Even if I had another topic planned, how could I not writethis month about Zetia? Another example of panacea to panic, another billiondollar drug toileted based on preliminary studies. More than 4 millionAmericans taking this drug or the combination drug Vytorin (Zetia plus Zocor)now not sure what to do.
But what should users of Zetia and Vytorin do? It has beenwell established that lower LDL or bad cholesterol is good for the heart. Thesurprising finding of the ENHANCE trial was that in the groups that receivedZetia, despite significantly lower cholesterol, there was not a correspondingregression of plaques in the carotid arteries. Since carotid disease issomewhat predictive of coronary disease, this has raised red flags about theeffective- ness of Zetia at preventing heart attacks and disease.
But as usual, the misreporting of the ENHANCE trial in themedia has obscured several important facts about the drug itself. First andforemost, there have been NO studies yet about cardiac events. We simply don’tknow whether the regular use of Zetia as part of a strategy ofcholesterol-lowering leads to less clinical heart disease or not. Thoughcholesterol-based plaque clogging arteries is part of the problem, it is notthe whole story. Second, the study took place over two years, and long-termeffects on the arteries are not known. The conclusions based on thispreliminary information has quickly led to the trashing of a drug in the mediathat may still have important uses.
ENHANCE does bring up some of the intrinsic limitations ofcombination drugs. I have always been wary of combining two active chemicals inthe same pill because it may be difficult to determine which drug is doingwhat.
The real problem here is not with a drug that lowerscholesterol by blocking its re-absorption in the gut, but with the media’skneejerk attempts to marginalize this drug into non-existence based on apreliminary and limited study.
Marc Siegel, MD, is an internist and associate professor ofmedicine at New York University and the author of False Alarm: The Truth Aboutthe Epidemic of Fear
From the May 01, 2008 Issue of MM+M - Medical Marketing and Media
