Merck Drug Fails Trial: Cholesterol Medication Raises Safety Concerns

A new study indicates that the Merck cholesterol drug Tredaptive fails to benefit heart disease patients.

The medication is a combination of niacin, which is considered a nutrient, and the drug laropiprant. When used together the ingredients are meant to increase positive HDL cholesterol while reducing certain side effects typically associated with niacin therapy. Taken alone niacin has been known to cause facial flushing in patients.

Reuters reports that HPS2-THRIVE, a major clinical trial of Merck’s Tredaptive medication, had unfortunate results. The study found that the drug does not decrease the risk of heart attacks, deaths, or strokes any more than traditional statin medications. Common statin drugs serve to lower negative LDL cholesterol.

Along with its failure to decrease heart risk, Merck states that Tredaptive “had significantly raised the incidence of some types of nonfatal but serious side effects” according to study results.

The clinical trial was conducted over a four year period and followed approximately 25,000 patients in Europe and China. Merck, manufacturer of the drug, revealed the study’s results on Thursday. There have recently been additional studies resulting in doubts as to the overall effectiveness of niacin in the treatment of heart disease.

Concerns have also been raised by the US Food and Drug Administration about the possible hearts risks associated with the use of laropiprant.

According to an article by NPR, Merck no longer plans to seek approval of Tredaptive by the US Food and Drug Administration. The drug’s approval status had been declined by the FDA pending review of the HPS2-THRIVE study.

It is not immediately clear if Merck will cease distribution of the drug overseas. According to Reuters, Merck reports 2012 sales of Tredaptive at approximately $13 million in the 40 countries currently selling the medication. Analysts had predicted annual sales to reach $300 million globally if the drug had passed domestic FDA approval.

Will you be affected by Merck’s cholesterol drug failing its clinical trials?