Thursday, July 24, 2008

Vytorin: Dear Doctor Letter Readied

Vytorin is a drug made by a partnership of Merck & Schering-Plough. There's news that a letter has been readied to be sent to doctor who may be asking about recently released study results that showed patients taking the cholesterol drug were at higher risk of dying from cancer.

Video (less than 90 seconds)here:

From various sites:

The companies will take the stance that the increase in cancer deaths and higher incidence of cancer in a recent study involving 1,873 people should be considered an anomaly. The SEAS study were released this week, and it is in that study that the cancer connection is alleged. Source.

What is SEAS? It is the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) study. It is a randomized, multicenter, placebo-controlled study evaluating the effects of combination ezetimibe/simvastatin (Vytorin) on clinical outcomes in roughly 1800 patients with aortic stenosis, and the results showed that the controversial cholesterol-lowering medication was no better than placebo in reducing the primary composite end point of aortic-valve and cardiovascular events. (Link)

Other sites note this:

What Do the SEAS Results Mean?

There was speculation that the trial could help rehabilitate Vytorin after the Effect of Combination Ezetimibe and High-Dose Simvastatin vs Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE) trial was published in March, but the placebo-controlled trial design, as well as the patient population, were likely to limit the clinical impact.

The SEAS results are the first clinical results for Vytorin since ENHANCE was published. In that study, investigators tested the effectiveness of combined ezetimibe/simvastatin therapy in patients with familial hypercholesterolemia and found that the combination did no better than simvastatin monotherapy on several surrogate end points. The combination did not result in a significant difference in changes in intima-media thickness compared with simvastatin alone, despite significantly greater reductions in LDL cholesterol and C-reactive protein.(Link).