EMA Launches Review of Nicotinic Acid on Eve of HPS2-THRIVE Late-Breaker
European Medicines Agency. Review of nicotinic acid and related substances started [press release]. March 8, 2013.
Available here.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referr...
LONDON — The European Medicines Agency (EMA) has launched a review of nicotinic acid "and related substances" in response to new data from the HPS2-THRIVE study [1]. The announcement comes on the eve of the late-breaking presentation of the full HPS2-THRIVE results at the American College of Cardiology 2013 Scientific Sessions.
According to an EMA announcement today, "The new data failed to show that the combination reduces the risk of major vascular events (such as heart attack and stroke), and a higher frequency of nonfatal but serious side effects was seen in patients taking the combination."