title: Lipid-modifying efficacy of extended release niacin/laropiprant in Asian patients with primary hypercholesterolemia or mixed hyperlipidemia.
abstract: BACKGROUND
  Niacin has proven lipid-modifying efficacy and cardiovascular benefit; however, it is underused because of skin flushing, a process mediated primarily by prostaglandin D(2) (PGD(2)). Laropiprant (LRPT), a PGD(2) receptor (DP1) antagonist that mitigates niacin-induced flushing, has been combined with extended-release niacin (ERN) into a fixed-dose tablet containing 1g of ERN and 20mg of LRPT (ERN/LRPT 1g). In a large-scale (n=∼1600), multinational, 6-month study in dyslipidemic patients, ERN/LRPT 2g produced superior lipid-modifying efficacy vs placebo, whether administered alone or with concomitant statins.
  
  
  OBJECTIVE
  This Phase III, randomized, double-blind study evaluated the lipid-modifying efficacy of ERN/LRPT alone or added to ongoing statins in Asian patients with primary hypercholesterolemia or mixed hyperlipidemia.
  
  
  METHODS
  After a 4-week placebo run-in, patients were randomized to ERN/LRPT 1g (n=322) or placebo (PBO; n=324). After 4 weeks, the dose was advanced to 2 tablets/d (ERN/LRPT 2g or PBO) for 8 additional weeks. End points included effects of ERN/LRPT 2g vs PBO on low-density lipoprotein cholesterol (LDL-C; primary), high-density lipoprotein cholesterol (HDL-C), triglyceride (TG), and other lipids/lipoproteins.
  
  
  RESULTS
  Relative to PBO, ERN/LRPT 2g produced significant (P < .001) changes in LDL-C (-14.7%), HDL-C (15.9%), TG (-23.4%), LDL-C:HDL-C (-25.5%), non-HDL-C (-16.4%), apolipoprotein (Apo) B (-15.4%), and Apo A-I (5.3%) from baseline to week 12 in the total population. Similar results were observed in patients treated with ERN/LRPT alone or added to ongoing statin.
  
  
  CONCLUSIONS
  ERN/LRPT 2g, administered alone or with a statin, produced significant improvements in multiple lipid/lipoprotein parameters in dyslipidemic Asian patients.
authors.affiliation: Merck Research Laboratories, 126 East Lincoln Avenue, RY34A-218, Rahway, New Jersey, 07065 USA.
authors.forename: Debra
authors.initials: D
authors.lastname: Kush
authors.forename: Hyo-Soo
authors.initials: HS
authors.lastname: Kim
authors.forename: Da Yi
authors.initials: DY
authors.lastname: Hu
authors.forename: Ji
authors.initials: J
authors.lastname: Liu
authors.forename: Waheeda
authors.initials: W
authors.lastname: Sirah
authors.forename: Aditi
authors.initials: A
authors.lastname: Sapre
authors.forename: Christine
authors.initials: C
authors.lastname: McCrary Sisk
authors.forename: John F
authors.initials: JF
authors.lastname: Paolini
authors.forename: Darbie
authors.initials: D
authors.lastname: Maccubbin