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Elizabeth Trotta
Uncertainty lingers for cholesterol drug Vytorin, as experts gave mixed opinions about the cancer risks for the Schering-Plough (SGP Quote) and Merck (MRK Quote) joint venture in a prestigious medical journal.
The New England Journal of Medicine on Tuesday published results from one study that showed an increased incidence of cancer, but another, larger number-crunching effort showed that the number of cancer cases coming up in Vytorin studies vs. control groups was not statistically significant.
The SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) trial compared Vytorin -- a melding of a cholesterol lowering statin and Zetia -- with a placebo with respect to the incidence of cardiovascular events in older people with aortic-valve stenosis. The drug didn't have an effect on the narrowing of the aortic valve, and the trial didn't meet its primary endpoint, a reduction in major cardiovascular events.
On the plus side, it did lower "bad" cholesterol and meet some secondary endpoints, such as a reduction in "atherosclerotic events", like nonfatal heart attacks and cardiovascular deaths in high-risk patients.
But a statistically significant -- but unexpected -- increase in the incidence of cancer in the Vytorin group vs. the placebo group sparked alarm. The group using Vytorin produced 105 patients with cancer, compared to 70 in the control group. There also were also more deaths from cancer in the Vytorin group, 39 vs. 23, which just made statistical significance with a p-value of 0.05.
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