Bad News for 'Good' Cholesterol Drug

Dec. 5, 2006 — -- It was supposed to be the next cholesterol wonder drug.

Many hoped its impact would be revolutionary, on par with cholesterol-busting statins in its lifesaving potential.

Now, the nation's top heart experts wonder whether hopes for HDL-boosting medicines can ever be revived following a trial exposing the risks of one such drug.

Drug giant Pfizer halted trials of Torcetrapib on Saturday after independent safety monitors discovered an unexpectedly high number of deaths with its use.

The drug is designed to raise levels of HDL -- commonly known as "good" cholesterol. Researchers believed this approach would complement that of drugs like statins, which lower LDL, or "bad" cholesterol.

The drug, which had been in development for almost 15 years, was in the midst of its largest, and final, clinical test when monitors noticed an increased death rate in those taking the drug.

Out of 15,000 volunteers in the study, 82 people taking Torcetrapib died, compared to only 51 people in the group not taking the drug.

"The higher mortality rate may be small in numbers of patients," said Dr. Christopher Cannon of the Center for Cardiovascular Disease Prevention at Brigham and Women's Hospital.

"But when we think about the tens of millions of people with heart disease who could potentially be treated by this drug. … That turns into a large number of patients who could be at risk," Cannon said.

Because the exact cause of the patient deaths in the trial is still unclear, it is too soon to tell whether other HDL-raising medications will be affected by Torcetrapib's failure.

The findings, however, represent a major blow to researchers who had high hopes for drugs designed to raise levels of HDL.

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Experts now wonder whether the HDL-raising strategy can be salvaged.

"This is a very sad outcome considering Torcetrapib's potential," said Dr. Melvyn Rubenfire, professor of internal medicine at the University of Michigan in Ann Arbor, Mich.

He added the approach "was the next major potential opportunity to reduce heart attacks, strokes and atherosclerosis."

"It's a huge setback," said Dr. Steven Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic Foundation in Cleveland.

"For patients already taking a statin, what can we offer them if they continue to have cardiovascular events? Not much," Nissen said.

Some experts were quick to point out, though, that despite Torcetrapib's failure, finding ways to raise HDL levels was still a promising area of research to combat cholesterol.

"I think it is terribly important to emphasize that this development says nothing about the overall strategy of targeting HDL therapeutically," said Dr. Daniel Rader, director of the Preventive Cardiovascular Medicine and Lipid Clinic at the University of Pennsylvania School of Medicine in Philadelphia.

Others said the failed trial might hint at problems to come if other similar drugs showed the same results.

"This marks a huge shift in the anticipated next step in the treatment of atherosclerosis," said Dr. Kevin Graham, director of preventive cardiology at the Minneapolis Heart Institute in Minneapolis, Minn. "The initial questions will focus on the mechanisms, whether this applies to all drugs of this class or whether it is particular to this drug. It is too early to say."