The cholesterol drug Vytorin has been in the news lately and it's not all good news.
Last week questions arose whether the drug did any good at all to lower cholesterol. Now the FDA says it will wait until after trial results are in before making a decision on the medications effectiveness.
Vytorin, a combination of cholesterol lowering drugs Zocor (simvastatin) and Zetia (ezetimibe) was studied by its makers. Called the Enhance study, it found Vytorin didn’t lead to less plaque in heart arteries compared to simvastatin alone. In fact, even though cholesterol was lowered, the deposit of artery-clogging plaques almost doubled in pace among patients taking Vytorin when compared to Zocor.
Don’t expect any action for at least six month as final trials come in and then the FDA has to fully evaluate the Enhance study results. The FDA could decide to alter is approach to approving lipid-lowering drugs.
A longer trial expected to last three years will compare Vytorin and Zocor’s affects on heart disease and stroke.
Merck/Schering-Plough Pharmaceuticals makes Zetia and Vytorin and has been criticized for sitting on the bad news while raking in billions in drug sales. The Enhance study was completed in 2006. The drug makers say they were taking extra time to evaluate the study results.
“While the Enhance trial was time-consuming and took longer than originally anticipated to complete, our companies acted with integrity and good faith in connection with the trial," Thomas Koestler, president of the Schering-Plough Research Institute, said in a prepared statement released Friday.
Patients looking to lower their cholesterol through drugs Lipitor might be a better choice say doctors. Dr. Harlan M. Krumholz, a professor of medicine at Yale University School of Medicine, says “this [Vytorin] is really a second-line drug,"
He tells Forbes, “We really should be guided by evidence, not marketing, and the evidence is really strong for statins. If lifestyles aren't sufficient to lower cholesterol, the next place they should go is statins. Only after those have failed should you go to the next step," he added, referring to Vytorin.
The Enhance study is not likely to enhance the bottom line of Merck.
A lawsuit seeking class-action certification was filed following the news that the company may have withheld data. Filed in Federal court in Seattle, lawyers allege drugmakers violated consumer protection laws by knowing that Vytorin was not more effective than other generic drugs in fighting arterial plaque and withholding that information for nearly two years.
And Senator Charles Grassley is asking Schering-Plough and Merck to explain when it first knew the results of the Enhance study. In a statement he says his constituents in Iowa have been paying about $112 per month for Vytorin while the generic -Zocor- sells for about half for a month’s supply. #