Effects of extended-release niacin/laropiprant on correlations between apolipoprotein B, LDL-cholesterol and non-HDL-cholesterol in patients with type 2 diabetes.

Background: LDL-C, non-HDL-C and ApoB levels are inter-correlated and all predict risk of atherosclerotic cardiovascular disease (ASCVD) in patients with type 2 diabetes mellitus (T2DM) and/or high TG. These levels are lowered by extended-release niacin (ERN), and changes in the ratios of these levels may affect ASCVD risk. This analysis examined the effects of extended-release niacin/laropiprant (ERN/LRPT) on the relationships between apoB:LDL-C and apoB:non-HDL-C in patients with T2DM.

Safety and tolerability of extended-release niacin-laropiprant: Pooled analyses for 11,310 patients in 12 controlled clinical trials.

Background: 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 (PBO). ERN-LRPT was also associated with an excess of serious adverse experiences (AEs), some of which were unexpected (infections and bleeding). These findings led to the withdrawal of ERN-LRPT from all markets.

Extended-release niacin/laropiprant significantly improves lipid levels in type 2 diabetes mellitus irrespective of baseline glycemic control.

Background: The degree of glycemic control in patients with type 2 diabetes mellitus (T2DM) may alter lipid levels and may alter the efficacy of lipid-modifying agents.

Objective: Evaluate the lipid-modifying efficacy of extended-release niacin/laropiprant (ERN/LRPT) in subgroups of patients with T2DM with better or poorer glycemic control.

Methods: Post hoc analysis of clinical trial data from patients with T2DM who were randomized 4:3 to double-blind ERN/LRPT or placebo (n=796), examining the lipid-modifying effects of ERN/LRPT in patients with glycosylated hemoglobin or fasting plasma glucose levels above and below median baseline levels.

The association of flushing bother, impact, treatment satisfaction and discontinuation of niacin therapy.

Background: Niacin has lipid-modifying efficacy and cardiovascular benefit, but is underutilised because of niacin-induced flushing (NIF). This real-world, prospective, observational study characterised the severity and impact of NIF symptoms among participants who were newly prescribed extended-release (ER) niacin.

Methods: Participants were surveyed daily during week 1 of therapy, at weeks 5, 9, 13, and at months 7, 10 and 13.

Effects of niacin on the incidence of new onset diabetes and cardiovascular events in patients with normoglycaemia and impaired fasting glucose.

Background: This post hoc analysis from the Coronary Drug Project (CDP) evaluated the effects of niacin vs. placebo on the incidence of new onset type 2 diabetes mellitus (T2DM) and cardiovascular event rates in patients with normal and impaired fasting glucose (IFG).

Methods: The CDP was a randomised, placebo-controlled clinical trial of lipid-modifying agents in men with previous myocardial infarction.