The European Medicines Agency (EMA) has launched a review of nicotinic acid and its related substances acipimox and xantinol nicotinate after the publication of new data from HPS2-THRIVE. More results from HPS2-THRIVE are scheduled to be presented March 9 as a late-breaking clinical trial at the American College of Cardiology scientific session in San Francisco.
HPS2-THRIVE (Heart Protection Study 2—Treatment of HDL to Reduce the Incidence of Vascular Events) was designed to assess whether extended release niacin and laropiprant in addition to statins lowered low-density lipoprotein cholesterol in patients who are at high risk of major vascular events. In a recently published study, the authors reported that one-quarter of patients who received the niacin/laropiprant combination discontinued treatment, primarily due to adverse reactions. The niacin/laropiprant group had a fourfold higher risk of myopathy, and the risk was 10 times higher for patients in China compared with Europe.
“As the data from the HPS2-THRIVE study may have implications for medicines containing only nicotinic acid or related substances, the EMA will now assess the impact of the new data on the benefit-risk balance of these medicines, and will issue an opinion on whether the marketing authorizations for these medicines should be maintained, varied, suspended or withdrawn across the EU,” the agency announced March 7.
Merck, sponsor of HPS2-THRIVE, announced in December 2012 that HPS2-THRIVE had missed its primary endpoint, and in January, Whitehouse Station, N.J.-based company suspended the availability of nicotinic acid/laropiprant (Tredaptive) modified-release tablets worldwide.
The EMA contended that the data have 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. As a result, it recommended the suspension of medicines containing the combination of nicotinic acid and laropiprant across the EU.