Thursday, November 17, 2011


Even as this year's AHA annual scientific meeting at Orlando, draw to a close, one of the most controversial trials presented must be the AIM-HIGH ( Atherosclerosis Intervention in Metabolic Syndrome with low LDL-C / high TG and Impact on Global Health Outcomes ) trial. This trial, led by Dr William Boden ( of COURAGE fame ), of 3,414 patients comparing the use of Niacin Vs placebo in patients with established CAD low HDL-C and high TG. These patients all also had simvastatin + ezetimide to keep their LDL-C low. This trial was prematurely terminated in May of this year by the FDA, before the unblinding because the data safety committee found no benefit in the treatment arm and a small increase in ischemic strokes in the treatment arm.
Well, at the AHA on 15th Nov., the full trial results were presented and also simultaneously published in the New England Journal of Medicine, online.

End points
Niacin (%)
Placebo (%)
HR (95% CI)
Primary end point
1.02 (0.87-1.21)
CHD death/ nonfatal MI/ ischemic stroke/ high-risk ACS
1.08 (0.87-1.34)
CHD death/ nonfatal MI/ ischemic stroke
1.13 (0.90-1.42)

There were also 27 ischemic strokes in the niacin arm and 15 in the placebo arm.
The increase in HDL-C in the niacin arm was minimal. Whether this was bacause niacin is not a good raiser of HCL-C or that the placebo arm's HDL-C was high due to the effect of simvastatin, was not discussed in the presentation.
The controversies was because some ( the pro-niacin camp), feels that the trial's conclusion that niacin does not much good and may do some harm was unfair, as the trial was underpowered from the beginning, and that adding simvastatin and a low dose of niacin, in the placebo arm ( to produce a mild flushing ) may have mask some of niacin's benefit. On the other hand, the trialist felt that they have done a good job, this is a negative trial, and the results should be accepted. Of course, the middle roaders will say that, for the moment, we should agree to disagree and await the completion of the THRIVE trial, a bigger trial to answer basically the same question.
For the moment, I will not ( I have not been ), use niacin to raise HDL-C in this group of patients.
At least this trial gave this years AHA some excitement.

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