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New Questions and a Few Answers on Vytorin and Cancer Risks

An analysis published online by the New England Journal of Medicine sheds new light on the cancer risks of intensive lipid-lowering therapy with simvastatin and ezetimibe (Vytorin). The SEAS trial found that this combination was associated with increased cancer incidence, while pooled data from SEAS and two ongoing Vytorin studies found an increased risk for cancer mortality but not cancer incidence.

As first reported last month, cancer incidence in the SEAS trial of Vytorin in patients with aortic stenosis was higher in those receiving simvastatin and ezetimibe (11.1%) compared with those receiving placebo (7.5%).

A separate team of researchers pooled data from SEAS with two ongoing manufacturer-sponsored Vytorin studies. Patients receiving Vytorin in the pooled analysis had no increased risk for cancer incidence but did have an increased risk for cancer mortality.

Editorialists warn that "[the] increase in cancer mortality with ezetimibe should not be assumed to be a chance finding until further data are in." Writing in Journal Watch Cardiology, Harlan Krumholz points out that no trial has demonstrated improved cardiovascular outcomes with ezetimibe, and concludes that "For now, clinicians and their patients who use this drug should be aware that some uncertainty remains about its effects on patient outcomes."

LINK(S):

NEJM cancer study (Free)

NEJM SEAS study (Free)

NEJM editorial (Free)

Journal Watch Cardiology summary of cancer study (Free)

Journal Watch Cardiology summary of SEAS (Free)

Physician's First Watch coverage of FDA investigation of SEAS data (Free)

Published in Physician's First Watch September 2, 2008