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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

should now be reconsidered. The HPS2-THRIVE trial shows that niacin causes significant hazards and does not reduce the number of people suffering heart attacks and strokes when added to treatments, such as cholesterol-lowering statin therapy, which are known to be safe and effective. It's only by carrying out very large clinical trials that we can get clear answers on treatments like this."

With regard to the bleeding and infection, it seems likely that earlier studies of niacin were too small to detect these new side effects reliably.  "The lack of benefit with niacin in HPS2-THRIVE is consistent with the result in AIM-HIGH. Similarly the risks of the known side-effects of niacin are consistent between HPS2-THRIVE and the other trials.  Although it is a possibility that these new side effects are due to laropiprant rather than to niacin, we consider this to be unlikely," Professor Armitage said.

Oxford University's Dr Martin Landray , one of the other lead investigators, said: "We are disappointed that we have not been able to find a drug that helps patients further. However, it is just as important to find out about the hazards of a treatment, particularly for a drug as widely used as niacin."

THRIVE also reported last month in the European Heart Journal that there was an increased risk of myopathy in Chinese participants, which was seen particularly in patients who took niacin as well as simvastatin.  

Professor Armitage expressed her gratitude to all of the participants in the study. "Without their help we would not have been able to make this progress towards improving the care of people who have had, or are at risk of having, a heart attack or stroke," she said.

HPS2-THRIVE was funded by a grant to Oxford University from Merck & Co, who also provided the ER niacin/laropiprant and matching placebo tablets, as well as background simvastatin or ezetimibe/simvastatin combination. H
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SOURCE CTSU Oxford University
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