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

Abstract

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.

Results

At Week 12 of treatment, ERN/LRPT significantly improved low-density lipoprotein cholesterol, high-density lipoprotein cholesterol (HDL-C), non-high-density lipoprotein cholesterol, triglycerides, and lipoprotein (a), compared with placebo, with equal efficacy in patients above or below median baseline glycemic control. Compared with placebo, over 36 weeks of treatment more patients treated with ERN/LRPT had worsening of their diabetes and required intensification of antihyperglycemic medication, irrespective of baseline glycemic control. Incidences of other adverse experiences were generally low in all treatment groups.

Conclusion

The lipid-modifying effects of ERN/LRPT are independent of the degree of baseline glycemic control in patients with T2DM (NCT00485758).

Keywords:

• lipid-modifying agents
• hyperglycemia
• LDL
• HDL
• triglycerides

Acknowledgments

This analysis was funded by Merck & Co, Inc., Whitehouse Station, NJ, USA. The authors gratefully acknowledge the assistance of Kristen Lewis and Kathleen Newcomb of Merck & Co, Inc., Whitehouse Station, NJ, USA, in the production and submission of the manuscript.

Disclosure

JT, EC, DM, AAM, KLG, RAR, AOJ-L, EAO and YBM are current or former employees of Merck & Co, Inc., Whitehouse Station, NJ, USA, and may own stock and/or hold stock options in the company. HEB has received research grants as investigator and honoraria as a consultant and has served on advisory board and speaker’s bureau for Merck & Co, Inc. EAB has received research grants and honoraria from Merck & Co, Inc.