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Niacin without the side effect

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Times Staff Writer

Researchers have reported the development of a new combination drug that will allow patients to take high doses of the cholesterol-lowering vitamin niacin without a painful and embarrassing side effect known as flushing.

Niacin has been shown to be an effective agent for lowering bad cholesterol, increasing good cholesterol and reducing cardiovascular risk, but three-quarters of those who take it discontinue use within a year because of flushing, which is characterized by a severe reddening of the skin.

Nearly half of the patients taking the highest dose of the new drug, called Cordaptive, had no flushing, compared with 22% of those taking a lower dose of a time-release version of niacin alone, said Dr. Michael J. Koren of the Jacksonville Center for Clinical Research.

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The improved tolerability “may prevent more patients from discontinuing therapy,” Koren said of his findings, which were presented Monday at a Chicago meeting of the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions.

Dr. Mason Weiss of Centinela Hospital in Inglewood conceded that “flushing is the biggest problem” with niacin, but cautioned that “you are going to have to have a much longer track record for me to use an additional medication.”

Weiss, who was not involved in the study, recommended simply reducing the dosage of standard niacin to avoid the side effect.

Dr. John Paolini of Merck & Co., which manufactures Cordaptive, countered that safety studies involving nearly 5,000 patients had shown no unusual side effects from the new drug, which is being reviewed by the Food and Drug Administration.

The flushing is caused by the niacin-triggered release of a prostaglandin, a hormone that causes dilation of blood vessels in the skin. It can be partially blocked by administering aspirin 30 minutes before taking niacin.

Cordaptive contains a newly developed drug called laropiprant, which blocks the prostaglandin more selectively.

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In the new trial, funded by Merck, Koren and his colleagues studied 1,455 patients with high cholesterol.

Half received increasing doses of Cordaptive until they reached niacin consumption of 2 grams per day, the most effective dosing level.

The other half received Niaspan, an extended-release form of niacin sold by Abbott Laboratories.

All were told about the benefits of aspirin. Twice as many patients in the Niaspan group reported using aspirin in an attempt to prevent flushing.

Over the 16 weeks of the study, patients receiving Cordaptive had an average of one flushing episode per month, while those receiving Niaspan alone had one per week.

Twelve percent of those receiving Niaspan quit because of flushing, compared with 7% of those receiving Cordaptive.

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thomas.maugh@latimes.com

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