The Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events ( HPS2-THRIVE ) showed that adding extended-release Niacin-Laropiprant ( ERN-LRPT ) to statin provided no incremental cardiovascular benefit vs placebo.
The combination of Niacin and Laropiprant was also associated with an excess of serious adverse experiences, some of which were unexpected ( infections and bleeding ).
These findings led to the withdrawal of combination of Niacin and Laropiprant from all markets.
Researchers have examined the safety profile of combination of Niacin and Laropiprant vs the comparators Niacin alone and statins in the ERN-LRPT development Program to assess whether similar safety signals were observed to those seen in HPS-THRIVE and whether these might be attributed to Niacin or Laropiprant.
Postrandomization safety data from 12 clinical studies, 12 to 52 weeks in duration and involving 11,310 patients, were analyzed across 3 treatments: (1) Niacin-Laropiprant; (2) Niacin-Niaspan [ Niacin extended-release ]; and (3) statin-placebo ( statin or placebo ).
The safety profiles of Niacin-Laropiprant and Niacin-Niaspan were similar, except for less flushing with Niacin-Laropiprant.
Nonflushing adverse effects reported more frequently with Niacin-Laropiprant or Niacin-Niaspan than with statin-placebo were mostly nonserious and typical of niacin ( nausea, diarrhea, and increased blood glucose ).
There was no evidence for an increased risk of serious adverse effects related to diabetes, muscle, infection, or bleeding.
In conclusion, pooled data from 11,310 patients revealed that, except for reduced flushing, the safety profile of Niacin-Laropiprant was similar to that of Niacin-Niaspan; Laropiprant did not appear to adversely affect the side-effect profile of Niacin.
The inability to replicate the unexpected adverse effects findings in HPS2-THRIVE could be because of the smaller sample size and substantially shorter duration of these studies. ( Xagena )
McKenney J et al, J Clin Lipidol 2015;9:313-325