Put Vytorin back—way back—on the shelf

Last month, Merck/Schering Plough Pharmaceuticals finally released the disappointing results of a clinical trial, completed nearly two years ago, on the hoped-for ability of Vytorin to halt the progression of thickening in the carotid arteries (the two major blood vessels in the neck). In the interim, with the public totally unaware of those results, Vytorin continued to be heavily advertised to the public and widely prescribed by physicians.

That two-year study of 720 volunteers with inherited very high cholesterol levels, showed no significant differences between the carotid artery scans of those patient who took Vytorin (a combination of Zocor and Zetia) and those who took Zocor alone, despite the finding that the Vytorin takers had lower LDL cholesterol levels.

I think this study has two important implications, over and above the money wasted on purchases of Vytorin:

1. There's no connection between the lowered LDL cholesterol levels and the lack of change in carotid artery thickening (actually the Vytorin group had more plaque formation which was not, however, statistically significant). This is unlikely in view of the overwhelming evidence that ties LDL cholesterol to cardiovascular disease. Perhaps the study was not long enough.

2. There is fallibility in clinical studies that use so-called intermediate end-points (imaging techniques, biochemical changes) instead of real events (heart attack, stroke, death). There are still many unknowns about the causes of heart attacks; fully half of coronary-disease deaths occur in people with no discernable risk factors.

And what about the patients and professionals who believed the TV ads and the hype of the drug reps and spent large sums of money on a drug that was very likely not helping them?
Here's my advice:

Regard Zetia for what is—excessive and expensive baggage and a relatively weak LDL cholesterol lowerer. It should only be used by those who cannot tolerate statins or by the few patients who are already on high-dose statin therapy and are not achieving desirable LDL cholesterol levels. As for the combination product Vytorin? Put it back—way back—on the shelf and stick to a statin drug, preferably one available as a less-costly generic version. Read our CR Best Buy Drug report on statins to see which ones we recommend.
—Marvin M. Lipman, M.D.

Dr. Lipman has been Consumers Union's chief medical advisor since 1967. He is a diplomate of the American Board of Internal Medicine (certified in endocrinology and metabolism) and is clinical professor of medicine emeritus at New York medical College.