March 10, 2013
Failed Merck Drug Reveals Dangers Of Niacin-Based Heart Drugs
redOrbit Staff & Wire Reports - Your Universe Online
Trials of a failed Merck-developed, niacin-based drug designed to raise “good” cholesterol levels revealed serious side effects, raising red flags about the potential future use of such medications.
The drug in question, Tredaptive, was a combination of extended-release niacin and laropiprant, an experimental substance designed to help prevent facial flushing typically caused by the vitamin B derivative. The drug was designed to raise a patient´s high-density lipoprotein (HDL) levels.
After tests revealed Tredaptive was unsuccessful in preventing heart attacks and other cardiovascular events, Merck announced it would not seek approval for the substance in the US and would stop selling it internationally.
However, new information presented Saturday at the American College of Cardiology's (ACC) annual scientific meeting in San Francisco showed the problems with the medication were deeper than initially believed.
Those trials revealed patients taking Tredaptive experienced higher rates of bleeding (2.5 percent vs. 1.9 percent) and infections (8.0 percent vs. 6.6 percent) than those who were not taking it.
They also experienced other side effects linked with niacin use, including contracting new onset diabetes (9.1 percent vs. 7.3 percent), diabetic complications (11.1 percent vs. 7.5 percent) and gastrointestinal problems (4.8 percent vs. 3.8 percent).
“We are disappointed that these results did not show benefits for our patients,” Jane Armitage, professor at the University of Oxford and the lead author of the study, said in a statement, according to Matthew Herper of Forbes.
“Still, finding out a drug is not helping people is just as important as finding that it has benefits — the net result is that people are healthier,” she added. “Niacin has been used for many years in the belief that it would help patients and prevent heart attacks and stroke, but we now know that its adverse side effects outweigh the benefits when used with current treatments.”
In addition, Garret Fitzgerald, a professor of medicine and pharmacology at the University of Pennsylvania, told Herper the combination of the increased risk of infection, the diabetic complications, and the other side effects means the results of this trial likely spell “the death of niacin” as a cardiovascular treatment.
Likewise, Yale University cardiology and investigative medicine professor Harlan Krumholz said the findings were a “signal” to both doctors and patients that they should rethink using niacin-based drugs. “Can we afford to spend nearly $1 billion on a drug that has no benefit but now potentially has harm?” asked Krumholz, who is also a Forbes contributor.