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Merck Suspends Worldwide Sales of Tredaptive

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Baisha Kreuzer5 years ago

According to a report by Medpage Today, Merck, a major U.S pharmaceutical company, announced that sales of their cholesterol drug, Tredaptive (niacin/laropiprant), are being suspended worldwide by the recommendation of the European Medicines Agency (EMA).

Tredaptive has been approved in Europe since 2008, but was denied approval from the U.S. FDA that same year.

Why was Tredaptive Availability Suspended?

  • According to Medpage, the decision was made in response to results from the HPS2-THRIVE trial.
  • During the trial, participants taking Tredaptive along with a statin saw an increase in HDL (“good” cholesterol) and a decrease in LDL (bad cholesterol).
  • However, the participants had a similar rate of major vascular events, like coronary deaths, nonfatal heart attacks, strokes, or revascularizations, as those in the control arm.

More about the Tredaptive Study

  • The study involved 25,673 patients who were at high risk of cardiovascular events.
  • Of the total, 14,741 were in Europe and 10,932 were in China.
  • The patients were monitored for an average of 3.9 years.
  • Researchers determined that all participants had a similar rate of major vascular events and that those taking the niacin drug had a statistically significant increase in the incidence of some types of nonfatal serious adverse events compared with those taking only statins.
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