UPDATE 1-Merck "good cholesterol" drug study wows doctors

Wed Nov 17, 2010 5:29pm EST

* Anacetrapib boots HDL levels 138 percent in study

* Doctors see potential to replace widely used statins

* Some heart doctors feel excitement may be premature (Adds link to main story)

By Ransdell Pierson and Debra Sherman

CHICAGO, Nov 17 (Reuters) - Merck's highly potent drug to raise heart-protective HDL cholesterol may give doctors a new sledgehammer against heart attacks and strokes, and be prescribed as often as the leading current statin treatments for heart disease, doctors said on Wednesday.

Thousands of doctors listened raptly earlier at midday as researchers presented findings from a highly anticipated study of Merck's drug, anacetrapib, at the annual scientific meeting of the American Heart Association in Chicago.

They were told that levels of HDL in patients taking the pill jumped 138 percent during the 18-month study, while levels of artery-clogging "bad" LDL cholesterol fell 40 percent. [ID:nN17220420]

Current HDL drugs, using niacin, only boost HDL by about 20 to 25 percent and aren't widely used because of side effects. The biggest family of cholesterol drugs, statins, focus on LDL -- cutting it by up to 60 percent. But they raise HDL by 10 percent or less.

"My bet is that anacetrapib will become as important as statin therapy, and might in some patients actually replace statins," said Dr. Patrick Couture, an internal medicine specialist at Laval University in Quebec City.

"If it is approved, it will become a blockbuster," Couture said at the heart meeting, "because so many patients at high risk of heart disease -- including those with obesity, metabolic disease and Type 2 diabetes -- all tend to have low levels of HDL."

David Gordon, a clinical trial specialist for the National Heart, Lung and Blood Institute, said he had been skeptical about anacetrapib because Pfizer Inc (PFE.N) pulled the plug on its similar torcetrapib in 2006 after it caused high blood pressure, blood-chemistry irregularities and a higher death rate in its pivotal trial.

"But I now think anacetrapib could be tremendously important," due to its profound elevation of HDL and simultaneous reduction of LDL, said Gordon. "There is nothing else like it."

Gordon and others streaming out of the heart meeting cautioned, however, that a bigger planned trial involving 30,000 patients must prove its safety and actual ability to reduce heart attacks and strokes beyond the approximately 25 to 30 percent reduction now seen with statins. The trial is expected to take at least four years.

"The numbers are unbelievable on the face of it, but we've been fooled before," said Dr. Chaim Gitelis of Maimonides Medical Center in Brooklyn, New York, of the anacetrapib results. "It might be too early to get too excited."

Dr. Ralph Stewart, a cardiologist at Greenline Cardiovascular Services in Auckland, New Zealand, hasn't yet forgotten the failed promise of Pfizer's torcetrapib.

"It's important to recognize we've been wrong plenty of times. It's a small study, but it's going in the right direction," he said. "It looks promising."

Dr. Martin Landray of Oxford University and a co-investigator of the planned larger anacetrapib trial, said: "What patients care about isn't a number, it's whether this drug will prevent them from having heart attacks, or whether it had bad side effects. Can the risk be reduced even more? We can't say, but we should know in 5 years." (Reporting by Ransdell Pierson and Debra Sherman; Editing by Gary Hill)

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