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Heart attack

Zetia, Vytorin reduce risk of repeat heart attacks

Karen Weintraub, Special to USA TODAY
Ezetimibe sold under the brand name Zetia by Merck.

Lower truly may be better when it comes to cholesterol, according to a new study that finds that adding another drug to a statin to bring down levels of LDL or "bad" cholesterol modestly helps recent heart attack victims.

The Merck drugs Zetia and Vytorin, which had combined worldwide sales of $3 billion so far this year, were shown to reduce the risk of repeat heart attacks or stroke by about 6%, according to the study, which is being presented today at the American Heart Association's annual conference in Chicago.

The study followed more than 18,000 people for an average of six years after a heart attack, and found that 50 people needed to take medication for one to benefit. Patients on Vytorin, which is a combination of ezetimibe (sold under the brand name Zetia) and the statin simvastatin, had an average LDL cholesterol of 54 mg/dL, compared with 69 mg/dL for those treated with just the statin.

The results of the trial have been eagerly awaited to resolve a bitter debate about the importance of lowering cholesterol, and whether a lower number equates to a lower risk of heart attack, stroke or death.

Dr. Christopher Cannon, who led the research, said the study shows that patients and doctors need to continue focusing on lowering cholesterol.

"This reminds us that the cholesterol story is true and that lowering cholesterol reduces heart disease," said Cannon, a cardiologist at Brigham and Women's Hospital and professor at Harvard Medical School, both in Boston.

Others drew different conclusions from the trial, nicknamed IMPROVE-IT, for IMProved Reduction of Outcomes: Vytorin Efficacy International Trial.

"The whole lesson we've had in the last 10 years is that some drugs that make your labs look better don't necessarily improve your outcomes," said Harlan Krumholz, a cardiologist at Yale University in New Haven, Conn.

Every drug has to be tested individually, he said, warning against drawing broader conclusions from a trial like this one. "These drugs have 1,000 effects and we're measuring one

But he said he was pleased to see that "the drug is safe and it has at least a modest benefit," which wasn't clear before, although doctors have written millions of prescriptions for Vytorin and Zetia, Krumholz said. "This is the result I'd hoped for."

The trial is also the first to show that a different type of cholesterol-lowering drug can improve upon statins. Statins reduce the amount of cholesterol made in the liver; ezetimibe blocks absorption of cholesterol.

"The past is littered with trials that adding anything to statins is not effective," said Dr. Patrick O'Gara, president of the American College of Cardiology and Cannon's colleague at Brigham and Women's and Harvard. Niacin, for instance, was long combined with statins because it helped raise levels of "good" or HDL cholesterol, but research last year showed that those numerical improvements failed to translate into fewer heart attacks and strokes.

The IMPROVE-IT results suggest that some combination treatments might be effective.

The other major question raised by the trial is whether it should be used to change treatment guidelines. Last year the American Heart Association and the American College of Cardiologists set new guidelines saying only that patients should be given statins, with no target numbers for LDL cholesterol.

Dr. Steven Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, said he thinks the guidelines should now be updated to say "get as low as you can without an adverse impact on patients."

But O'Gara said it would be premature to change medical practice based on a single study.

In the meantime, O'Gara said, he would consider putting his patients on Vytorin if they couldn't manage a full dose of statins.

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