Friday, July 18, 2014

NEJM Formally Publishes Tredaptive Results We Reported In December of 2012 -- "Niacin Clanks" Chronicles

Truthfully, this scarcely qualifies as news. But it has been a slow summer dog's week around Whitehouse Station. These results were first released, on a top line basis, in December of 2012. And we covered them. But the message is clear: Niacin plus laropiprant is probably a dead letter -- and often exhibits a side-effect profile that should not be considered an acceptable risk. [Additional March 2013 vintage background here.] To be sure, it has taken a while -- for Merck's science speakers to come around to this plainly majority view. But it is definitive, now (even if the possibility of infections hadn't been seen -- the lack of outcomes benefit should be the end, all by itself).

From the Monthly Prescribing Reference, then -- a bit:

. . . .Extended-release niacin with laropiprant does not reduce the risk of major vascular events in adults with vascular disease; and extended-release niacin may be associated with increased risk of certain serious adverse events, according to research published in the July 17 issue of the New England Journal of Medicine. . . .

"The findings concerning certain serious adverse infectious events associated with niacin have not been previously reported," Anderson and colleagues write. . . .

Go find a summer adventure this weekend -- I certainly intend to!

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