CHICAGO — Leading doctors urged a return to older, tried-and-true treatments for high cholesterol after hearing full results Sunday of a failed trial of Vytorin.
Millions of Americans already take the drug or one of its components, Zetia. But doctors were stunned to learn that Vytorin failed to reduce heart disease even though it worked as intended to reduce three key risk factors.
"People need to turn back to statins," said Yale University cardiologist Harlan Krumholz, referring to Lipitor, Crestor and other widely used brands. "We know that statins are good drugs. We know that they reduce risks."
The study was watched because Zetia and Vytorin have racked up $5-billion in sales despite limited proof of benefit. Two congressional panels launched inquires into why it took drugmakers nearly two years after the study's completion to release results.
Results were presented at an American College of Cardiology conference on Sunday and published on the Internet by the New England Journal of Medicine.
Doctors have long focused on lowering LDL or bad cholesterol as a way to prevent heart disease. Statins like Merck & Co.'s Zocor, which recently came out in generic form, do this, as do niacin, fibrates and other medicines.
Vytorin, which came out in 2004, combines Zocor with Schering-Plough Corp.'s Zetia, which went on sale in 2002 and attacks cholesterol in a different way.
The study tested whether Vytorin was better than Zocor alone at limiting plaque buildup in the arteries of 720 people with super high cholesterol because of a gene disorder. The results show "in no subgroup, in no segment, was there any added benefit" for reducing plaque, said Dr. John Kastelein, the Dutch scientist who led the study.
Merck and Schering-Plough said Sunday that they disagreed with the recommendations.
No one should ever stop any heart drug without talking with their doctors, specialists said.