The drug maker Merck announced on Thursday that a combination of niacin and another medicine failed to protect against heart attacks and strokes in a large clinical trial, and that the company would no longer pursue approval of the combination drug in the United States.
The trial, which followed more than 25,000 patients over four years, also found a statistically significant increase in the number of patients who suffered serious harm, although the company said those adverse events were not fatal. The patients studied were all taking statins, a class of drugs commonly used to lower bad cholesterol.
The results are likely to further tarnish the reputation of niacin, a drug that is often prescribed to raise the levels of good cholesterol in patients at risk for heart disease but that was found not to prevent heart attacks in a government study last year.
Merck's drug, called Tredaptive, combined an extended-release version of niacin with laropiprant, a medicine intended to reduce facial flushing in patients, one of niacin's more inconvenient side effects. Tredaptive is sold in about 40 countries, including in Europe, but it failed to win approval in 2008 in the United States.
In a statement, Merck said it was recommending that doctors not start new patients on the drug. The company said it would work closely with regulatory agencies "to understand the results and determine next steps."
Although the study did not determine that the negative results were because of niacin, the conclusions will probably further call into question whether patients should continue to be prescribed long-acting niacin, which is most commonly sold in the United States as Niaspan, made by Abbott. Niacin is a type of B vitamin that is considered a drug when it is taken in higher doses.
Last year, a study of more than 3,000 patients by the National Institutes of Health found that Niaspan offered no benefit over the use of statins alone.
"The failure strongly suggests that niacin simply does not improve outcomes for patients," said Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, who was not involved in the Merck study. He said he would continue prescribing niacin to patients who were already on it and faring well, but would probably not prescribe it to new patients until he could see more details about Merck's trial.
Another cardiologist, Dr. James A. de Lemos, said he would now recommend to patients using niacin that they stop taking it. He said that the study poked another hole in the once-promising theory that raising HDL, or "good" cholesterol, would lower a patient's risk of heart disease.
"This is the death knell for niacin, for sure, but it really raises questions about the whole HDL hypothesis," said Dr. de Lemos, a professor at the University of Texas Southwestern Medical Center, who was also not involved in the study.
Two experimental drugs that raised good cholesterol levels failed to prevent heart disease in earlier studies. Merck and Lilly are testing two other medicines that raise HDL more sharply than niacin, which works differently in the body.
Pam Eisele, a spokeswoman for Merck, said the results from the Tredaptive study have no impact on the outlook of anacetrapib, Merck's experimental drug. "We continue to believe that anacetrapib has the potential to be a significant innovation in lipid management," she said.
Dr. Nissen, who heads the trial for Lilly's drug, also cautioned against drawing overly broad conclusions. Each of the HDL-raising drugs works differently, he said. "HDL is exceedingly complex," he added. Sales of Niaspan were $634 million in the first three quarters of 2012, a 12 percent decrease over the same period in 2011, according to Abbott's quarterly report.
A spokeswoman for Abbott said the company was not familiar with the details of Merck's study but that it would evaluate results as they became available. "Physicians are best placed to determine the appropriate use for the product as they know the needs of their individual patients," said the spokeswoman, Tracy L. Sorrentino.
Merck, whose shares fell more than 3.4 percent in Thursday trading, said sales of Tredaptive were about $13 million over the first three quarters of this year.
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