PMID- 25750540 OWN - NLM STAT- MEDLINE DCOM- 20151019 LR - 20221207 IS - 1178-2048 (Electronic) IS - 1176-6344 (Print) IS - 1176-6344 (Linking) VI - 11 DP - 2015 TI - Extended-release niacin/laropiprant significantly improves lipid levels in type 2 diabetes mellitus irrespective of baseline glycemic control. PG - 165-72 LID - 10.2147/VHRM.S70907 [doi] AB - 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). FAU - Bays, Harold E AU - Bays HE AD - Louisville Metabolic & Atherosclerosis Research Center (L-MARC), Louisville, KY, USA. FAU - Brinton, Eliot A AU - Brinton EA AD - Utah Foundation for Biomedical Research, Salt Lake City, UT, USA. FAU - Triscari, Joseph AU - Triscari J AD - Merck & Co, Inc., Whitehouse Station, NJ, USA. FAU - Chen, Erluo AU - Chen E AD - Merck & Co, Inc., Whitehouse Station, NJ, USA. FAU - Maccubbin, Darbie AU - Maccubbin D AD - Merck & Co, Inc., Whitehouse Station, NJ, USA. FAU - MacLean, Alexandra A AU - MacLean AA AD - Merck & Co, Inc., Whitehouse Station, NJ, USA. FAU - Gibson, Kendra L AU - Gibson KL AD - Merck & Co, Inc., Whitehouse Station, NJ, USA. FAU - Ruck, Rae Ann AU - Ruck RA AD - Merck & Co, Inc., Whitehouse Station, NJ, USA. FAU - Johnson-Levonas, Amy O AU - Johnson-Levonas AO AD - Merck & Co, Inc., Whitehouse Station, NJ, USA. FAU - O'Neill, Edward A AU - O'Neill EA AD - Merck & Co, Inc., Whitehouse Station, NJ, USA. FAU - Mitchel, Yale B AU - Mitchel YB AD - Merck & Co, Inc., Whitehouse Station, NJ, USA. LA - eng SI - ClinicalTrials.gov/NCT00485758 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20150224 PL - New Zealand TA - Vasc Health Risk Manag JT - Vascular health and risk management JID - 101273479 RN - 0 (Biomarkers) RN - 0 (Blood Glucose) RN - 0 (Delayed-Action Preparations) RN - 0 (Drug Combinations) RN - 0 (Glycated Hemoglobin A) RN - 0 (Hypoglycemic Agents) RN - 0 (Hypolipidemic Agents) RN - 0 (Indoles) RN - 0 (Lipids) RN - 0 (MK-0524) RN - 0 (hemoglobin A1c protein, human) RN - 2679MF687A (Niacin) SB - IM MH - Aged MH - Biomarkers/*blood MH - Blood Glucose/*drug effects/metabolism MH - Delayed-Action Preparations MH - Diabetes Mellitus, Type 2/blood/diagnosis/*drug therapy MH - Double-Blind Method MH - Drug Combinations MH - Drug Interactions MH - Dyslipidemias/blood/diagnosis/*drug therapy MH - Female MH - Glycated Hemoglobin/metabolism MH - Humans MH - Hypoglycemic Agents/adverse effects/*therapeutic use MH - Hypolipidemic Agents/adverse effects/*therapeutic use MH - Indoles/adverse effects/*therapeutic use MH - Lipids/*blood MH - Male MH - Middle Aged MH - Niacin/adverse effects/*therapeutic use MH - Time Factors MH - Treatment Outcome PMC - PMC4348131 OTO - NOTNLM OT - HDL OT - LDL OT - hyperglycemia OT - lipid-modifying agents OT - triglycerides EDAT- 2015/03/10 06:00 MHDA- 2015/10/20 06:00 PMCR- 2015/02/24 CRDT- 2015/03/10 06:00 PHST- 2015/03/10 06:00 [entrez] PHST- 2015/03/10 06:00 [pubmed] PHST- 2015/10/20 06:00 [medline] PHST- 2015/02/24 00:00 [pmc-release] AID - vhrm-11-165 [pii] AID - 10.2147/VHRM.S70907 [doi] PST - epublish SO - Vasc Health Risk Manag. 2015 Feb 24;11:165-72. doi: 10.2147/VHRM.S70907. eCollection 2015.