- The Washington Times - Monday, March 31, 2008

CHICAGO (AP) — Leading doctors urged a return to older, tried-and-true treatments for high cholesterol after hearing full results yesterday of a failed trial of Vytorin.

Millions of Americans take the drug or one of its components, Zetia.

Doctors were stunned to learn that Vytorin failed to lower the risk of 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 Dr. Harlan Krumholz, referring to Lipitor, Crestor and other widely used brands. “We know that statins are good drugs. We know that they reduce risks.”

Results were presented at an American College of Cardiology conference in Chicago 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 became available in generic form, do this, as do niacin, fibrates and other medicines.

Vytorin, which was introduced in 2004, combines Zocor with Schering-Plough Corp.’s Zetia, which has been on the market since 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 genetic disorder.

The results show that the drug had “no result — zilch. In no subgroup, in no segment, was there any added benefit” in terms of reducing plaque, said Dr. John Kastelein, the Dutch scientist who led the study.

This was in spite of reports that Vytorin dramatically lowered LDL, other fats in the blood called triglycerides and a measure of artery inflammation called CRP.

Some doctors noted that hormone pills for menopausal women and torcetrapib, a promising cholesterol drug Pfizer Inc. has abandoned, also lowered cholesterol but were found in major studies to raise, not lower, heart risks.

Another ominous sign was the decision Friday by other researchers to expand enrollment in a more pivotal study of Vytorin to 18,000 people because early results suggest it will be harder than anticipated to determine whether it is any better than Zocor alone.

“It will be 2012 — 10 years after the drug was introduced — before we know the answer,” said Dr. Steven Nissen, a Cleveland Clinic cardiologist who has no role in the studies and has criticized the drug manufacturers over the results reported yesterday.

Dr. Robert Spiegel, chief medical officer for Schering-Plough, said the study was conducted “with the highest integrity” and that doctors can believe the results “because of the time we took to make sure the data are right.”

“We were disappointed that it was not a very balanced panel discussion” by the heart doctors who urged their peers to focus on more established treatments.

However, Dr. Kastelein said the data were far more consistent than anticipated and ample to show that the drug simply did not work.

“A lot of us thought that there would be some glimmer of benefit,” said Dr. Roger Blumenthal, a Johns Hopkins University cardiologist and spokesman for the American Heart Association.

LOAD COMMENTS ()

 

Click to Read More

Click to Hide