PETER ROST: PHARMA MARKETING EXPERT WITNESS. AWP, MEDICAL DEVICE EXPERT.: Vytorin and cancer: A theory moves from the blogosphere to the FDA

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Vytorin and cancer: A theory moves from the blogosphere to the FDA

Ten days ago a secret friend of mine wrote a very tantalizing post on GoozNews:

"The recent clinical trial showing ezetimibe (whose trade is Zetia and is part of the combination anti-cholesterol pill known as Vytorin) may have increased cancer incidence and deaths has sparked interest in possible causes. The trial -- known as the SEAS trial -- was an effort to show the combination pill reduced heart disease. Ezetimibe is unique in that it inhibits cholesterol absorption (as opposed to removing cholesterol from the blood like statins). But ezetimibe also inhibits absorption of dietary plant sterols, and one plausible theory is that the reduction in sterol absorption in the patients in the SEAS trial may have increased their risk of contracting cancer."

Today the FDA announced, "FDA is investigating a report from the SEAS trial (Simvastatin and Ezetimibe in Aortic Stenosis) of a possible association between the use of Vytorin (a combination of simvastatin plus ezetimibe) and a potentially increased incidence of cancer."

The FDA also wrote, "FDA is aware of previous reports suggesting a link between low on-treatment cholesterol levels and an increased risk of cancer. A 2007 pooled analysis of 16 studies with 23 statin drug arms, published in the Journal of the American College of Cardiology, reported an association between the level of LDL-cholesterol achieved and incident cancer in patients receiving a statin."

Interesting stuff indeed.


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