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Niacin Causes Serious Unexpected Side-effects, but no Worthwhile Benefits, for Patients who are at Increased Risk of Heart Attacks and Strokes
Date:3/9/2013

treatments (including effective statin-based cholesterol-lowering therapy) would produce worthwhile reductions in the risks of heart attacks, strokes or other cardiovascular outcomes.  Among those who took the ER niacin combination 13.2% suffered a heart attack, stroke or had an arterial procedure compared with 13.7% in those who took the dummy (placebo) tablets  ̶  a small but not clearly significant difference.

Side effects previously found with niacin, which were also seen in HPS2-THRIVE, included skin rashes, gastro-intestinal (stomach) problems, complications with the management of pre-existing diabetes and increased risk of developing diabetes. The newly identified side effects were infections and bleeding (particularly in the gut and brain), neither of which had been clearly demonstrated with niacin previously.

The results in HPS2-THRIVE are consistent with the results from other trials of ER niacin. For example, the AIM-HIGH trial of ER niacin alone (i.e. without the addition of laropiprant) in 3,400 high-risk patients was stopped prematurely after 3 years because no beneficial effects on heart attacks and strokes were seen. The known side effects of ER niacin were also seen in AIM-HIGH.  Further analyses of AIM-HIGH should be able to show if there are similar trends on bleeding and infections to those in HPS2-THRIVE.

The HPS2-THRIVE findings have resulted in the suspension by Merck & Co/MSD of the ER-niacin and laropiprant combination therapy from Europe and other countries where it had been approved for use. Although the combination therapy was not licensed in the US, regulatory authorities are now considering the implications of these results for the use of other forms of extended release niacin.

Principal Investigator Professor Jane Armitage , from Oxford University's CTSU, said: "The use of niacin for the prevention of cardiovascular events
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SOURCE CTSU Oxford University
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