The results of a clinical trial show that Merck & Co.’s cholesterol drug Tredaptive increased side effects such as bleeding and infections, and did not help patients as intended.
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, Bloomberg.com reports. The drug combines the vitamin niacin, which studies suggest can help raise levels of good cholesterol, with the experimental medicine laropiprant, which reduces the face-flushing effect of the vitamin. In the study, 2.5 percent of patients experienced bleeding while taking Tredaptive, versus 1.9 percent of those getting a placebo. The infection rate rose to 8 percent for those on the drug, compared to 6.6 percent on placebo. Bloomberg.com reports that the researchers also found higher rates of diabetes, complications from diabetes, gastrointestinal problems, and rashes or itching.
Tredaptive is approved for use in 70 countries and was sold in 40, but not in the United States. In December Merck said it would not seek approval for Tredaptive from the U.S. Food and Drug Administration (FDA). The company stopped selling the drug globally in January.
Dr. Jane Armitage, of the University of Oxford, the study’s lead investigator, said the study results could change the way niacin is used, according to Bloomberg.com. “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,” Armitage, said in a statement announcing the study’s results. Patients in the trial were also taking a cholesterol-lowering medication.
The study results were presented at the March meeting of the American College of Cardiology in San Francisco.