29 May 2011

AIM HIGH media takeaway: don't take niacin

in the news this week: niacin study stopped early after lack of benefit found, and perhaps even negative benefit found.

e.g. this MSNBC headline states, "Niacin doesn't stop heart attacks, major study finds"

i read the press release. The second sentence of the press release is:

The trial found that adding high dose, extended-release niacin to statin treatment in people with heart and vascular disease, did not reduce the risk of cardiovascular events, including heart attacks and stroke.

we know straightaway that the combination of niacin with a statin (or two, depending on the subject) did not reduce cardiovascular events. the MSNBC article did state this in the body, so bad on them for sloppy headline writing.

further down in the press release:

The DSMB also noted a small and unexplained increase in ischemic stroke rates in the high dose, extended-release niacin group. This contributed to the NHLBI acting director’s decision to stop the trial before its planned conclusion. During the 32-month follow-up period, there were 28 strokes (1.6 percent) reported during the trial among participants taking high dose, extended-release niacin versus 12 strokes (0.7 percent) reported in the control group. Nine of the 28 strokes in the niacin group occurred in participants who had discontinued the drug at least two months and up to four years before their stroke.

Interesting. Twenty-eight strokes are being correlated with niacin intake, though they might consider counting only 19. I have to wonder if 12 vs 19 is statistically significant.

There were a couple pieces of information missing from the press release. I would like to know how many strokes there were in the control group, to compare against the 12, 19, or 28. I would also like to know the numbers for the other cardiovascular events. They were mentioned, but never enumerated, and MSNBC's headline writer either knows something not in the press release, or took some liberties.

I also noted this bit:
The niacin tested in the study is a proprietary formulation used in doses of 500-2,000 milligrams (mg), manufactured by Abbott Laboratories and approved and regulated by the U.S. Food and Drug Administration.

I thought Niaspan was simply niacin. perhaps "proprietary formulation" means nothing more than a manufacturing process -- and a way to patent an easily available vitamin -- but if it's anything other than straight niacin, i think that's relevant.

finally, this made me laugh:
Eligible participants were randomly assigned to either high dose, extended-release niacin (Niaspan) in gradually increasing doses up to 2,000 mg per day (1,718 people) or a placebo treatment (1,696 people).

I wonder if the placebo also caused a flushing effect. otherwise, that's not terribly blind.


pyker said...

Hey, they're looking at outcomes and not lab vslues! That's a good thing.

JustJoeP said...

I love my B vitamins and will continue to ingest them daily.