|ENHANCE trial results have caused reaction in the industry and on Capital Hill. Source: Cardionics|
Government and cardiovascular clinical leaders have been vocal this week in response to Merck and Schering-Plough Pharmaceuticals’ release of the results of the ENHANCE trial that found Vytorin is no more effective in treating patients who were genetically predisposed to having dangerously high levels of cholesterol than Merck's drug Zocor.
Vytorin contains Zocor, which recently lost patent protection and is now available generically as simvastatin, and a newer drug called Zetia. About 60 percent of patients who take Zetia take it with Zocor as Vytorin, according to USA Today.
The accusation that Merck and Schering-Plough was withholding the results caused Reps. John Dingell, D-Mich., and Bart Stupak, D-Mich., who chairs an Energy and Commerce subcommittee on oversight and investigations, to ask the companies to explain their delay in releasing data from the ENHANCE trial, completed in April 2006.
Dingell and Stupak on Wednesday sent letters to the FDA asking Commissioner Andrew von Eschenbach and executives of the drugmakers to turn over documents on the marketing campaign for Vytorin.
“Given the frequency of Vytorin advertisements, it concerns us that a study showing that Vytorin provides no increased benefit was not issued for nearly two years while direct-to- consumer advertisements were carried on the airwaves,” Dingell and Stupak said in a letter to the companies' CEOs. “This situation raises concerns that the drug companies and their advertisement agencies profited at the significant expense of patients' health,” the lawmakers said in the letter.
On the other hand, the American College of Cardiology (ACC) reported that the study deserves serious thought and follow-up. The overall incidence rates of cardiac events were nearly identical between both treatment groups, and both medicines were generally well tolerated, the ACC said. However, with three large trials comparing Vytorin to simvastatin will be published within the next three years, the ACC stressed that there “is no reason for patients to panic.”
Furthermore, the association advised “that Zetia remain[s] a reasonable option for patients who are currently on high dose statin but have not reached their lipid goals.”
The ACC also recommended that concerned patients using the drugs should talk with their healthcare professional. In a statement, the ACC said that this “is not an urgent situation and patients should never stop taking any prescribed medications without first discussing the issue with their healthcare professional. Further research will be needed in this area to provide conclusive evidence about which lipid lowering therapy is preferred.”
The ACC recommended that major clinical decisions not be made on the basis of the ENHANCE study alone.