Merck’s Worldwide Drug Suspension

Merck, one of the largest pharmaceutical companies, has announced that they are going to suspend the worldwide availability of Tredaptive (niacin/laropiprant). This announcement came after the European Medicines Agency (EMA) made a recommendation that it should no longer be marketed in Europe.

Preliminary results of the HPS2-THRIVE were poor and thus the EMA made a decision off those results, which it announced in December.

The test group participants that consumed Tredaptive plus a statin saw that while HDL increased, LDL was lowered. Vascular events such as coronary deaths, nonfatal heart attacks, stroke or revascularizations had a similar rate as those participants in the control section that took only the statin.

Test subjects that took the niacin drug, it was discovered, had a statistical significant increase in certain incidence of various types of nonfatal serious adverse events that were compared with those that only took statins.

To get the test done, it incorporated 25,673 patients that were considered to be at high risk for cardiovascular events, some in other countries (14,741 in Europe and 10,932 in China.) Researchers followed the patients for an average period of close to 4 years.

An interesting fact that medpagetoday cites is that Tredaptive was approved in Europe in 2008, in United States, the story was different that year, the FDA declined its use.

When the results of the AIM-HIGH trail were presented at an American Heart Association meeting in November 2011 in the U.S., the results were not favorable either. With the trial, niacin boosted HDL without reducing events that were compared to the statin alone. What was also discovered was that AIM-HIGH also had a signal of increased ischemic stroke – this evidence however was not significant in the final analysis.

Physicians and researches still, according to the medical publication, have high hopes that niacin could be used as means to increase HDL, however they would have to wait for the test results of HPS2-THRIVE.

Not all results have been negative. In 2010, anacetrapib, an HDL-boosting drug, showed that the third phase of trial was able to raise HDL without increasing vascular events. More tests are expected to be taken but data for them is not going to be available for a few more years such as the REVEAL trial.

If your doctor has given you an outdated drug and as a result you have been injured, contact our personal injury lawyer. You may be entitled to compensation!