Two of the world's bestselling drugs to lower cholesterol may have no benefit, researchers reported Sunday in a development that could significantly alter how patients are treated for heart disease. Based on the news, a top medical journal encouraged doctors to stop routinely prescribing them.
Vytorin and a related drug, Zetia, did not reduce fatty plaque in arteries any more than a cheaper generic, researchers said at a major cardiology conference in Chicago. Plaque, a buildup of cholesterol in the arteries, is believed to often play a key role in heart attacks and strokes.
In an online editorial, the New England Journal of Medicine recommended that until more research was available, patients should forgo using the drugs unless other medications such as statins or a better diet and more exercise fail to lower cholesterol levels in their blood.
Doctors said patients should not stop using the medicines without consulting their physicians. But specialists estimated that as many as two-thirds of the people currently taking the drugs may eventually be switched to other therapies.
The medicines, jointly sold by Merck & Co. and Schering-Plough Corp., were taken by more than 4 million patients in the U.S. last year and accounted for $5 billion in sales.
"What this tells us is that we have had far too many patients on these drugs than the science supports," said Dr. W. Douglas Weaver, a cardiologist and president-elect of the American College of Cardiology. "I suspect we will see a significant decrease in prescriptions."
The trial, known as Enhance, was finished in 2006 but the full results were not released until now. The surprisingly negative results are likely to fuel an already fevered debate over why it took so long for the drugs' two manufacturers to release the findings.
Critics may seize on it as evidence that the pharmaceutical industry is not keeping its vow to improve how it discloses clinical trial data. Two years ago, drug companies promised to register research trials in a public database and disclose outcomes as soon as possible. But there are few penalties for not complying.
Merck and Schering-Plough released partial results in January after media reports about the delay and a proposal late last year to change the trial's main research goal raised eyebrows. Making such a change after a trial gets underway would be highly unusual, and the proposal had some researchers worried that Merck and Schering were trying to undermine the scientific process.
