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.


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.


CONCLUSIONS
The lipid-modifying effects of ERN/LRPT are independent of the degree of baseline glycemic control in patients with T2DM (NCT00485758).
Louisville Metabolic & Atherosclerosis Research Center (L-MARC), Louisville, KY, USA.
Harold E
HE
Bays
Utah Foundation for Biomedical Research, Salt Lake City, UT, USA.
Eliot A
EA
Brinton
Merck & Co, Inc., Whitehouse Station, NJ, USA.
Joseph
J
Triscari
Merck & Co, Inc., Whitehouse Station, NJ, USA.
Erluo
E
Chen
Merck & Co, Inc., Whitehouse Station, NJ, USA.
Darbie
D
Maccubbin
Merck & Co, Inc., Whitehouse Station, NJ, USA.
Alexandra A
AA
MacLean
Merck & Co, Inc., Whitehouse Station, NJ, USA.
Kendra L
KL
Gibson
Merck & Co, Inc., Whitehouse Station, NJ, USA.
Rae Ann
RA
Ruck
Merck & Co, Inc., Whitehouse Station, NJ, USA.
Amy O
AO
Johnson-Levonas
Merck & Co, Inc., Whitehouse Station, NJ, USA.
Edward A
EA
O'Neill
Merck & Co, Inc., Whitehouse Station, NJ, USA.
Yale B
YB
Mitchel
D000368:Aged; D015415:Biomarkers / Q000097:blood*; D001786:Blood Glucose / Q000187:drug effects* / Q000378:metabolism; D003692:Delayed-Action Preparations; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D004311:Double-Blind Method; D004338:Drug Combinations; D004347:Drug Interactions; D050171:Dyslipidemias / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000960:Hypolipidemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007211:Indoles / Q000009:adverse effects / Q000627:therapeutic use*; D008055:Lipids / Q000097:blood*; D008297:Male; D008875:Middle Aged; D009525:Niacin / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
D015415:Biomarkers; D001786:Blood Glucose; D003692:Delayed-Action Preparations; D004338:Drug Combinations; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000960:Hypolipidemic Agents; D007211:Indoles; D008055:Lipids; D009525:Niacin; C518174:MK-0524; C517652:hemoglobin A1c protein, human
HDL; LDL; hyperglycemia; lipid-modifying agents; triglycerides