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Niacin Clinical Trials Halted

So what should people on that drug do now?

If you are among the more than 1 million Americans taking high-dose, extended-release niacin along with a statin to control cholesterol, you might want to consult your doctor.

See also: A guide to treating high cholesterol.

With the federal government halting Niacin clinical trials, get patient advice on good cholesterol and increasing HDL levels

Dr. Mark J. Winter/Photo Researchers, Inc.

Niacin may not reduce risk of heart attack or stroke.

A bit of background: At the end of last month, the government ended a study 18 months early when an independent review panel determined that although niacin was raising participants' HDL, or "good" cholesterol, it was not reducing their risk of heart attacks or strokes.

News of the study's cancellation was the latest disappointment to heart experts trying to reduce patients' risks for cardiovascular disease, a leading cause of death in the United States, killing 800,000 Americans each year.

"It was quite a stunner," says Steven Nissen, M.D., chair of cardiovascular medicine at the Cleveland Clinic.

Even though Nissen acknowledges the use of niacin in the so-called AIM-HIGH trial "did not work," he says he is not ready to tell his patients to abandon the drug. Researchers are still collecting information about the results of the trial, he says, and there are other ongoing studies of niacin.

"Once the totality of evidence is in, we will know more," he says.

But Robert Eckel, M.D., a professor at the University of Colorado School of Medicine, says he found the preliminary results "convincing." He says he will advise patient to stop taking niacin if their medical profile matches those of the 3,400 study participants — those with a high risk of heart disease who are taking a statin drug to control LDL, or "bad" cholesterol and who have low levels of HDL and high levels of triglycerides — another fat in the blood.

"It appears niacin is being used unnecessarily by many people meeting these criteria," he says.

Cholesterol good and bad

LDL, low-density lipoprotein, delivers cholesterol to organs and tissues throughout the body. Too much cholesterol can build up inside blood vessels and eventually cause blockages. HDL, high-density lipoprotein, picks up the excess cholesterol and carries it back to the liver, where it is broken down; thus the higher the HDL, the lower the "bad" LDL in the bloodstream.

Next: Raising good cholesterol should make a difference. >>

But as the study reinforced, "No one ever felt better just because we changed their cholesterol level," says Nissen. "We want drugs that cause people to live longer, avoid heart attacks and feel better."

Researchers are describing the trial — sponsored by the National Heart, Lung and Blood Institute and Abbott Laboratories, which sells niacin as Niaspan — as an important reminder that reducing a person's "risk factor" does not always change the risk of having a heart attack or stroke.

"We know people with low HDL have a higher risk [for heart disease], but we don't know if we can do anything about it with pills," says Harlan M. Krumholz, M.D., professor of cardiology and health policy at the Yale School of Medicine. "That's a frustration for us."

For people running out of options, the decision to give up on niacin is not easy.

Stephen Berman, M.D., a 64-year-old Denver pediatrician, eats healthy and exercises vigorously every day — and still he underwent quadruple bypass surgery this year to fight progressive coronary artery disease, the same condition that ended his father's life at age 49.

"In the absence of a more definitive study," he says, "I think it's worthwhile for me to continue on niacin."

If your doctor has prescribed niacin with a statin, you may want to have a conversation about your medication.

You may also like: Eat for a healthy heart. >>

Jennifer Anderson is a freelance health and science writer.

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