This was quite a large trial with 25k patients followed over 4 years and some encountered serious harm, but Merck has not let us know yet what the “harm” was except that it was not fatal. All patients were also taking statins to reduce cholesterol. Tredaptive, the drug from Merck was a combination extended release of Niacin with laropiprant that reduces facial flushing in patients as that is a side effect of Niacin. Tredaptive is approved in other countries but did not make FDA approval in the US, so it looks like the FDA was on target here. Now Niaspan, made by Abbott will probably be questioned as well as the NIH found that it offers no benefit over just using statin drugs alone. BD
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.
Niacin is a type of B vitamin that is considered a drug when it is taken in higher doses. “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.