Merck & Co.’s cholesterol drug Tredaptive, pulled from the market earlier this year, increased side effects like bleeding and infections and didn’t help patients, according to results of a clinical trial.
The study of 25,673 patients found Tredaptive failed to reduce the risk of stroke, death, heart attack or the need for surgery in people with vascular diseases. The drug combines the vitamin niacin, which studies suggest can help raise levels of good cholesterol, with the experimental medicine laropiprant, added to reduce a face-flushing effect of the vitamin.
The results of the study, called HPS2-THRIVE, could change the use of niacin, which is often used to supplement cholesterol-lowering drugs, said the study’s lead investigator.
“Niacin has been used for many years in the belief that it would help patients and prevent heart attack and stroke, but we know now that its adverse side effects outweigh the benefits when used with current treatments,” Jane Armitage, the study’s lead investigator and a professor of clinical trials and epidemiology at the University of Oxford, said in a statement announcing the results.
The data were presented today at the American College of Cardiology meeting in San Francisco. Patients in the trial were also taking a cholesterol-lowering medication.
Merck, the second-biggest U.S. drugmaker, said in December it wouldn’t seek U.S. approval for Tredaptive and stopped selling it globally in January. The medicine is approved in 70 countries and was sold in 40. Other results from the same trial announced in December showed that it didn’t cut the risk of the vascular events it was meant to prevent.
In the study, 2.5 percent of patients experienced bleeding while on Tredaptive, versus 1.9 percent of those getting a placebo. The rate of infections rose to 8 percent for those on the drug, compared to 6.6 percent on placebo. There were also higher rates of diabetes, complications from diabetes, gastrointestinal problems, and rashes or itching.
AbbVie Inc., the drugmaker that was split off from Abbott Laboratories at the start of this year, sells an extended-release form of niacin called Niaspan. The medicine sold $911 million in 2012.
Niacin failed to prevent heart attacks and may have boosted stroke risk in a U.S. government-funded study last year, called AIM-HIGH, which didn’t include laropiprant. It was criticized for being too small with 3,414 patients, though the new trial’s results appear to confirm it, Armitage said in the statement.