Vytorin May Increase Cancer Risk
Long-term follow-up needed to clarify findings
TUESDAY, Sept. 2 (HealthDay News) -- Ezetimibe plus simvastatin (Vytorin) may be associated with an increased risk of cancer, according to two studies published online Sept. 2 in the New England Journal of Medicine and presented at the European Society of Cardiology Congress held Aug. 30-Sept. 3 in Munich, Germany.
In the SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) study, Anne B. Rossebo, M.D., from the University of Washington in Seattle, and colleagues randomly assigned 1,873 patients with asymptomatic aortic stenosis to 40 mg simvastatin plus 10 mg ezetimibe daily, or placebo. During a median of 52.2 months of follow-up, they found that similar percentages of patients in the treatment group and placebo group had a major cardiovascular event or aortic valve replacement. Significantly fewer patients in the treatment group had ischemic cardiovascular events but there were more cases of cancer.
In the second study, Richard Peto, from Oxford University in the United Kingdom, and colleagues examined the incidence of cancer in the SEAS trial and two others involving ezetimibe: SHARP and IMPROVE-IT. They found that while there was more cancer in the SEAS trial (101 patients versus 65 controls), there was no excess of cancer in the other two trials combined (313 versus 326, risk ratio 0.96). Ezetimibe treatment was linked to a nearly statistically significant increase in cancer deaths (97 versus 72) and a nearly statistically significant reduction in other cases of cancer (216 versus 254).
"The increase in cancer deaths shown in the patients taking Vytorin is very likely due to chance and not real," according to a comment issued by W. Douglas Weaver, M.D., president of the American College of Cardiology. "This study reinforces the need to adhere to our current Guidelines that say statins should be used first for patients with coronary artery disease. We await longer-term follow-up data from the other two much larger ongoing trials in order to completely answer the issue."
Merck and Schering-Plough Pharmaceuticals provided funding for the studies.