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A new study in the New England Journal of Medicine is raising questions about the safety of niacin for reduction of cholesterol in combination with another drug, laropiprant, designed to reduce facial flushing brought on by niacin. / Bloomberg via Getty Images

Niacin, a drug commonly prescribed to prevent stroke and heart attack, appears to add little benefit to the statins it is usually taken with, but it may cause significant risks, according to a new study and editorial in The New England Journal of Medicine.

As many as one in 200 patients may have died as a result of taking the combination of niacin and laropiprant, a drug intended to reduce the facial flushing caused by niacin, the study found.

"In the context of seeing no benefit (from the drug), the safety profile is very concerning," said Donald Lloyd-Jones, a cardiologist and chairman of the department of preventive medicine at Northwestern University's Feinberg School of Medicine in Chicago, who wrote an accompanying editorial about the study. "This medication really is not something we should be using routinely in clinical practice."

Niacin has been used for decades because it reduces the levels of "bad," or LDL, cholesterol and increases levels of "good," or HDL, cholesterol while also lowering triglycerides (blood fats) and blood pressure.

But while niacin drives patients' numbers in the right directions, the new research shows that statins alone do just as good a job of preventing heart attacks and strokes, said Lloyd-Jones, adding that he earns no money from the statin industry. The new study is the first that is large enough - with more than 25,000 patients - to really show niacin's limitations, he said, although a smaller study was stopped three years ago because of similar concerns.

In addition to a 9% increased risk of death - which fell short of being significant, so might have happened by chance - the niacin-laropiprant drug combination was also associated with gastrointestinal, musculoskeletal, infectious, bleeding and diabetes-related side effects, the study found.

Although bad cholesterol, triglyceride and blood pressure numbers are a danger sign, researchers have learned that medicating people to reach a target number doesn't necessarily prevent strokes and heart attacks, said Robert Eckel, a professor of medicine at the University of Colorado School of Medicine, and a past president of the American Heart Association.

"It's important to realize that HDL has not proven to be a target for therapy," he said.

Eckel said he thinks many doctors are comfortable prescribing niacin because it's been around so long.

According to a 2009 study published in the journal JAMA Internal Medicine, nearly 700,000 Americans are prescribed niacin every month, at a cost of more than $880 million a year.

But Eckel said he now thinks niacin should only be considered as a fourth-line therapy, after statins, and other cholesterol-lowering drugs, such as bile acid resins and Zetia, have been tried.

Both Eckel and Lloyd-Jones said too many people try one statin, have some problems, and think that they can't tolerate statins. Instead of quickly giving up on the most effective drugs on the market, patients should first give other statins and different doses a try, Lloyd-Jones said. Only about 5% of patients are truly statin intolerant, he said.



Copyright 2014USAToday

Read the original story: Niacin could have risks as cholesterol therapy

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