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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

OXFORD, England, March 25, 2013 /PRNewswire/ --

Senior researchers at Oxford University's Clinical Trial Service Unit welcomed today's statement by the Principal Investigators of the AIM-HIGH trial about the consistency of the adverse effects seen in the AIM-HIGH trial of extended-release niacin (Niaspan) with those reported from the HPS2-THRIVE trial of extended-release niacin given in combination with laropiprant (Tredaptive).

The findings of the HPS2-THRIVE trial of over 25,000 patients with pre-existing cardiovascular disease were presented by the Oxford University scientists at the American College of Cardiology (ACC) meeting in San Francisco on Saturday 9 March 2013. Adding extended-release niacin with laropiprant (which reduces flushing due to niacin) to effective statin-based cholesterol-lowering treatment failed to produce any clear benefits for these high risk patients. In addition, the expected side-effects of niacin were seen: skin rashes, gastro-intestinal (stomach) problems, complications with managing pre-existing diabetes and an increased risk of developing diabetes. Unexpectedly, however, there were also excesses of infections and bleeding (particularly in the gut and brain).

The very large randomised HPS2-THRIVE trial was able to show how frequent and how serious these expected and unexpected adverse effects were. On average, about 30 per 1000 patients treated for 4 years with the extended-release niacin/laropiprant combination suffered a serious adverse event - most of which required hospitalisation - due to the study treatment. But, since the HPS2-THRIVE trial tested the combination of extended-release niacin and laropiprant, it is not able to assess directly the separate effects of niacin and of laropiprant.

When the Oxford researchers first saw the preliminary results from the HPS2-THRIVE study, they contacted the Principal Investigators
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SOURCE CTSU Oxford University
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