Doctors Divided Over Loss of Experimental Cholesterol Drug

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Pfizer said it has asked that all clinical investigators conducting trials warn patients to stop taking the drug immediately.

According to Pfizer spokesman Paul Fitzhenry, in a trial of 15,000 patients, 82 of those taking the combination of torcetrapib and the statin Lipitor had died, compared to 51 deaths among those taking Lipitor alone. Pfizer said the study did not raise any questions about Lipitor's safety.

There had been concerns about torcetrapib, which was designed to be taken with a statin like Lipitor, because a recent study showed it triggered a slight increase in blood pressure.

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But only last week, Pfizer had announced its intention to file an application with the U.S. Food and Drug Administration for approval of torcetrapib by the second half of next year. The company had expected to sell torcetrapib in combination with Lipitor, which is the company's -- and the world's -- best-selling drug.

LDL cholesterol is worrisome because if too much circulates in the blood, it can help to form plaque -- a thick, hard deposit that can clog arteries. This can lead to the creation of clots that can cause heart attacks or strokes. HDL cholesterol is beneficial because it carries cholesterol away from arteries and back to the liver, where it's passed from the body, according to the American Heart Association.

One remaining question is whether the finding on torcetrapib represents a so-called "class effect," because there are other, similar drugs currently in various stages of development.

"We have no idea if this effect will extend to other drugs in the class," Gibbons said. "We've learned from experience that it's incorrect to extrapolate the findings from one drug to another. This drug is in a different class than any of the drugs currently used by patients, so patients currently taking cholesterol-lowering drugs should not be concerned by the findings of this study. They should not decide they should not take existing therapies."

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