Lipid-modifying efficacy of extended release niacin/laropiprant in Asian patients with primary hypercholesterolemia or mixed hyperlipidemia

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 (DPI) antagonist that mitigates niacin-induced flushing, has been combined with extended-release niacin (ERN) into a fixed-dose tablet containing I of ERN and 20 mg of LRPT (ERN/LRPT 1 g). In a large-scale (n = similar to 1600), multinational, 6-month study in dyslipidemic patients, ERN/LRPT 2 g 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 I g (n = 322) or placebo (PBO; n = 324). After 4 weeks, the dose was advanced to 2 tablets/d (ERN/LRPT 2 g or PBO) for 8 additional weeks. End points included effects of ERN/LRPT 2 g vs P130 on low-density lipoprotein cholesterol (LDL-C; primary), high-density lipoprotein cholesterol (HDL-C), triglyceride (TG), and other lipids/lipoproteins. RESULTS: Relative to P130, ERN/LRPT 2 g 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. CONCLUSION: ERN/LRPT 2 g, administered alone or with a statin, produced significant improvements in multiple lipid/lipoprotein parameters in dyslipidemic Asian patients. (C) 2009 National Lipid Association. All rights reserved.http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000267614700005&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=8e1609b174ce4e31116a60747a720701Pharmacology & PharmacySCI(E)CPCI-S(ISTP)