title: Consistency of extended-release niacin/laropiprant effects on Lp(a), ApoB, non-HDL-C, Apo A1, and ApoB/ApoA1 ratio across patient subgroups.
abstract: BACKGROUND
  According to prior analyses, extended-release niacin/laropiprant (ERN/LRPT) consistently reduces low-density lipoprotein cholesterol (LDL-C) and triglycerides (TG) and increases high-density lipoprotein cholesterol (HDL-C) levels across a wide range of dyslipidemic patient subgroups.
  
  
  OBJECTIVE
  This analysis examined ERN/LRPT's consistency across four phase III, randomized, double-blind trials in improving other lipid/lipoprotein parameters associated with cardiovascular risk, across several key dyslipidemic patient subgroups.
  
  
  METHODS
  In three of the studies, the randomized population included patients with primary hypercholesterolemia or mixed hyperlipidemia; in the remaining study, the population included patients with type 2 diabetes mellitus. The lipid-altering consistency of ERN/LRPT's efficacy was evaluated versus the pre-defined comparator (placebo or active control) among key subgroups of sex, race (White, non-White), region (US, ex-US), baseline age (<65 years, ≥65 years), use of statin therapy (yes, no), coronary heart disease (yes, no), risk status (low, multiple, high), and type of hyperlipidemia (primary hypercholesterolemia, mixed dyslipidemia), as well as across baseline LDL-C, HDL-C, and TG levels. The consistency of the treatment effects on lipoprotein(a).[Lp(a)], apolipoprotein B (ApoB), non-HDL-C, ApoA1, and ApoB/ApoA1 ratio was evaluated by examining treatment difference estimates of the percentage change from baseline with 95% confidence intervals.
  
  
  RESULTS
  Treatment with ERN/LRPT produced significantly greater improvements in Lp(a), ApoB, non-HDL-C, ApoA1, and ApoB/ApoA1 ratio compared with placebo/active comparator in each study. These effects were generally consistent across key subgroups within each study.
  
  
  CONCLUSIONS
  ERN/LRPT produced lipid-altering efficacy on the parameters evaluated in four controlled studies; these effects were generally consistent across all examined subgroups. ERN/LRPT represents an effective and reliable therapeutic option for the treatment of dyslipidemia in a wide range of patient types.
  
  
  BACKGROUND
  Registered as Clinicaltrials.gov NCT00269204, NCT00269217, NCT00479388, and NCT00485758.
authors.affiliation: L-MARC Research Center, Louisville, KY 40213, USA. hbaysmd@aol.com
authors.forename: Harold E
authors.initials: HE
authors.lastname: Bays
authors.forename: Arvind
authors.initials: A
authors.lastname: Shah
authors.forename: Jianxin
authors.initials: J
authors.lastname: Lin
authors.forename: Christine McCrary
authors.initials: CM
authors.lastname: Sisk
authors.forename: Qian
authors.initials: Q
authors.lastname: Dong
authors.forename: Darbie
authors.initials: D
authors.lastname: Maccubbin
mesh_terms: D000368:Aged; D016632:Apolipoprotein A-I / Q000187:drug effects / Q000378:metabolism; D001055:Apolipoproteins B / Q000187:drug effects / Q000378:metabolism; D002318:Cardiovascular Diseases / Q000209:etiology; D017326:Clinical Trials, Phase III as Topic; D003692:Delayed-Action Preparations; D003924:Diabetes Mellitus, Type 2 / Q000209:etiology; D004311:Double-Blind Method; D050171:Dyslipidemias / Q000188:drug therapy*; D005260:Female; D006801:Humans; D000960:Hypolipidemic Agents / Q000008:administration & dosage / Q000494:pharmacology; D007211:Indoles / Q000008:administration & dosage / Q000494:pharmacology*; D008055:Lipids / Q000097:blood; D017270:Lipoprotein(a) / Q000187:drug effects / Q000378:metabolism; D008297:Male; D009525:Niacin / Q000008:administration & dosage / Q000494:pharmacology*; D016032:Randomized Controlled Trials as Topic
chemical_list: D016632:Apolipoprotein A-I; D001055:Apolipoproteins B; D003692:Delayed-Action Preparations; D000960:Hypolipidemic Agents; D007211:Indoles; D008055:Lipids; D017270:Lipoprotein(a); C518174:MK-0524; D009525:Niacin