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EU Agency Recommends Suspended Use of Niacin Products
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According to the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC), the risks associated with niacin/laropiprant products (TREDAPTIVE, PELZONT and TREVACLYN) are greater than the benefits, and the committee recommends suspension of use. These recommendations will next be considered at the Agency's next Committee for Medicinal Products for Human Use (CHMP) on Jan. 14 – 17, for final opinion. These products are not approved for use in the U.S. |
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Merck, manufacturer of the medicine, released a statement on Jan. 11 noting they will be taking steps to suspend availability of TREDAPTIVE worldwide, and will be working with regulatory agencies where the product is sold to develop communications for health care providers to ensure that patients have appropriate information. An earlier statement released on Dec. 20 from Merck, funder of the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study, noted that the study did not meet its primary endpoint, and providers are recommended not to start patients on TREDAPTIVE, an extended-release niacin/laropiprant. |
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"While we are disappointed in these results, we thank the investigators who have conducted the study and the patients who have participated in it," said Peter S. Kim, Ph.D., president, Merck Research Laboratories. "We are committed to working closely with the independent research team at Oxford University and with regulatory agencies to understand the results and determine next steps."
The study enrolled 25,673 patients considered to be at high risk for cardiovascular events who were followed for a median of 3.9 years, and compared extended-release niacin and laropiprant plus statin therapy versus statin therapy. According to the statement, the investigators found that "adding the combination of extended-release niacin and laropiprant to statin therapy did not significantly further reduce the risk of the combination of coronary deaths, non-fatal heart attacks, strokes or revascularizations compared to statin therapy." In addition, "there was a statistically significant increase in the incidence of some types of non-fatal serious adverse events in the group that received extended-release niacin/laropiprant."
"HPS-2 THRIVE was not, strictly speaking, a comparison of niacin + simvastatin (with or without ezetimibe) vs. simvastatin/ezetimibe + placebo," said William E. Boden, MD, FACC, chief of medicine, Samuel S. Stratton VA Medical Center in Albany, NY, and co-PI of the AIM-HIGH trial. "Laropiprant, as a prostaglandin inhibitor used with niacin to reduce the incidence of cutaneous flushing, could have caused some off-target effects that, in some way, could have neutralized/negated the clinical benefit of niacin in these patients. Given the uncertainty of laropiprant's clinical effects, one might have expected that the ideal statistical design for HPS-2 THRIVE would have been a 2X2 factorial design to examine the niacin + simvastatin effects separate from laropiprant."
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