SEAS study may link Vytorin, cancer
September 2nd, 2008 by Kurt Niland
Today in Munich, Germany, researchers presented all of the data from the SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) study to the European Society of Cardiology. The SEAS study roused concern back in July when researchers revealed a possible link between cancer and the Zetia half of Vytorin.
The study, which monitored the progress of 1,873 subjects, found that 37 of the subjects taking Vytorin died of cancer, compared to 20 subjects who died of cancer while receiving a placebo. The data is rightfully alarming, but the study’s leaders maintain that it is a fluke. To support their claim, they point to two larger studies still in progress – SHARP and IMPROVE-IT. Numbers from those studies combined still show a higher rate of cancer among Zetia users, but only enough to be statistically irrelevant or at least inconclusive.
However, some professionals who are following the study, including a panel of doctors from The New England Journal of Medicine, argue that there is indeed a legitimate cause for concern, not the least of which that all three trials revealed more cancer in Zetia users. They also point out that Zetia “interferes with the gastrointestinal absorption not only of cholesterol but also of other molecular entities that could conceivably affect the growth of cancer cells.”
The other “molecular entities” include the tumor-fighting and cholesterol-busting superhero: plant-derived sterols. People ingest sterols every time they eat fruits and vegetables. Because Vytorin interferes with the body’s absorption of sterols, then it may, in theory, promote cancer.
The FDA expects to receive a final SEAS report in about 12 weeks. The agency anticipates it will take another 6 months to review and evaluate the study data, after which it will issue its conclusions and recommendations. In the meantime, the FDA has advised health care professionals to monitor their patients on Vytorin and to report side effects to the agency.