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Niacin is Dead, Long Live Niacin!

Posted Mar 10 2013 4:00am

So this blind squirrel (me) isn't very good at finding acorns.  I completely overlooked & missed the significance of a randomized controlled trial (HPS2-THRIVE) published early last week in the European Heart Journal in which the authors noted that the addition of niacin + laropiprant (novel anti-flushing agent) to simvastatin +/- ezetimibe increased the risk of myopathy, especially in those participants of Chinese descent.  To the authors' credit, of those 38,369 participants who were able to tolerate the drug for at least a month, 3 out of 4 were then followed for 4yrs.

What made me dig for this article was the announcement yesterday at the American College of Cardiology's annual meeting regarding the study's findings : increase in diabetic complications, increase in new onset diabetes, increase in infections, gastrointestinal complications & bleeding, and most importantly, no statistically significant benefit in vascular outcomes .  In other words, when it comes to niacin + laropiprant, risk exceeds benefit.  

Thus, the headlines read "HPS2-THRIVE May Signal the End for Niacin".  But was this really a study of niacin or niacin + laropiprant?  I would wager it's the latter since there were really only 2 major arms to this study: niacin + laropiprant vs placebo, since everyone else was already on simvastatin +/- ezetimibe.  Some claimed foul since a good portion of the participants were from China whose population is known to have a higher risk of statin-induced myopathy.

Merck, the manufacturer of Tredaptive branded niacin + laropiprant, must've known the gig was up because it stopped selling the drug outside of the US back in January , 2 months ago, after these negative results were announced in December .  Bottom line: I don't think niacin is dead (yet) but niacin + laropiprant certainly doesn't look too healthy.  
The King is dead. Long live the King! Le Roi est mort. Vive le Roi!

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