, their manufacturers flooded the market with advertisements, turning them into blockbusters almost overnight. Not only do consumer drug campaigns push the envelope in portraying them as "miracle workers," but puts tremendous strain on doctors who have to defend not prescribing them to consumers who desire them after watching the ads. The government has talked about taking action against these practices, but have not followed up the talk with any action.