January 28, 2013 - The Committee of the Pharmacovigilance Risk Assessment (PRAC) to the European he

January 28, 2013 - The Committee of the Pharmacovigilance Risk Assessment (PRAC) to the European hepatitis Medicines Agency (EMA), the risks associated with products containing niacin / laropiprant (Tredaptive, Pelzont and Trevaclyn) outweigh the benefits, and The Committee shall recommend the suspension. These recommendations will be evaluated in these days by the Agency's Committee on Medicines for Human Use (CHMP) for the final opinion.
The drug's manufacturer, Merck, has issued a statement on January 11 with which states that measures will be taken to suspend the Tredaptive all over the world, and will cooperate with the national regulatory agencies in order to put the current operators health care and ensure that patients have appropriate information.
In an earlier statement issued December 20 by Merck, financier of HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence hepatitis of Vascular hepatitis Events), it was also stated that the study did not meet its primary endpoint, and it was recommended not to start therapy with Tredaptive, niacin / laropiprant extended-release.
"Despite the disappointment at the outcome, we thank the researchers who conducted the study and the patients who participated," said Peter S. Kim, PhD, president hepatitis of Merck Research hepatitis Laboratories. "We are committed to working closely with the independent research group at the University of Oxford and with regulatory agencies to understand the results and decide how to proceed."
The study had enrolled 25 673 patients considered at high risk for cardiovascular events who were followed for an average of 3.9 years, and compared treatment with extended-release niacin and laropiprant more statins compared with statin therapy alone. According to the statement, the researchers found that "add the combination of extended-release niacin and laropiprant to statin therapy has not significantly reduced the combined risk of coronary death, nonfatal myocardial infarction, stroke, or revascularization, compared to statin therapy." In addition, "it was found a statistically significant increase in the incidence of certain types of serious hepatitis non-fatal events in the group that received extended-release niacin / laropiprant."
"The HPS-2 THRIVE, to be precise, not comparing niacin plus simvastatin (with or without ezetimibe) vs. simvastatin / ezetimibe plus placebo," said William E. Boden, MD, FACC, Chief of Medicine at the Samuel S. Stratton VA Medical Center hepatitis in Albany, NY (USA), and co-PI of the AIM-HIGH trial. "Laropiprant, prostaglandin inhibitor used in combination with niacin to reduce the incidence of hot flushes, may have caused some off-target effects that, in some way, may have neutralized the clinical benefit of niacin in these patients. Given the uncertainty on the clinical effects of laropiprant, we would have expected for the HPS-2 THRIVE better setting statistical factorial hepatitis 2 2 in order to examine the effects hepatitis of niacin plus simvastatin separated by laropiprant. " Go to archive << back