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Adverse Effects in AIM-HIGH trial of Niaspan are Consistent With the Results Reported From HPS2-THRIVE Trial of ER Niacin Plus Laropiprant
Date:3/25/2013

of the AIM-HIGH trial which had tested the effects of adding extended-release niacin (Niaspan) alone on top of statin-based treatment. The AIM-HIGH trial involved similar types of patients but it was much smaller, involving 3,400 patients treated for only about 3 years, and it was stopped prematurely in 2011 because of no apparent benefit. In response to the request by the Oxford researchers, the AIM-HIGH investigators looked specifically at all reports of infections and bleeding. They provided analyses of the effects of Niaspan on these outcomes, which they reported to be consistent (albeit based on smaller numbers) with the excesses seen in the HPS2-THRIVE trial.

"This is a crucial bit of the jigsaw," said Professor Rory Collins , CTSU Co-Director. "When we saw our results, the obvious thing to do was to ask the AIM-HIGH team to look at their data for these two unexpected adverse effects, bleeding and infection, since AIM-HIGH had tested niacin alone. We look forward to collaborating with the AIM-HIGH investigators in assessing these hazards further."

Principal Investigator Jane Armitage said: "The consistency of the AIM-HIGH results on infection and bleeding with the results of HPS2-THRIVE, along with clues from the older literature about the effects of niacin, make us reasonably confident that these are niacin effects. In the light of these findings, we firmly believe that the use of all niacin products used to treat lipids should now be reconsidered."

Following release of the HPS2-THRIVE results, the European Medicine Agency announced that it is to review niacin and related substances; see web link below: (http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Nicotinic_acid/hu
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SOURCE CTSU Oxford University
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