How effective is high-dose niacin in the treatment of hypertriglyceridemia (high triglyceride level) and what is the FDA's stance on niacin-statin coadministration?

Updated: Dec 19, 2019
  • Author: Mary Ellen T Sweeney, MD; Chief Editor: Romesh Khardori, MD, PhD, FACP  more...
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Answer

High-dose niacin (vitamin B-3) (1500 or more mg/d) decreases triglyceride levels by at least 40% and can raise HDL cholesterol levels by 40% or more. [42] Niacin also reliably and significantly lowers LDL cholesterol levels, which the other major triglyceride-lowering medications do not. In the Coronary Drug Project, niacin, in comparison with placebo, reduced coronary events. [64]

Although extended-release niacin had been approved by the FDA for coadministration with statin for treatment of primary hyperlipidemia and mixed lipidemia, the FDA withdrew approval for this indication when the agency found that, in light of several large trials, "scientific evidence no longer supports the conclusion that a drug-induced reduction in triglyceride levels and/or increase in HDL-cholesterol levels in statin-treated patients results in a reduction in the risk of cardiovascular events." [57, 58]


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